Drugs Details

Drugs Info of Lantus, Lantus OptiClik Cartridge, Lantus Solostar Pen
Drugs Details
  • Drugs Type  : FDA
  • Date : 12th Feb 2015 02:51 am
  • Brand Name : Lantus, Lantus OptiClik Cartridge, Lantus Solostar Pen
  • Generic Name : insulin glargine (Pronunciation: IN su lin AS part, IN su lin AS part PRO ta meen)
Descriptions

LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent [See CLINICAL PHARMACOLOGY]. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. Insulin glargine has the following structural formula:

 

LANTUS (insulin glargine [rDNA origin] injection)Structural Formula Illustration

LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 Units (3.6378 mg) insulin glargine.

The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. The 3 mL cartridge presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4.

What are the possible side effects of insulin glargine (Lantus, Lantus OptiClik Cartridge, Lantus Solostar Pen)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glargine. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets...

Read All Potential Side Effects and See Pictures of Lantus »

What are the precautions when taking insulin glargine [rdna origin] injection (Lantus)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor...

Read All Potential Precautions of Lantus »

This monograph has been modified to include the generic and brand name in many instances.

Indications

LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Important Limitations of Use

  • LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition.

Dosage Administration

Dosing

LANTUS is a recombinant human insulin analog for once daily subcutaneous administration with potency that is approximately the same as the potency of human insulin. LANTUS exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing.

LANTUS may be administered at any time during the day. LANTUS should be administered subcutaneously once a day at the same time every day. The dose of LANTUS must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy.

Patients adjusting the amount or timing of dosing with LANTUS, should only do so under medical supervision with appropriate glucose monitoring [see WARNINGS AND PRECAUTIONS]

In patients with type 1 diabetes, LANTUS must be used in regimens with short-acting insulin.

The intended duration of activity of LANTUS is dependent on injection into subcutaneous tissue [see CLINICAL PHARMACOLOGY]. LANTUS should not be administered intravenously or via an insulin pump. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia [see WARNINGS AND PRECAUTIONS].

As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy [See ADVERSE REACTIONS].

In clinical studies, there was no clinically relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered drugs or meal patterns.

Initiation of LANTUS therapy

The recommended starting dose of LANTUS in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.

The recommended starting dose of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.

The dose of LANTUS should be adjusted according to blood glucose measurements. The dosage of LANTUS should be individualized under the supervision of a healthcare provider in accordance with the needs of the patient.

Converting to LANTUS from other insulin therapies

If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with LANTUS, the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.

  • If transferring patients from once-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is the same as the dose of NPH that is being discontinued.
  • If transferring patients from twice-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is 80% of the total NPH dose that is being discontinued. This dose reduction will lower the likelihood of hypoglycemia [see WARNINGS AND PRECAUTIONS].

How Supplied

Dosage Forms And Strengths

LANTUS solution for injection 100 Units per mL is available as:

  • 10 mL Vial (1000 Units/10 mL)
  • 3 mL Cartridge systems for use only in OptiClik® (300 Units/3 mL)
  • 3 mL SoloStar® disposable insulin device (300 Units/3 mL)

Storage And Handling

LANTUS solution for injection 100 units per mL (U-100) is available as:

 

Dosage Unit/Strength Package size NDC # 00886
10 mL vials
100 Units/mL Pack of 1 2220-33
3 mL cartridge system*
100 Units/mL package of 5 2220-52
3 mL SoloStar® disposable insulin device
100 Units/mL package of 5 2220-60
*Cartridge systems are for use only in OptiClik® (Insulin Delivery Device)

Needles are not included in the packs. BD Ultra-Fine™ needles‡ to be used in conjunction with SoloStar and OptiClik are sold separately and are manufactured by BD.

Storage

LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.

Unopened Vial/Cartridge system/SoloStar disposable insulin device

Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F - 46°F (2°C - 8°C). Discard after the expiration date.

Open (In-Use) Vial

Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C).

Open (In-Use) Cartridge system

The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.

Open (In-Use) SoloStar disposable insulin device

The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.

These storage conditions are summarized in the following table:

 

  Not in-use (unopened) Refrigerated Not in-use (unopened) Room Temperature In-use (opened) (See Temperature Below)
10 mL Vial Until expiration date 28 days 28 days Refrigerated or room temperature
3 mL Cartridge system Until expiration date 28 days 28 days Refrigerated or room temperature
3 mL Cartridge system® inserted into OptiClik     28 days Room temperature only (Do not refrigerate)
3 mL SoloStar® disposable insulin device Until expiration date 28 days 28 days Room temperature only (Do not refrigerate)

Preparation and handling

Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. LANTUS must only be used if the solution is clear and colorless with no particles visible.

Mixing and diluting: LANTUS must NOT be diluted or mixed with any other insulin or solution [See WARNINGS AND PRECAUTIONS].

Vial: The syringes must not contain any other medicinal product or residue.

Cartridge system/SoloStar: If OptiClik, the Insulin Delivery Device used with the LANTUS cartridge system, or SoloStar disposable insulin device, malfunctions, LANTUS may be drawn from the cartridge system or from SoloStar into a U-100 syringe and injected.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807, Rev. June 2009

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions are discussed elsewhere:

  • Hypoglycemia [See WARNINGS AND PRECAUTIONS]
  • Hypersensitivity and allergic reactions [See WARNINGS AND PRECAUTIONS]

Clinical trial experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

The frequencies of treatment-emergent adverse events during LANTUS clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Treatment –emergent adverse events in pooled clinical trials up to 28 weeks duration in adults with type 1 diabetes (adverse events with frequency ≥ 5%)

  LANTUS, %
(n=1257)
NPH, %
(n=1070)
Upper respiratory tract infection 22.4 23.1
Infection * 9.4 10.3
Accidental injury 5.7 6.4
Headache 5.5 4.7
*Body System not Specified

Table 2: Treatment –emergent adverse events in pooled clinical trials up to 1 year duration in adults with type 2 diabetes (adverse events with frequency ≥ 5%)

  LANTUS, %
(n=849)
NPH, %
(n=714)
Upper respiratory tract infection 11.4 13.3
Infection* 10.4 11.6
Retinal vascular disorder 5.8 7.4
*Body System not Specified

Table 3: Treatment –emergent adverse events in a 5-year trial of adults with type 2 diabetes (adverse events with frequency ≥ 10%)

  LANTUS, %
(n=514)
NPH, %
(n=503)
Upper respiratory tract infection 29 33.6
Edema peripheral 20 22.7
Hypertension 19.6 18.9
Influenza 18.7 19.5
Sinusitis 18.5 17.9
Cataract 18.1 15.9
Bronchitis 15.2 14.1
Arthralgia 14.2 16.1
Pain in extremity 13 13.1
Back pain 12.8 12.3
Cough 12.1 7.4
Urinary tract infection 10.7 10.1
Diarrhea 10.7 10.3
Depression 10.5 9.7
Headache 10.3 9.3

Table 4: Treatment –emergent adverse events in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse events with frequency ≥ 5%)

  LANTUS, %
(n=174)
NPH, %
(n=175)
Infection* 13.8 17.7
Upper respiratory tract infection 13.8 16
Pharyngitis 7.5 8.6
Rhinitis 5.2 5.1
*Body System not Specified
Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LANTUS [See WARNINGS AND PRECAUTIONS]. Tables 5 and 6 summarize the incidence of severe hypoglycemia in the LANTUS individual clinical trials. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL ( ≤ 56 mg/dL in the 5-year trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. The rates of severe symptomatic hypoglycemia in the LANTUS clinical trials (see Section 14 for a description of the study designs) were comparable for all treatment regimens (see Tables 5 and 6). In the pediatric phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult trials with type 1 diabetes. (see Table 5) [See Clinical Studies].

Table 5: Severe Symptomatic Hypoglycemia in Patients with Type 1 Diabetes

View Enlarged Table

Table 6: Severe Symptomatic Hypoglycemia in Patients with Type 2 Diabetes

View Enlarged Table
Retinopathy

Retinopathy was evaluated in the LANTUS clinical studies by analysis of reported retinal adverse events and fundus photography. The numbers of retinal adverse events reported for LANTUS and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes.

LANTUS was compared to NPH insulin in a 5-year randomized clinical trial that evaluated the progression of retinopathy as assessed with fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Scale (ETDRS). Patients had type 2 diabetes (mean age 55 yrs) with no (86%) or mild (14%) retinopathy at baseline. Mean baseline HbA1c was 8.4%. The primary outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. Patients with pre-specified post-baseline eye procedures (pan-retinal photocoagulation for proliferative or severe nonproliferative diabetic retinopathy, local photocoagulation for new vessels, and vitrectomy for diabetic retinopathy) were also considered as 3-step progressors regardless of actual change in ETDRS score from baseline. Retinopathy graders were blinded to treatment group assignment. The results for the primary endpoint are shown in Table 7 for both the per-protocol and Intent-to-Treat populations, and indicate similarity of Lantus to NPH in the progression of diabetic retinopathy as assessed by this outcome.

Table 7: Number (%) of patients with 3 or more step progression on ETDRS scale at endpoint

  Lantus (%) NPH (%) Differencea,b (SE) 95% CI for difference
Per-protocol 53/374 (14.2%) 57/363 (15.7%) -2.0% (2.6%) -7.0% to +3.1%
Intent-to-Treat 63/502 (12.5%) 71/487 (14.6%) - 2.1% (2.1%) -6.3% to +2.1%
a Difference = Lantus – NPH
b using a generalized linear model (SAS GENMOD) with treatment and baseline HbA1c strata (cutoff 9.0%) as the classified independent variables, and with binomial distribution and identity link function
Insulin initiation and intensification of glucose control

Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Lipodystrophy

Long-term use of insulin, including LANTUS, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy. [See DOSAGE AND ADMINISTRATION].

Weight gain

Weight gain can occur with insulin therapy, including LANTUS, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Peripheral Edema

Insulin, including LANTUS, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Allergic Reactions

Local Allergy

As with any insulin therapy, patients taking LANTUS may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. In clinical studies in adult patients, there was a higher incidence of treatment-emergent injection site pain in LANTUS-treated patients (2.7%) compared to NPH insulin-treated patients (0.7%). The reports of pain at the injection site did not result in discontinuation of therapy.

Rotation of the injection site within a given area from one injection to the next may help to reduce or prevent these reactions. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Most minor reactions to insulin usually resolve in a few days to a few weeks.

Systemic Allergy

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LANTUS and may be life threatening.

Antibody production

All insulin products can elicit the formation of insulin antibodies. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In phase 3 clinical trials of LANTUS, increases in titers of antibodies to insulin were observed in NPH insulin and insulin glargine treatment groups with similar incidences.

Postmarketing experience

The following adverse reactions have been identified during post-approval use of LANTUS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of LANTUS [See PATIENT INFORMATION]. To avoid medication errors between LANTUS and other insulins, patients should be instructed to always verify the insulin label before each injection.

Read the Lantus (insulin glargine [rdna origin] injection) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

A number of drugs affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

The following are examples of drugs that may increase the blood-glucose-lowering effect of insulins including LANTUS and, therefore, increase the susceptibility to hypoglycemia: oral anti-diabetic products, pramlintide, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics.

The following are examples of drugs that may reduce the blood-glucose-lowering effect of insulins including LANTUS: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the bloodglucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.

Read the Lantus Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Dosage adjustment and monitoring

Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision.

Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral anti-diabetic treatment.

As with all insulin preparations, the time course of action for LANTUS may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the local blood supply, local temperature, and physical activity.

Administration

Do not administer LANTUS intravenously or via an insulin pump. The intended duration of activity of LANTUS is dependent on injection into subcutaneous tissue Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

Do not dilute or mix LANTUS with any other insulin or solution. If LANTUS is diluted or mixed, the solution may become cloudy, and the pharmacokinetic or pharmacodynamic profile (e.g., onset of action, time to peak effect) of LANTUS and the mixed insulin may be altered in an unpredictable manner. When LANTUS and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and a delayed time to maximum effect for regular human insulin was observed. The total bioavailability of the mixture was also slightly decreased compared to separate injections of LANTUS and regular human insulin. The relevance of these observations in dogs to humans is unknown.

Do not share disposable or reusable insulin devices or needles between patients, because doing so carries a risk for transmission of blood-borne pathogens.

Hypoglycemia

Hypoglycemia is the most common adverse reaction of insulin, including LANTUS. The risk of hypoglycemia increases with intensive glycemic control. Patients must be educated to recognize and manage hypoglycemia. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with LANTUS.

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), exercise, and concomitant medications may also alter the risk of hypoglycemia [See DRUG INTERACTIONS].

The prolonged effect of subcutaneous LANTUS may delay recovery from hypoglycemia. Patients being switched from twice daily NPH insulin to once-daily LANTUS should have their initial LANTUS dose reduced by 20% from the previous total daily NPH dose to reduce the risk of hypoglycemia [see DOSAGE AND ADMINISTRATION].

As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic neuropathy, use of medications such as beta-blockers, or intensified glycemic control. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia.

Hypersensitivity and allergic reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LANTUS.

Renal impairment

Due to its long duration of action, Lantus is not recommended during periods of rapidly declining renal function because of the risk for prolonged hypoglycemia. Although studies have not been performed in patients with diabetes and renal impairment, a reduction in the LANTUS dose may be required in patients with renal impairment because of reduced insulin metabolism, similar to observations found with other insulins. [See CLINICAL PHARMACOLOGY].

Hepatic impairment

Due to its long duration of action, Lantus is not recommended during periods of rapidly declining hepatic function because of the risk for prolonged hypoglycemia. Although studies have not been performed in patients with diabetes and hepatic impairment, a reduction in the LANTUS dose may be required in patients with hepatic impairment because of reduced capacity for gluconeogenesis and reduced insulin metabolism, similar to observations found with other insulins. [See CLINICAL PHARMACOLOGY].

Drug interactions

Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia or hyperglycemia [See DRUG INTERACTIONS].

Patient Counseling Information

Instructions for patients

Patients should be informed that changes to insulin regimens must be made cautiously and only under medical supervision.

Patients should be informed about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia. Patients should be informed that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or operating machinery.

Accidental mix-ups between LANTUS and other insulins, particularly short-acting insulins, have been reported. To avoid medication errors between LANTUS and other insulins, patients should be instructed to always check the insulin label before each injection.

LANTUS must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that LANTUS must NOT be diluted or mixed with any other insulin or solution.

Patients should be advised not to share disposable or reusable insulin devices or needles with other patients, because doing so carries a risk for transmission of blood-borne pathogens.

Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy.

Refer patients to the LANTUS “PATIENT INFORMATION” for additional information.

See attached document at end of Full Prescribing Information.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 10 times and for the mouse approximately 5 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m². The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.

Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames- and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters).

In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m², maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m². In rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m², were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

There are no well-controlled clinical studies of the use of LANTUS in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients.

Nursing Mothers

It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when LANTUS is administered to a nursing woman. Use of LANTUS is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric Use

The safety and effectiveness of subcutaneous injections of LANTUS have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes [see Clinical Studies]. LANTUS has not been studied in pediatric patients younger than 6 years of age with type 1 diabetes. LANTUS has not been studied in pediatric patients with type 2 diabetes.

Based on the results of a study in pediatric patients, the dose recommendation when switching to LANTUS is the same as that described for adults [see DOSAGE AND ADMINISTRATION and Clinical Studies]. As in adults, the dosage of LANTUS must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.

Geriatric Use

In controlled clinical studies comparing LANTUS to NPH insulin, 593 of 3890 patients (15%) with type 1 and type 2 diabetes were ≥ 65 years of age and 80 (2%) patients were ≥ 75 years of age. The only difference in safety or effectiveness in the subpopulation of patients ≥ 65 years of age compared to the entire study population was a higher incidence of cardiovascular events typically seen in an older population in both LANTUS and NPH insulin-treated patients. Nevertheless, caution should be exercised when LANTUS is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly [See WARNINGS AND PRECAUTIONS].

This monograph has been modified to include the generic and brand name in many instances.

OverDose

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia.

ContrainDications

LANTUS is contraindicated in patients with hypersensitivity to LANTUS or one of its excipients.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

Pharmacodynamics

Insulin glargine is a human insulin analog that has been designed to have low aqueous solubility at neutral pH. At pH 4, as in the LANTUS injection solution, insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as a basal insulin.

In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as that for human insulin. In euglycemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than NPH insulin. The effect profile of insulin glargine was relatively constant with no pronounced peak and the duration of its effect was prolonged compared to NPH insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after the injection. The median time between injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to > 24.0 hours) (24 hours was the end of the observation period) for insulin glargine.

Figure 1: Activity Profile in Patients with Type 1 Diabetes

View Enlarged Table

* Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values); indicative of insulin activity.

The longer duration of action (up to 24 hours) of LANTUS is directly related to its slower rate of absorption and supports once-daily subcutaneous administration. The time course of action of insulins, including LANTUS, may vary between individuals and within the same individual.

Pharmacokinetics

Absorption and Bioavailability

After subcutaneous injection of insulin glargine in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin. Serum insulin concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. After subcutaneous injection of 0.3 Units/kg insulin glargine in patients with type 1 diabetes, a relatively constant concentration/time profile has been demonstrated. The duration of action after abdominal, deltoid, or thigh subcutaneous administration was similar.

Metabolism

A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30BThr-insulin). Unchanged drug and these degradation products are also present in the circulation.

Special Populations

Age, Race, and Gender. Information on the effect of age, race, and gender on the pharmacokinetics of LANTUS is not available. However, in controlled clinical trials in adults (n=3890) and a controlled clinical trial in pediatric patients (n=349), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy between insulin glargine and NPH insulin [see Clinical Studies].

Smoking. The effect of smoking on the pharmacokinetics/pharmacodynamics of LANTUS has not been studied.

Pregnancy. The effect of pregnancy on the pharmacokinetics and pharmacodynamics of LANTUS has not been studied [see Use in Specific Populations].

Obesity. In controlled clinical trials, which included patients with Body Mass Index (BMI) up to and including 49.6 kg/m², subgroup analyses based on BMI did not show differences in safety and efficacy between insulin glargine and NPH insulin [see Clinical Studies].

Renal Impairment. The effect of renal impairment on the pharmacokinetics of LANTUS has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Careful glucose monitoring and dose adjustments of insulin, including LANTUS, may be necessary in patients with renal impairment [See WARNINGS AND PRECAUTIONS].

Hepatic Impairment. The effect of hepatic impairment on the pharmacokinetics of LANTUS has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure. Careful glucose monitoring and dose adjustments of insulin, including LANTUS, may be necessary in patients with hepatic impairment [See WARNINGS AND PRECAUTIONS].

Clinical Studies

The safety and effectiveness of LANTUS given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of 2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus (see Tables 8-11). In general, the reduction in glycated hemoglobin (HbA1c) with LANTUS was similar to that with NPH insulin. The overall rates of hypoglycemia did not differ between patients with diabetes treated with LANTUS compared to NPH insulin [See ADVERSE REACTIONS].

Type 1 Diabetes–Adult (see Table 8).

In two clinical studies (Studies A and B), patients with type 1 diabetes (Study A; n=585, Study B; n=534) were randomized to 28 weeks of basal-bolus treatment with LANTUS or NPH insulin. Regular human insulin was administered before each meal. LANTUS was administered at bedtime. NPH insulin was administered once daily at bedtime or in the morning and at bedtime when used twice daily.

In another clinical study (Study C), patients with type 1 diabetes (n=619) were randomized to 16 weeks of basal-bolus treatment with LANTUS or NPH insulin. Insulin lispro was used before each meal. LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily.

In these 3 studies, LANTUS and NPH insulin had similar effects on HbA1c (Table 8) with a similar overall rate of hypoglycemia [See ADVERSE REACTIONS].

Table 8: Type 1 Diabetes Mellitus–Adult

Treatment duration Treatment in combination with Study A Study B Study C
28 weeks Regular insulin 28 weeks Regular insulin 16 weeks Insulin lispro
LANTUS NPH LANTUS NPH LANTUS NPH
Number of subjects treated 292 293 264 270 310 309
HbA1c
  Baseline HbA1c 8.0 8.0 7.7 7.7 7.6 7.7
  Adj. mean change from baseline +0.2 +0.1 -0.2 -0.2 -0.1 -0.1
    LANTUS - NPH +0.1   +0.1     0.0
    95% CI for Treatment difference (0.0; +0.2)   (-0.1; +0.2)   ( ?0.1; +0.1)
Basal insulin dose
  Baseline mean 21 23 29 29 28 28
  Mean change from baseline -2 0 -4 +2 -5 +1
Total insulin dose
  Baseline mean 48 52 50 51 50 50
  Mean change from baseline -1 0 0 +4 -3 0
Fasting blood glucose (mg/dL)
  Baseline mean 167 166 166 175 175 173
  Adj. mean change from baseline -21 -16 -20 -17 -29 -12
Body weight (kg)
  Baseline mean 73.2 74.8 75.5 75.0 74.8 75.6
  Mean change from baseline 0.1 -0.0 0.7 1.0 0.1 0.5
Type 1 Diabetes–Pediatric (see Table 9).

In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily. Similar effects on HbA1c (Table 9) and the incidence of hypoglycemia were observed in both treatment groups [See ADVERSE REACTIONS].

Table 9: Type 1 Diabetes Mellitus–Pediatric

Treatment duration Treatment in combination with Study D 28 weeks Regular insulin
LANTUS NPH
Number of subjects treated 174 175
HbA1c
  Baseline mean 8.5 8.8
  Adj. mean change from baseline +0.3 +0.3
     LANTUS - NPH 0.0
     95% CI for Treatment difference (-0.2; +0.3)
Basal insulin dose
  Baseline mean 19 19
  Mean change from baseline -1 +2
Total insulin dose
  Baseline mean 43 43
  Mean change from baseline +2 +3
Fasting blood glucose (mg/dL)
  Baseline mean 194 191
 Adj. mean change from baseline -23 -12
Body weight (kg)
  Baseline mean 45.5 44.6
  Mean change from baseline 2.2 2.5
Type 2 Diabetes–Adult (see Table 10).

In a randomized, controlled clinical study (Study E) (n=570), LANTUS was evaluated for 52 weeks in combination with oral anti-diabetic medications (a sulfonylurea, metformin, acarbose, or combinations of these drugs). LANTUS administered once daily at bedtime was as effective as NPH insulin administered once daily at bedtime in reducing HbA1c and fasting glucose (Table 10). The rate of hypoglycemia was similar in LANTUS and NPH insulin treated patients [See ADVERSE REACTIONS].

In a randomized, controlled clinical study (Study F), in patients with type 2 diabetes not using oral anti-diabetic medications (n=518), a basal-bolus regimen of LANTUS once daily at bedtime or NPH insulin administered once or twice daily was evaluated for 28 weeks. Regular human insulin was used before meals, as needed. LANTUS had similar effectiveness as either once- or twice-daily NPH insulin in reducing HbA1c and fasting glucose (Table 10) with a similar incidence of hypoglycemia [See ADVERSE REACTIONS].

In a randomized, controlled clinical study (Study G), patients with type 2 diabetes were randomized to 5 years of treatment with once-daily LANTUS or twice-daily NPH insulin. For patients not previously treated with insulin, the starting dose of LANTUS or NPH insulin was 10 units daily. Patients who were already treated with NPH insulin either continued on the same total daily NPH insulin dose or started LANTUS at a dose that was 80% of the total previous NPH insulin dose. The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. HbA1c change from baseline was a secondary endpoint. Similar glycemic control in the 2 treatment groups was desired in order to not confound the interpretation of the retinal data. Patients or study personnel used an algorithm to adjust the LANTUS and NPH insulin doses to a target fasting plasma glucose ≤ 100 mg/dL. After the LANTUS or NPH insulin dose was adjusted, other anti-diabetic agents, including pre-meal insulin were to be adjusted or added. The LANTUS group had a smaller mean reduction from baseline in HbA1c compared to the NPH insulin group, which may be explained by the lower daily basal insulin doses in the LANTUS group (Table 10). Both treatment groups had a similar incidence of reported symptomatic hypoglycemia. The incidences of severe symptomatic hypoglycemia are given in Table 6 [See ADVERSE REACTIONS].

Table 10: Type 2 Diabetes Mellitus–Adult

Treatment duration Treatment in combination with Study E Study F Study G
52 weeks Oral agents 28 weeks Regular insulin 5 years Regular insulin
LANTUS NPH LANTUS NPH LANTUS NPH
Number of subjects treated 289 281 259 259 513 504
HbA1c
  Baseline mean 9.0 8.9 8.6 8.5 8.4 8.3
  Adj. mean change from baseline -0.5 -0.4 -0.4 -0.6 -0.6 -0.8
    LANTUS - NPH -0.1 +0.2 +0.2
    95% CI for Treatment difference (-0.3; +0.1) (0.0; +0.4) (+0.1, +0.4)
Basal insulin dose*
  Baseline mean 14 15 44.1 45.5 39 44
  Mean change from baseline +12 +9 -1 +7 +23 +30
Total insulin dose*
  Baseline mean 14 15 64 67 48 53
  Mean change from baseline +12 +9 +10 +13 +41 +40
Fasting blood glucose (mg/dL)
  Baseline mean 179 180 164 166 190 180
  Adj. mean change from baseline -49 -46 -24 -22 -45 -44
Body weight (kg)
  Baseline mean 83.5 82.1 89.6 90.7 100 99
  Adj. mean change from baseline 2.0 1.9 0.4 1.4 3.7 4.8
*In Study G, the baseline dose of basal or total insulin was the first available on-treatment dose prescribed during the study (on visit month 1.5).
LANTUS Timing of Daily Dosing (see Table 11).

The safety and efficacy of LANTUS administered pre-breakfast, pre-dinner, or at bedtime were evaluated in a randomized, controlled clinical study in patients with type 1 diabetes (study H, n=378). Patients were also treated with insulin lispro at mealtime. LANTUS administered at different times of the day resulted in similar reductions in HbA1c compared to that with bedtime administration (see Table 11). In these patients, data are available from 8-point home glucose monitoring. The maximum mean blood glucose was observed just prior to injection of LANTUS regardless of time of administration.

In this study, 5% of patients in the LANTUS-breakfast arm discontinued treatment because of lack of efficacy. No patients in the other two arms discontinued for this reason. The safety and efficacy of LANTUS administered pre-breakfast or at bedtime were also evaluated in a randomized, active-controlled clinical study (Study I, n=697) in patients with type 2 diabetes not adequately controlled on oral anti-diabetic therapy. All patients in this study also received glimepiride 3 mg daily. LANTUS given before breakfast was at least as effective in lowering HbA1c as LANTUS given at bedtime or NPH insulin given at bedtime (see Table 11).

Table 11: LANTUS Timing of Daily Dosing in Type 1 (Study H) and Type 2 (Study I) Diabetes Mellitus

View Enlarged Table

Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.

Mechanism of Action

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

Pharmacodynamics

Insulin glargine is a human insulin analog that has been designed to have low aqueous solubility at neutral pH. At pH 4, as in the LANTUS injection solution, insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as a basal insulin.

In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as that for human insulin. In euglycemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than NPH insulin. The effect profile of insulin glargine was relatively constant with no pronounced peak and the duration of its effect was prolonged compared to NPH insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after the injection. The median time between injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to > 24.0 hours) (24 hours was the end of the observation period) for insulin glargine.

Figure 1: Activity Profile in Patients with Type 1 Diabetes

View Enlarged Table

* Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values); indicative of insulin activity.

The longer duration of action (up to 24 hours) of LANTUS is directly related to its slower rate of absorption and supports once-daily subcutaneous administration. The time course of action of insulins, including LANTUS, may vary between individuals and within the same individual.

Pharmacokinetics

Absorption and Bioavailability

After subcutaneous injection of insulin glargine in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin. Serum insulin concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. After subcutaneous injection of 0.3 Units/kg insulin glargine in patients with type 1 diabetes, a relatively constant concentration/time profile has been demonstrated. The duration of action after abdominal, deltoid, or thigh subcutaneous administration was similar.

Metabolism

A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30BThr-insulin). Unchanged drug and these degradation products are also present in the circulation.

Special Populations

Age, Race, and Gender. Information on the effect of age, race, and gender on the pharmacokinetics of LANTUS is not available. However, in controlled clinical trials in adults (n=3890) and a controlled clinical trial in pediatric patients (n=349), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy between insulin glargine and NPH insulin [see Clinical Studies].

Smoking. The effect of smoking on the pharmacokinetics/pharmacodynamics of LANTUS has not been studied.

Pregnancy. The effect of pregnancy on the pharmacokinetics and pharmacodynamics of LANTUS has not been studied [see Use in Specific Populations].

Obesity. In controlled clinical trials, which included patients with Body Mass Index (BMI) up to and including 49.6 kg/m², subgroup analyses based on BMI did not show differences in safety and efficacy between insulin glargine and NPH insulin [see Clinical Studies].

Renal Impairment. The effect of renal impairment on the pharmacokinetics of LANTUS has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Careful glucose monitoring and dose adjustments of insulin, including LANTUS, may be necessary in patients with renal impairment [See WARNINGS AND PRECAUTIONS].

Hepatic Impairment. The effect of hepatic impairment on the pharmacokinetics of LANTUS has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure. Careful glucose monitoring and dose adjustments of insulin, including LANTUS, may be necessary in patients with hepatic impairment [See WARNINGS AND PRECAUTIONS].

Clinical Studies

The safety and effectiveness of LANTUS given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of 2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus (see Tables 8-11). In general, the reduction in glycated hemoglobin (HbA1c) with LANTUS was similar to that with NPH insulin. The overall rates of hypoglycemia did not differ between patients with diabetes treated with LANTUS compared to NPH insulin [See ADVERSE REACTIONS].

Type 1 Diabetes–Adult (see Table 8).

In two clinical studies (Studies A and B), patients with type 1 diabetes (Study A; n=585, Study B; n=534) were randomized to 28 weeks of basal-bolus treatment with LANTUS or NPH insulin. Regular human insulin was administered before each meal. LANTUS was administered at bedtime. NPH insulin was administered once daily at bedtime or in the morning and at bedtime when used twice daily.

In another clinical study (Study C), patients with type 1 diabetes (n=619) were randomized to 16 weeks of basal-bolus treatment with LANTUS or NPH insulin. Insulin lispro was used before each meal. LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily.

In these 3 studies, LANTUS and NPH insulin had similar effects on HbA1c (Table 8) with a similar overall rate of hypoglycemia [See ADVERSE REACTIONS].

Table 8: Type 1 Diabetes Mellitus–Adult

Treatment duration Treatment in combination with Study A Study B Study C
28 weeks Regular insulin 28 weeks Regular insulin 16 weeks Insulin lispro
LANTUS NPH LANTUS NPH LANTUS NPH
Number of subjects treated 292 293 264 270 310 309
HbA1c
  Baseline HbA1c 8.0 8.0 7.7 7.7 7.6 7.7
  Adj. mean change from baseline +0.2 +0.1 -0.2 -0.2 -0.1 -0.1
    LANTUS - NPH +0.1   +0.1     0.0
    95% CI for Treatment difference (0.0; +0.2)   (-0.1; +0.2)   ( ?0.1; +0.1)
Basal insulin dose
  Baseline mean 21 23 29 29 28 28
  Mean change from baseline -2 0 -4 +2 -5 +1
Total insulin dose
  Baseline mean 48 52 50 51 50 50
  Mean change from baseline -1 0 0 +4 -3 0
Fasting blood glucose (mg/dL)
  Baseline mean 167 166 166 175 175 173
  Adj. mean change from baseline -21 -16 -20 -17 -29 -12
Body weight (kg)
  Baseline mean 73.2 74.8 75.5 75.0 74.8 75.6
  Mean change from baseline 0.1 -0.0 0.7 1.0 0.1 0.5
Type 1 Diabetes–Pediatric (see Table 9).

In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily. Similar effects on HbA1c (Table 9) and the incidence of hypoglycemia were observed in both treatment groups [See ADVERSE REACTIONS].

Table 9: Type 1 Diabetes Mellitus–Pediatric

Treatment duration Treatment in combination with Study D 28 weeks Regular insulin
LANTUS NPH
Number of subjects treated 174 175
HbA1c
  Baseline mean 8.5 8.8
  Adj. mean change from baseline +0.3 +0.3
     LANTUS - NPH 0.0
     95% CI for Treatment difference (-0.2; +0.3)
Basal insulin dose
  Baseline mean 19 19
  Mean change from baseline -1 +2
Total insulin dose
  Baseline mean 43 43
  Mean change from baseline +2 +3
Fasting blood glucose (mg/dL)
  Baseline mean 194 191
 Adj. mean change from baseline -23 -12
Body weight (kg)
  Baseline mean 45.5 44.6
  Mean change from baseline 2.2 2.5
Type 2 Diabetes–Adult (see Table 10).

In a randomized, controlled clinical study (Study E) (n=570), LANTUS was evaluated for 52 weeks in combination with oral anti-diabetic medications (a sulfonylurea, metformin, acarbose, or combinations of these drugs). LANTUS administered once daily at bedtime was as effective as NPH insulin administered once daily at bedtime in reducing HbA1c and fasting glucose (Table 10). The rate of hypoglycemia was similar in LANTUS and NPH insulin treated patients [See ADVERSE REACTIONS].

In a randomized, controlled clinical study (Study F), in patients with type 2 diabetes not using oral anti-diabetic medications (n=518), a basal-bolus regimen of LANTUS once daily at bedtime or NPH insulin administered once or twice daily was evaluated for 28 weeks. Regular human insulin was used before meals, as needed. LANTUS had similar effectiveness as either once- or twice-daily NPH insulin in reducing HbA1c and fasting glucose (Table 10) with a similar incidence of hypoglycemia [See ADVERSE REACTIONS].

In a randomized, controlled clinical study (Study G), patients with type 2 diabetes were randomized to 5 years of treatment with once-daily LANTUS or twice-daily NPH insulin. For patients not previously treated with insulin, the starting dose of LANTUS or NPH insulin was 10 units daily. Patients who were already treated with NPH insulin either continued on the same total daily NPH insulin dose or started LANTUS at a dose that was 80% of the total previous NPH insulin dose. The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. HbA1c change from baseline was a secondary endpoint. Similar glycemic control in the 2 treatment groups was desired in order to not confound the interpretation of the retinal data. Patients or study personnel used an algorithm to adjust the LANTUS and NPH insulin doses to a target fasting plasma glucose ≤ 100 mg/dL. After the LANTUS or NPH insulin dose was adjusted, other anti-diabetic agents, including pre-meal insulin were to be adjusted or added. The LANTUS group had a smaller mean reduction from baseline in HbA1c compared to the NPH insulin group, which may be explained by the lower daily basal insulin doses in the LANTUS group (Table 10). Both treatment groups had a similar incidence of reported symptomatic hypoglycemia. The incidences of severe symptomatic hypoglycemia are given in Table 6 [See ADVERSE REACTIONS].

Table 10: Type 2 Diabetes Mellitus–Adult

Treatment duration Treatment in combination with Study E Study F Study G
52 weeks Oral agents 28 weeks Regular insulin 5 years Regular insulin
LANTUS NPH LANTUS NPH LANTUS NPH
Number of subjects treated 289 281 259 259 513 504
HbA1c
  Baseline mean 9.0 8.9 8.6 8.5 8.4 8.3
  Adj. mean change from baseline -0.5 -0.4 -0.4 -0.6 -0.6 -0.8
    LANTUS - NPH -0.1 +0.2 +0.2
    95% CI for Treatment difference (-0.3; +0.1) (0.0; +0.4) (+0.1, +0.4)
Basal insulin dose*
  Baseline mean 14 15 44.1 45.5 39 44
  Mean change from baseline +12 +9 -1 +7 +23 +30
Total insulin dose*
  Baseline mean 14 15 64 67 48 53
  Mean change from baseline +12 +9 +10 +13 +41 +40
Fasting blood glucose (mg/dL)
  Baseline mean 179 180 164 166 190 180
  Adj. mean change from baseline -49 -46 -24 -22 -45 -44
Body weight (kg)
  Baseline mean 83.5 82.1 89.6 90.7 100 99
  Adj. mean change from baseline 2.0 1.9 0.4 1.4 3.7 4.8
*In Study G, the baseline dose of basal or total insulin was the first available on-treatment dose prescribed during the study (on visit month 1.5).
LANTUS Timing of Daily Dosing (see Table 11).

The safety and efficacy of LANTUS administered pre-breakfast, pre-dinner, or at bedtime were evaluated in a randomized, controlled clinical study in patients with type 1 diabetes (study H, n=378). Patients were also treated with insulin lispro at mealtime. LANTUS administered at different times of the day resulted in similar reductions in HbA1c compared to that with bedtime administration (see Table 11). In these patients, data are available from 8-point home glucose monitoring. The maximum mean blood glucose was observed just prior to injection of LANTUS regardless of time of administration.

In this study, 5% of patients in the LANTUS-breakfast arm discontinued treatment because of lack of efficacy. No patients in the other two arms discontinued for this reason. The safety and efficacy of LANTUS administered pre-breakfast or at bedtime were also evaluated in a randomized, active-controlled clinical study (Study I, n=697) in patients with type 2 diabetes not adequately controlled on oral anti-diabetic therapy. All patients in this study also received glimepiride 3 mg daily. LANTUS given before breakfast was at least as effective in lowering HbA1c as LANTUS given at bedtime or NPH insulin given at bedtime (see Table 11).

Table 11: LANTUS Timing of Daily Dosing in Type 1 (Study H) and Type 2 (Study I) Diabetes Mellitus

View Enlarged Table

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

LANTUS® SOLOSTAR® 3 mL disposable insulin delivery device (300 units per device) 100 units per mL (U-100) (insulin glargine [recombinant DNA origin] injection)

What is the most important information I should know about LANTUS?

  • What is LANTUS?
  • Who should NOT take LANTUS?
  • How should I use LANTUS?
  • Mixing with LANTUS
  • Instructions for Use
  • What can affect how much insulin I need?
  • What are the possible side effects of LANTUS and other insulins?
  • How should I store LANTUS?
  • General Information about LANTUS

Read this “Patient Information” that comes with LANTUS (LAN-tus) before you start using it and each time you get a refill because there may be new information. This leaflet does not take the place of talking with your healthcare provider about your condition or treatment. If you have questions about LANTUS or about diabetes, talk with your healthcare provider.

What is the most important information I should know about LANTUS?

  • Do not change the insulin you are using without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork, beef-pork, human) or method of manufacture (recombinant DNA versus animal-source insulin) may need a change in the dose. This dose change may be needed right away or later on during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed.
  • You must test your blood sugar levels while using an insulin, such as LANTUS. Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
  • Do NOT dilute or mix LANTUS with any other insulin or solution. It will not work and you may lose blood sugar control, which could be serious.
  • LANTUS comes as U-100 insulin and contains 100 units of LANTUS per milliliter (mL). One milliliter of U-100 insulin contains 100 units of insulin. (1 mL = 1 cc).

What is Diabetes?

  • Your body needs insulin to turn sugar (glucose) into energy. If your body does not make enough insulin, you need to take more insulin so you will not have too much sugar in your blood.
  • Insulin injections are important in keeping your diabetes under control. But the way you live, your diet, careful checking of your blood sugar levels, exercise, and planned physical activity, all work with your insulin to help you control your diabetes.

What is LANTUS?

  • LANTUS (insulin glargine [recombinant DNA origin]) is a long-acting insulin. . Because Lantus is made by recombinant DNA technology (rDNA) and is chemically different from the insulin made by the human body, it is called an insulin analog. LANTUS is used to treat patients with diabetes for the control of high blood sugar. It is used once a day to lower blood glucose.
  • LANTUS is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
  • The active ingredient in LANTUS is insulin glargine. The concentration of insulin glargine is 100 units per milliliter (mL), or U-100. LANTUS also contains zinc, metacresol, glycerol, and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
  • You need a prescription to get LANTUS. Always be sure you receive the right insulin from the pharmacy.

Who should NOT take LANTUS?

Do not take LANTUS if you are allergic to insulin glargine or any of the inactive ingredients in LANTUS. Check with your healthcare provider if you are not sure.

  • Before starting LANTUS, tell your healthcare provider about all your medical conditions including if you:
    • have liver or kidney problems. Your dose may need to be adjusted.
    • are pregnant or plan to become pregnant. It is not known if LANTUS may harm your unborn baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your healthcare provider will decide which insulin is best for you during your pregnancy.
    • are breast-feeding or plan to breast-feed. It is not known whether LANTUS passes into your milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk to your healthcare provider about the best way to feed your baby.
    • are taking any other medicines including prescription and non-prescription medicines, vitamins and herbal supplements.

How should I use LANTUS?

See the “Instructions for SoloStar® Use” section for additional information.

  • Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.
  • You may take LANTUS at any time during the day but you must take it at the same time every day.
  • Only use LANTUS that is clear and colorless. If your LANTUS is cloudy or slightly colored, return it to your pharmacy for a replacement.
  • Follow your healthcare provider's instructions for testing your blood sugar.
  • Inject LANTUS under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
  • Change (rotate) injection sites within the same body area.
  • NEEDLES AND SOLOSTAR® MUST NOT BE SHARED.
  • Disposable needles should be used only once. Used needle should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

Mixing with LANTUS

  • Do NOT dilute or mix LANTUS with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious.

Instructions for SoloStar® Use

It is important to read, understand, and follow the step-by-step instructions in the “SoloStar® Instruction Leaflet” before using SoloStar® disposable insulin Pen. Failure to follow the instructions may result in getting too much or too little insulin. If you have lost your leaflet or have a question, go to www.lantus.com or call 1-800-633-1610.

The following general notes should be taken into consideration before injecting Lantus:

  • Always wash your hands before handling the SoloStar® disposable insulin Pen.
  • Always attach a new needle before use. BD Ultra-Fine™ needles† are compatible with SoloStar. These are sold separately and are manufactured by BD.
  • Always perform the safety test before use.
  • Check the insulin solution in the pen to make sure it is clear, colorless, and free of particles. If it is not, throw it away.
  • Do NOT mix or dilute LANTUS with any other insulin or solution. LANTUS will not work if it is mixed or diluted and you may lose blood sugar control, which could be serious.

Decide on an injection area - either upper arm, thigh, or abdomen. Do not use the same injection site as your last injection.

After injecting LANTUS, leave the needle in the skin for an additional 10 seconds. Then pull the needle straight out. Gently press on the spot where you injected yourself for a few seconds. Do not rub the area.

Do not drop the SoloStar® disposable insulin Pen.

If your blood glucose reading is high or low, tell your healthcare provider so the dose can be adjusted.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you need. It is a good idea to think ahead and make a ”sick day” plan with your healthcare provider in advance so you will be ready when this happens. Be sure to test your blood sugar more often and call your healthcare provider if you are sick.

Medicines. Many medicines can affect your insulin needs. Other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements, can change the way insulin works. You may need a different dose of insulin when you are taking certain other medicines. Know all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. You may want to keep a list of the medicines you take. You can show this list to your healthcare provider and pharmacists anytime you get a new medicine or refill. Your healthcare provider will tell you if your insulin dose needs to be changed.

Meals. The amount of food you eat can affect your insulin needs. If you eat less food, skip meals, or eat more food than usual, you may need a different dose of insulin. Talk to your healthcare provider if you change your diet so that you know how to adjust your LANTUS and other insulin doses.

Alcohol. Alcohol, including beer and wine, may affect the way LANTUS works and affect your blood sugar levels. Talk to your healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity level may change the way your body uses insulin. Check with your healthcare provider before you start an exercise program because your dose may need to be changed.

Travel. If you travel across time zones, talk with your healthcare provider about how to time your injections. When you travel, wear your medical alert identification. Take extra insulin and supplies with you.

Pregnancy or nursing. The effects of LANTUS on an unborn child or on a nursing baby are unknown. Therefore, tell your healthcare provider if you planning to have a baby, are pregnant, or nursing a baby. Good control of diabetes is especially important during pregnancy and nursing.

What are the possible side effects of LANTUS and other insulins?

Insulins, including LANTUS, can cause hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergy, and skin reactions.

Hypoglycemia (low blood sugar):

Hypoglycemia is often called an “insulin reaction” or “low blood sugar”. It may happen when you do not have enough sugar in your blood. Common causes of hypoglycemia are illness, emotional or physical stress, too much insulin, too little food or missed meals, and too much exercise or activity.

Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some people. That is why it is important to check your blood sugar as you have been advised by your healthcare provider.

Hypoglycemia can happen with:

  • Taking too much insulin. This can happen when too much insulin is injected.
  • Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is missed or delayed.
  • Vomiting or diarrhea that decreases the amount of sugar absorbed by your body.
  • Intake of alcohol.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that can affect your blood sugar levels or insulin. These conditions include diseases of the adrenal glands, the pituitary, the thyroid gland, the liver, and the kidney.
  • Too much glucose use by the body. This can happen if you exercise too much or have a fever.
  • Injecting insulin the wrong way or in the wrong injection area.

Hypoglycemia can be mild to severe. Its onset may be rapid. Some patients have few or no warning symptoms, including:

  • patients with diabetes for a long time
  • patients with diabetic neuropathy (nerve problems)
  • or patients using certain medicines for high blood pressure or heart problems.

Hypoglycemia may reduce your ability to drive a car or use mechanical equipment and you may risk injury to yourself or others.

Severe hypoglycemia can be dangerous and can cause temporary or permanent harm to your heart or brain. It may cause unconsciousness, seizures, or death.

Symptoms of hypoglycemia may include:

  • anxiety, irritability, restlessness, trouble concentrating, personality changes, mood changes, or other abnormal behavior
  • tingling in your hands, feet, lips, or tongue
  • dizziness, light-headedness, or drowsiness
  • nightmares or trouble sleeping
  • headache
  • blurred vision
  • slurred speech
  • palpitations (fast heart beat)
  • sweating
  • tremor (shaking)
  • unsteady gait (walking).

If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates such as fruit juice, raisins, sugar candies, milk or glucose tablets. Talk to your healthcare provider about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another person or emergency medical people. A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth, or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intravenously (IV). Without medical help right away, serious reactions or even death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in your blood. Usually, it means there is not enough insulin to break down the food you eat into energy your body can use. Hyperglycemia can be caused by a fever, an infection, stress, eating more than you should, taking less insulin than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

  • Insufficient (too little) insulin. This can happen from:
    • injecting too little or no insulin
    • incorrect storage (freezing, excessive heat)
    • use after the expiration date.
  • Too much carbohydrate intake. This can happen if you eat larger meals, eat more often, or increase the amount of carbohydrate in your meals.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that affect insulin. These medical conditions include fevers, infections, heart attacks, and stress.
  • Injecting insulin the wrong way or in the wrong injection area.

Testing your blood or urine often will let you know if you have hyperglycemia. If your tests are often high, tell your healthcare provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. It can progress to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma) and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in patients with type 1 diabetes, it can also happen in patients with type 2 diabetes who become very sick. Because some patients get few symptoms of hyperglycemia, it is important to check your blood sugar/urine sugar and ketones regularly.

Symptoms of hyperglycemia include:

  • confusion or drowsiness
  • increased thirst
  • decreased appetite, nausea, or vomiting
  • rapid heart rate
  • increased urination and dehydration (too little fluid in your body).

Symptoms of DKA also include:

  • fruity smelling breath
  • fast, deep breathing
  • stomach area (abdominal) pain.

Severe or continuing hyperglycemia or DKA needs evaluation and treatment right away by your healthcare provider.

Do not use LANTUS to treat diabetic ketoacidosis.

Other possible side effects of LANTUS include:

Serious allergic reactions:

Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:

  • rash all over your body
  • shortness of breath
  • wheezing (trouble breathing)
  • fast pulse
  • sweating
  • low blood pressure.

Reactions at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

  • little depression in the skin (lipoatrophy)
  • skin thickening (lipohypertrophy)
  • red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site reaction if you change (rotate) the injection site each time. An injection site reaction should clear up in a few days or a few weeks. If injection site reactions do not go away or keep happening call your healthcare provider.

Tell your healthcare provider if you have any side effects that bother you.

These are not all the side effects of LANTUS. Ask your healthcare provider or pharmacist for more information.

How should I store LANTUS?

  • Unopened SoloStar®:
    Store new unopened SoloStar® disposable insulin pen in a refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze LANTUS. Keep LANTUS out of direct heat and light. If a disposable insulin pen has been frozen or overheated, throw it away.
  • Open (In-Use) SoloStar®:
    Once SoloStar® is opened (in-use), SoloStar® should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar® kept at room temperature must be discarded after 28 days.

These storage conditions are summarized in the following table:

 

  Not in-use (unopened) Refrigerated Not in-use (unopened) Room Temperature In-use (opened) Room Temperature (Do not refrigerate)
3 mL SoloStar® disposable insulindevice Until expiration date 28 days 28 days
  • Do not use SoloStar® with LANTUS after the expiration date stamped on the label.
  • Do not use LANTUS if it is cloudy, colored, or if you see particles.

General Information about LANTUS

  • Use LANTUS only to treat your diabetes. Do not give or share LANTUS with another person, even if they have diabetes also. It may harm them.
  • This leaflet summarizes the most important information about LANTUS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LANTUS that is written for healthcare professionals. For more information about LANTUS call 1-800-633-1610 or go to website www.lantus.com.

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed especially for patients with diabetes and their families and is available by subscription from the American Diabetes Association (ADA), P.O. Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the ADA website at www.diabetes.org. Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International (JDRF), 120 Wall Street, 19th Floor, New York, New York 10005, 1800-JDF-CURE (1-800-533-2873). You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your healthcare professional or diabetes educator or visit www.DiabetesWatch.com.

Additional information about LANTUS can be obtained by calling 1-800-633-1610 or by visiting www.lantus.com.

LANTUS® 10 mL vial (1000 units per vial) 100 units per mL (U-100) (insulin glargine [recombinant DNA origin] injection)

What is the most important information I should know about LANTUS?

  • What is LANTUS?
  • Who should NOT take LANTUS?
  • How should I use LANTUS?
  • What kind of syringe should I use?
  • Mixing with LANTUS
  • Instructions for Use
    • How do I draw the insulin into the syringe?
    • How do I inject LANTUS?
  • What can affect how much insulin I need?
  • What are the possible side effects of LANTUS and other insulins?
  • How should I store LANTUS?
  • General Information about LANTUS

Read this “Patient Information” that comes with LANTUS (LAN-tus) before you start using it and each time you get a refill because there may be new information. This leaflet does not take the place of talking with your healthcare provider about your condition or treatment. If you have questions about LANTUS or about diabetes, talk with your healthcare provider.

What is the most important information I should know about LANTUS?

  • Do not change the insulin you are using without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork, beef-pork, human) or method of manufacture (recombinant DNA versus animal source insulin) may need a change in the dose. This dose change may be needed right away or later on during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed.
  • You must test your blood sugar levels while using an insulin, such as LANTUS. Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
  • Do NOT dilute or mix LANTUS with any other insulin or solution. It will not work and you may lose blood sugar control, which could be serious.
  • LANTUS comes as U-100 insulin and contains 100 units of LANTUS per milliliter (mL). One milliliter of U-100 insulin contains 100 units of insulin. (1 mL = 1 cc).

What is Diabetes?

  • Your body needs insulin to turn sugar (glucose) into energy. If your body does not make enough insulin, you need to take more insulin so you will not have too much sugar in your blood.
  • Insulin injections are important in keeping your diabetes under control. But the way you live, your diet, careful checking of your blood sugar levels, exercise, and planned physical activity, all work with your insulin to help you control your diabetes.

What is LANTUS?

  • LANTUS (insulin glargine [recombinant DNA origin]) is a long-acting insulin. Because LANTUS is made by recombinant DNA technology (rDNA) and is chemically different from the insulin made by the human body, it is called an insulin analog. LANTUS is used to treat patients with diabetes for the control of high blood sugar. It is used once a day to lower blood sugar.
  • LANTUS is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
  • The active ingredient in LANTUS is insulin glargine. The concentration of insulin glargine is 100 units per milliliter (mL), or U-100. LANTUS also contains zinc, metacresol, glycerol, polysorbate 20 and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
  • You need a prescription to get LANTUS. Always be sure you receive the right insulin from the pharmacy. The carton and vial should look like the ones in this picture.

 

LANTUS (insulin glargine [rDNA origin] injection) - Illustration

Who should NOT take LANTUS?

Do not take LANTUS if you are allergic to insulin glargine or any of the inactive ingredients in LANTUS. Check with your healthcare provider if you are not sure.

Before starting LANTUS, tell your healthcare provider about all your medical conditions including if you:

    • have liver or kidney problems. Your dose may need to be adjusted.
    • are pregnant or plan to become pregnant. It is not known if LANTUS may harm your unborn baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your healthcare provider will decide which insulin is best for you during your pregnancy.
    • are breast-feeding or plan to breast-feed. It is not known whether LANTUS passes into your milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk to your healthcare provider about the best way to feed your baby.
  • about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

How should I use LANTUS?

See the “Instructions for Use” including the “How do I draw the insulin into the syringe?” section for additional information.

  • Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.
  • You may take LANTUS at any time during the day but you must take it at the same time every day.
  • Only use LANTUS that is clear and colorless. If your LANTUS is cloudy or slightly colored, return it to your pharmacy for a replacement.
  • Follow your healthcare provider's instructions for testing your blood sugar.
  • Inject LANTUS under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
  • Change (rotate) injection sites within the same body area.

What kind of syringe should I use?

  • Always use a syringe that is marked for U-100 insulin. If you use other than U-100 insulin syringe, you may get the wrong dose of insulin causing serious problems for you, such as a blood sugar level that is too low or too high. Always use a new needle and syringe each time you give LANTUS injection.
  • NEEDLES AND SYRINGES MUST NOT BE SHARED.
  • Disposable syringes and needles should be used only once. Used syringe and needle should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

Mixing with LANTUS

  • Do NOT dilute or mix LANTUS with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious.

Instructions for Use

How do I draw the insulin into the syringe?

  • The syringe must be new and does not contain any other medicine.
  • Do not mix LANTUS with any other type of insulin.

Follow these steps:

1. Wash your hands with soap and water or with alcohol.

2. Check the insulin to make sure it is clear and colorless. Do not use the insulin after the expiration date stamped on the label, if it is colored or cloudy, or if you see particles in the solution.

3. If you are using a new vial, remove the protective cap. Do not remove the stopper.

 

Remove the protective cap - Illustration

4. Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of LANTUS before use.

 

Wipe the top - Illustration

5. Use a new needle and syringe every time you give an injection. Use disposable syringes and needles only once. Throw them away properly. Never share needles and syringes.

6. Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

 

Draw air into the syringe equal to your insulin dose - Illustration

7. Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand.

8. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe.

 

pull the plunger to withdraw the correct dose - Illustration

9. Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose.

 

tap the side of the syringe - Illustration

10. Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

How do I inject LANTUS?

Inject LANTUS under your skin. Take LANTUS as prescribed by your healthcare provider.

Follow these steps:

1. Decide on an injection area - either upper arm, thigh or abdomen. Injection sites within an injection area must be different from one injection to the next.

2. Use alcohol or soap and water to clean the injection site. The injection site should be dry before you inject.

 

Clean the injection site - Illustration

3. Pinch the skin. Stick the needle in the way your healthcare provider showed you. Release the skin.

4. Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin. Leave the needle in the skin for about 10 seconds.

 

Inject all of the medicine - Illustration

5. Pull the needle straight out and gently press on the spot where you injected yourself for several seconds. Do not rub the area.

6. Follow your healthcare provider's instructions for throwing away the used needle and syringe. Do not recap the used needle. Used needle and syringe should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you need. It is a good idea to think ahead and make a “sick day” plan with your healthcare provider in advance so you will be ready when this happens. Be sure to test your blood sugar more often and call your healthcare provider if you are sick.

Medicines. Many medicines can affect your insulin needs. Other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements, can change the way insulin works. You may need a different dose of insulin when you are taking certain other medicines. Know all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. You may want to keep a list of the medicines you take. You can show this list to your healthcare provider anytime you get a new medicine or refill. Your healthcare provider will tell you if your insulin dose needs to be changed.

Meals. The amount of food you eat can affect your insulin needs. If you eat less food, skip meals, or eat more food than usual, you may need a different dose of insulin. Talk to your healthcare provider if you change your diet so that you know how to adjust your LANTUS and other insulin doses.

Alcohol. Alcohol, including beer and wine, may affect the way LANTUS works and affect your blood sugar levels. Talk to your healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity level may change the way your body uses insulin. Check with your healthcare provider before you start an exercise program because your dose may need to be changed.

Travel. If you travel across time zones, talk with your healthcare provider about how to time your injections. When you travel, wear your medical alert identification. Take extra insulin and supplies with you.

Pregnancy or nursing. The effects of LANTUS on an unborn child or on a nursing baby are unknown. Therefore, tell your healthcare provider if you planning to have a baby, are pregnant, or nursing a baby. Good control of diabetes is especially important during pregnancy and nursing.

What are the possible side effects of LANTUS and other insulins?

Insulins, including LANTUS, can cause hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergy, and skin reactions.

Hypoglycemia (low blood sugar):

Hypoglycemia is often called an “insulin reaction” or “low blood sugar”. It may happen when you do not have enough sugar in your blood. Common causes of hypoglycemia are illness, emotional or physical stress, too much insulin, too little food or missed meals, and too much exercise or activity. Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some people. That is why it is important to check your blood sugar as you have been advised by your healthcare provider.

Hypoglycemia can happen with:

  • Taking too much insulin. This can happen when too much insulin is injected.
  • Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is missed or delayed.
  • Vomiting or diarrhea that decreases the amount of sugar absorbed by your body.
  • Intake of alcohol.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that can affect your blood sugar levels or insulin. These conditions include diseases of the adrenal glands, the pituitary, the thyroid gland, the liver, and the kidney.
  • Too much glucose use by the body. This can happen if you exercise too much or have a fever.
  • Injecting insulin the wrong way or in the wrong injection area.

Hypoglycemia can be mild to severe. Its onset may be rapid. Some patients have few or no warning symptoms, including:

  • patients with diabetes for a long time
  • patients with diabetic neuropathy (nerve problems)
  • or patients using certain medicines for high blood pressure or heart problems.

Hypoglycemia may reduce your ability to drive a car or use mechanical equipment and you may risk injury to yourself or others.

Severe hypoglycemia can be dangerous and can cause temporary or permanent harm to your heart or brain. It may cause unconsciousness, seizures, or death.

Symptoms of hypoglycemia may include:

  • anxiety, irritability, restlessness, trouble concentrating, personality changes, mood changes, or other abnormal behavior
  • tingling in your hands, feet, lips, or tongue
  • dizziness, light-headedness, or drowsiness
  • nightmares or trouble sleeping
  • headache
  • blurred vision
  • slurred speech
  • palpitations (fast heart beat)
  • sweating
  • tremor (shaking)
  • unsteady gait (walking).

If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates, such as fruit juice, raisins, sugar candies, milk or glucose tablets. Talk to your healthcare provider about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another person or emergency medical people. A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth, or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intravenously (IV). Without medical help right away, serious reactions or even death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in your blood. Usually, it means there is not enough insulin to break down the food you eat into energy your body can use. Hyperglycemia can be caused by a fever, an infection, stress, eating more than you should, taking less insulin than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

  • Insufficient (too little) insulin. This can happen from:
    • injecting too little or no insulin
    • incorrect storage (freezing, excessive heat)
    • use after the expiration date.
  • Too much carbohydrate intake. This can happen if you eat larger meals, eat more often, or increase the amount of carbohydrate in your meals.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that affect insulin. These medical conditions include fevers, infections, heart attacks, and stress.
  • Injecting insulin the wrong way or in the wrong injection area.

Testing your blood or urine often will let you know if you have hyperglycemia. If your tests are often high, tell your healthcare provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. Hyperglycemia can progress to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma) and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in patients with type 1 diabetes, it can also happen in patients with type 2 diabetes who become very sick. Because some patients get few symptoms of hyperglycemia, it is important to check your blood sugar/urine sugar and ketones regularly.

Symptoms of hyperglycemia include:

  • confusion or drowsiness
  • increased thirst
  • decreased appetite, nausea, or vomiting
  • rapid heart rate
  • increased urination and dehydration (too little fluid in your body).

Symptoms of DKA also include:

  • fruity smelling breath
  • fast, deep breathing
  • stomach area (abdominal) pain.

Severe or continuing hyperglycemia or DKA needs evaluation and treatment right away by your healthcare provider.

Do not use LANTUS to treat diabetic ketoacidosis.

Other possible side effects of LANTUS include:

Serious allergic reactions:

Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:

  • rash all over your body
  • shortness of breath
  • wheezing (trouble breathing)
  • fast pulse
  • sweating
  • low blood pressure.

Reactions at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

  • little depression in the skin (lipoatrophy)
  • skin thickening (lipohypertrophy)
  • red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site reaction if you change (rotate) the injection site each time. An injection site reaction should clear up in a few days or a few weeks. If injection site reactions do not go away or keep happening, call your healthcare provider.

Tell your healthcare provider if you have any side effects that bother you.

These are not all the side effects of LANTUS. Ask your healthcare provider or pharmacist for more information.

How should I store LANTUS?

  • Unopened vial:
    Store new (unopened) LANTUS vials in a refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze LANTUS. Keep LANTUS out of direct heat and light. If a vial has been frozen or overheated, throw it away.
  • Open (In-Use) vial:
    Once a vial is opened, you can keep it in a refrigerator or at room temperature (below 86°F [30°C]) but away from direct heat and light. Opened vial, either kept in a refrigerator or at room temperature, should be discarded 28 days after the first use even if it still contains LANTUS. Do not leave your insulin in a car on a summer day.

These storage conditions are summarized in the following table:

 

  Not in-use (unopened) Refrigerated Not in-use (unopened) Room Temperature In-use (opened) (See Temperature Below)
10 mL Vial Until expiration date 28 days 28 days Refrigerated or roomtemperature
  • Do not use a vial of LANTUS after the expiration date stamped on the label.
  • Do not use LANTUS if it is cloudy, colored, or if you see particles.

General Information about LANTUS

  • Use LANTUS only to treat your diabetes. Do not give or share LANTUS with another person, even if they have diabetes also. It may harm them.
  • This leaflet summarizes the most important information about LANTUS. If you would like more information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about LANTUS that is written for healthcare professionals. For more information about LANTUS call 1-800-633-1610 or go to website www.lantus.com.

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed especially for patients with diabetes and their families and is available by subscription from the American Diabetes Association (ADA), P.O.Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the ADA website at www.diabetes.org. Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International (JDRF), 120 Wall Street, 19th Floor, New York, New York 10005, 1800-JDF-CURE (1-800-533-2873). You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your healthcare professional or diabetes educator or visit www.DiabetesWatch.com.

Additional information about LANTUS can be obtained by calling 1-800-633-1610 or by visiting www.lantus.com.

LANTUS® SOLOSTAR®
(insulin glargine [rDNA origin] injection)

Instruction Leaflet

Your healthcare professional has decided that SoloStar® is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar® .

Read these instructions carefully before using your SoloStar®. If you are not able to follow all the instructions completely on your own, use SoloStar® only if you have help from a person who is able to follow the instructions.

Follow these instructions completely each time you use SoloStar® to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

SoloStar® is a disposable pen for the injection of insulin. Each SoloStar® contains in total 300 units of insulin. You can set doses from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose. The plunger will only move to the end of the cartridge when 300 units of insulin have been given.

Keep this leaflet for future reference.

If you have any questions about SoloStar® or about diabetes, ask your healthcare professional, go to www.lantus.com or call sanofi-aventis at 1-800-633-1610.

 

View Enlarged Table

Important information for use of SoloStar®:

  • Always attach a new needle before each use. BD Ultra-Fine needles are compatible with SoloStar®. These are sold separately and are manufactured by BD. Contact your healthcare professional for further information.
  • Always perform the safety test before each injection.
  • Do not select a dose or press the injection button without a needle attached.
  • This pen is only for your use. Do not share it with anyone else.
  • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
  • Never use SoloStar® if it is damaged or if you are not sure that it is working properly.
  • Always have a spare SoloStar® in case your SoloStar® is lost or damaged.

Storage Instructions

Please check the leaflet for the insulin for complete instructions on how to store SoloStar® .

If your SoloStar® is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep SoloStar® out of the reach and sight of children.

Keep your SoloStar® in cool storage (36°F - 46°F [2°C – 8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack.

Once you take your SoloStar® out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SoloStar® in use must not be stored in a refrigerator.

Do not use SoloStar® after the expiration date printed on the label of the pen or on the carton.

Protect SoloStar® from light.

Discard your used SoloStar® as required by your local authorities.

Maintenance

Protect your SoloStar® from dust and dirt.

You can clean the outside of your SoloStar® by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

Your SoloStar® is designed to work accurately and safely. It should be handled with care. Avoid

situations where SoloStar® might be damaged. If you are concerned that your SoloStar® may be damaged, use a new one.

Step 1. Check the insulin

A. Check the label on your SoloStar® to make sure you have the correct insulin. The Lantus® SoloStar® is grey with a purple injection button.

B. Take off the pen cap.

C. Check the appearance of your insulin. Lantus® is a clear insulin. Do not use this SoloStar® if the insulin is cloudy, colored or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.

A. Wipe the Rubber Seal with alcohol.

B. Remove the protective seal from a new needle.

C. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type)

 

Line up the needle with the pen - Illustration
  • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

 

Line up the needle with the pen - Illustration

Step 3. Perform a Safety test

Always perform the safety test before each injection.

Performing the safety test ensures that you get an accurate dose by:

  • ensuring that pen and needle work properly
  • removing air bubbles

A. Select a dose of 2 units by turning the dosage selector.

 

Select a dose of 2 units - Illustration

B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it

 

Take off the outer needle cap - Illustration

C. Hold the pen with the needle pointing upwards.

D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.

E. Press the injection button all the way in. Check if insulin comes out of the needle tip.

 

Check if insulin comes out of the needle tip - Illustration

You may have to perform the safety test several times before insulin is seen.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your SoloStar® may be damaged. Do not use this SoloStar® .

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

A. Check that the dose window shows “0” following the safety test.

B. Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

 

Select your required dose - Illustration
  • Do not push the injection button while turning, as insulin will come out.
  • You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar® or use a new SoloStar® for your full dose.

Step 5. Inject the dose

A. Use the injection method as instructed by your healthcare professional.

B. Insert the needle into the skin.

 

Inject the dose - Illustration

C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to “0” as you inject.

 

Deliver the dose by pressing the injection button in all the way - Illustration

D. Keep the injection button pressed all the way in.

Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

Step 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar® without a needle attached. This helps prevent:

  • Contamination and/or infection
  • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.

  • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B. Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly. If you are giving an injection to a third person, you should remove the needle in an approved manner to avoid needle-stick injuries.

C. Always put the pen cap back on the pen, then store the pen until your next injection.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

INSULIN GLARGINE - INJECTION

 

(IN-su-lin GLAR-jeen)

 

COMMON BRAND NAME(S): Lantus

 

USES: Insulin glargine is used along with a proper diet and exercise program to control high blood sugar. It is used in people with type 1 (insulin-dependent) or type 2 diabetes. Insulin glargine is a man-made, long-acting type of insulin that is similar to human insulin. It starts working more slowly and lasts for a longer time than regular insulin.

Insulin is a natural substance that allows the body to properly use sugar from the diet. It replaces the insulin that your body no longer produces, thereby lowering your blood sugar. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

 

HOW TO USE: Read the patient information leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Follow all package directions for proper use/injection/storage of the particular type of device/insulin you are using. Your health care professional will teach you how to properly inject this medication. If any of the information is unclear, consult your doctor or pharmacist.

Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature (see also Storage section). Wash your hands before measuring and injecting insulin. Before using, check the product visually for particles, thickening, or clumps. If any are present, discard that container. Insulin glargine should be clear and colorless. To avoid damaging the insulin, do not shake the container.

The dosage is based on your medical condition and response to treatment. Measure each dose carefully, and use exactly as prescribed by your doctor. Even small changes in the amount of insulin may have a large effect on your blood sugar levels. If you are using the cartridge form of this insulin and a special injecting device with a digital display, take care to read the display right-side up. If you read the display upside-down, you may inject the wrong amount of insulin. Ask your pharmacist if you are unsure how to properly use this type of injecting device.

Before injecting each dose, make sure the injection site is clean and dry. Inject this medication under the skin of the abdomen, upper arms, or thighs, usually once daily or as directed by your doctor. Do not rub the injection site. Do not inject into a vein or muscle. Change the location of the injection site daily and do not reuse the same site for two weeks to avoid problem areas under the skin.

Use this medication regularly as directed by your doctor in order to get the most benefit from it. You may inject insulin glargine once daily at any time during the day (such as before breakfast or at bedtime) but you should inject at the same time each day. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended.

Do not mix this product with other insulins or solutions, or use it in an insulin pump.

Monitor your blood sugar on a regular basis. Keep track of the results, and share them with your doctor. This is very important in order to determine the correct insulin dose. Inform your doctor if your blood sugar measurements are too high or too low. Your dosage may need to be changed.

If you are measuring doses from vials, do not reuse needles and syringes. If you are using the cartridges or pens, use a new needle each time. Learn how to discard needles and medical supplies safely. Consult your pharmacist for more information.

Consumer Overview Side Effect

SIDE EFFECTS: See also the How to Use section.

Pain, redness, swelling or itching at the injection site may occur. These effects usually go away after a few days or weeks. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Too much insulin can cause low blood sugar (hypoglycemia). This effect may also occur if you do not consume enough calories. The symptoms include chills, cold sweats, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose (sugar) tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent low blood sugar, eat meals on a regular schedule and do not skip meals.

Too little insulin can cause high blood sugar (hyperglycemia). Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your treatment plan may need to be changed.

This medication may cause low potassium levels in the blood (hypokalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Lantus (insulin glargine [rdna origin] injection) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor immediately if you experience symptoms of high or low blood sugar.

Do not use this medication when you have low blood sugar.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your treatment plan may be required.

Changes in your lifestyle or activity level may affect the amount of insulin your body needs to control blood sugar levels. If you notice an unusual change in your insulin needs, tell your doctor.

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across more than two time zones, ask your doctor about how to adjust your insulin schedule.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: rosiglitazone.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (such as cough-and-cold products) carefully. Some products may contain sugar or alcohol and may affect your blood sugar levels. Ask your doctor or pharmacist about using these products safely.

Other medications can affect the results of urine tests for sugar or ketones. Consult your doctor or pharmacist for more information.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, vision changes, unexplained heavy sweating, agitation, fainting, seizures.

 

NOTES: Do not share this medication, needles, or syringes with others.

Attend a diabetes education program to learn more about diabetes and the important aspects of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar.

Check your blood sugar levels regularly as directed. Keep all medical appointments. Laboratory and/or medical tests (such as fasting blood glucose, hemoglobin A1c) should be performed periodically to check for side effects and monitor your response to treatment.

Wear or carry identification stating that you have diabetes and are using this drug.

 

MISSED DOSE: It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Keep extra supplies of insulin and an extra syringe and needle on hand. Discuss specific instructions with your doctor now in case you miss a dose of insulin in the future.

 

STORAGE: See also the How to Use section.

Store all unopened insulin containers in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze, and do not use insulin that has been frozen. If you are using the vials, store open vials in the refrigerator or at room temperature below 86 degrees F (30 degrees C) away from direct heat and light. Store in the carton to protect from light. Do not refrigerate cartridges or pens that are currently in use. Discard all containers in use after 28 days, even if there is insulin left. Also discard all insulin products after the expiration date on the package. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Lantus, Lantus OptiClik Cartridge, Lantus Solostar Pen

Generic Name: insulin glargine (Pronunciation: IN su lin AS part, IN su lin AS part PRO ta meen)

  • What is insulin glargine (Lantus)?
  • What are the possible side effects of insulin glargine (Lantus)?
  • What is the most important information I should know about insulin glargine (Lantus)?
  • What should I discuss with my healthcare provider before using insulin glargine (Lantus)?
  • How should I use insulin glargine (Lantus)?
  • What happens if I miss a dose (Lantus)?
  • What happens if I overdose (Lantus)?
  • What should I avoid while using insulin glargine (Lantus)?
  • What other drugs will affect insulin glargine (Lantus)?
  • Where can I get more information?

What is insulin glargine (Lantus)?

Insulin glargine is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin glargine is used to treat type 1 or type 2 diabetes.

Insulin glargine may also be used for purposes not listed in this medication guide.

What are the possible side effects of insulin glargine (Lantus)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glargine. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glargine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Lantus (insulin glargine [rdna origin] injection) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about insulin glargine (Lantus)?

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin glargine dose.

Insulin glargine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Side Effects Centers
  • Lantus

Patient Detailed How Take

What should I discuss with my healthcare provider before using insulin glargine (Lantus)?

Do not use this medication if you are allergic to insulin glargine.

To make sure you can safely take insulin glargine, tell your doctor if you have liver or kidney disease.

FDA pregnancy category C. It is not known whether insulin glargine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether insulin glargine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use insulin glargine (Lantus)?

Insulin glargine is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. You should not mix this medication with other insulins.

Insulin glargine should be thin, clear, and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use a different place in your injection skin area each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

The SoloStar injection pen contains a total of 300 units of insulin. The pen is designed to deliver from 1 to 80 units with each press of the injection button. Do not press the button more than one time per injection unless your doctor has prescribed a dose greater than 80 units.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Your dose needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Your doctor may want you to stop taking insulin glargine for a short time if any of these situations affect you. Ask your doctor how to adjust your insulin glargine dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Insulin glargine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Wear a medical alert tag or carry an ID card stating that you use insulin. Any medical care provider who treats you should know that you are diabetic.

Storing unopened vials, OptiClik, or SoloStar devices: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Store the injection pen with its cap on.

Unopened vials, OptiClik, or SoloStar devices may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days.

Storing after your first use: You may keep "in-use" vials or cartridges not yet loaded into the OptiClik in the refrigerator or at room temperature, protected from light. Use within 28 days.

Do not refrigerate an in-use OptiClik or SoloStar device, or a cartridge that has been inserted into the OptiClik. Keep it at room temperature and use within 28 days.

Do not freeze insulin glargine, and throw away the medication if it has become frozen.

Side Effects Centers
  • Lantus

Patient Detailed Avoid Taking

What happens if I miss a dose (Lantus)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. You should not use more than one dose in a 24-hour period unless your doctor tells you to.

Keep insulin glargine on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose (Lantus)?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

What should I avoid while using insulin glargine (Lantus)?

Do not change the brand of insulin glargine or syringe you are using without first talking to your doctor or pharmacist.

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What other drugs will affect insulin glargine (Lantus)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

  • albuterol (Proventil, Ventolin);
  • clonidine (Catapres);
  • reserpine; or
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

There are many other medicines that can increase or decrease the effects of insulin glargine on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about insulin glargine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.02. Revision date: 11/23/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers
  • Lantus

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