Drugs Details

Drugs Info of Humalog, Humalog Cartridge, Humalog KwikPen, Humalog Pen
Drugs Details
  • Drugs Type  : Multum
  • Date : 2nd Feb 2015 03:39 am
  • Brand Name : Humalog, Humalog Cartridge, Humalog KwikPen, Humalog Pen
  • Generic Name :  insulin lispro (Pronunciation: IN soo lin LISS pro)
Descriptions

HUMALOG® (insulin lispro injection, USP [rDNA origin]) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin.

HUMALOG has the following primary structure:

 

View Enlarged Table

HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%.

What are the possible side effects of insulin lispro (Humalog, Humalog Cartridge, Humalog KwikPen, Humalog 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 lispro. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for...

Read All Potential Side Effects and See Pictures of Humalog »

What are the precautions when taking insulin lispro (human analog) (Humalog)?

Before using insulin lispro, tell your doctor or pharmacist if you are allergic to it; or to other insulins; 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.

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

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

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...

Read All Potential Precautions of Humalog »


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

Indications

HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Dosage Administration

Dosage Considerations

When given subcutaneously, HUMALOG has a more rapid onset of action and a shorter duration of action than regular human insulin.

The dosage of HUMALOG must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.

The total daily insulin requirement may vary and is usually between 0.5 to 1 unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Subcutaneous Administration

HUMALOG should be given within 15 minutes before a meal or immediately after a meal.

HUMALOG given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.

HUMALOG administered by subcutaneous injection should be given in the abdominal wall, thigh, upper arm, or buttocks. Injection sites should be rotated within the same region (abdomen, thigh, upper arm, or buttocks) from one injection to the next to reduce the risk of lipodystrophy [see ADVERSE REACTIONS].

Continuous Subcutaneous Infusion (Insulin Pump)

HUMALOG may be administered by continuous subcutaneous infusion by an external insulin pump. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy [see ADVERSE REACTIONS]. Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days.

The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant variability among patients, approximately 50% of the total dose is usually given as meal-related boluses of HUMALOG and the remainder is given as a basal infusion. HUMALOG is recommended for use in pump systems suitable for insulin infusion such as MiniMed, Disetronic, and other equivalent pumps [see For Patients Using Continuous Subcutaneous Insulin Pumps].

Intravenous Administration

HUMALOG can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see WARNINGS AND PRECAUTIONS, HOW SUPPLIED/Storage and Handling]. HUMALOG should be used at concentrations from 0.1 unit/mL to 1.0 unit/mL in infusion systems containing 0.9% sodium chloride.

How Supplied

Dosage Forms And Strengths

HUMALOG 100 units per mL (U-100) is available as:

  • 10 mL vials
  • 3 mL prefilled pens
  • 3 mL Humalog KwikPen (prefilled)
  • 3 mL cartridges

HUMALOG 100 units per mL (U-100) is available as:

 

10 mL vials NDC 0002-7510-01 (VL-7510)
5 x 3 mL cartridges1 NDC 0002-7516-59 (VL-7516)
5 x 3 mL prefilled pen NDC 0002-8725-59 (HP-8725)
5 x 3 mL Humalog KwikPen (prefilled) NDC 0002-8799-59 (HP-8799)

Storage and Handling

Do not use after the expiration date.

Unopened HUMALOG should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use HUMALOG if it has been frozen. In-use HUMALOG vials, cartridges, pens, and HUMALOG KwikPen should be stored at room temperature, below 86°F (30°C) and must be used within 28 days or be discarded, even if they still contain HUMALOG. Protect from direct heat and light. See table below:

 

  Not In-Use (Unopened) Room Temperature (Below 86°F [30°C]) Not In-Use (Unopened) Refrigerated In-Use (Opened) Room Temperature, (Below 86°F [30°C])
10 mL vial 28 days Until expiration date 28 days, refrigerated/room temperature.
3 mL cartridge 28 days Until expiration date 28 days, Do not refrigerate.
3 mL prefilled pen 28 days Until expiration date 28 days, Do not refrigerate.
3 mL Humalog KwikPen (prefilled) 28 days Until expiration date 28 days, Do not refrigerate.

Use in an External Insulin Pump Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days or after exposure to temperatures that exceed 98.6°F (37°C). A HUMALOG 3 mL cartridge used in the D-Tron pumps should be discarded after 7 days, even if it still contains HUMALOG. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days.

Diluted HUMALOG for Subcutaneous Injection Diluted HUMALOG may remain in patient use for 28 days when stored at 41°F (5°C) and for 14 days when stored at 86°F (30°C). Do not dilute HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump.

Preparation and Handling

Diluted HUMALOG for Subcutaneous Injection HUMALOG may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection. Diluting one part HUMALOG to nine parts diluent will yield a concentration one-tenth that of HUMALOG (equivalent to U-10). Diluting one part HUMALOG to one part diluent will yield a concentration one-half that of HUMALOG (equivalent to U-50).

Admixture for Intravenous Administration

Infusion bags prepared with HUMALOG are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours [see DOSAGE AND ADMINISTRATION].

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Revised: 03/2013


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].
  • Hypokalemia [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 with 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 HUMALOG 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 Patients with Type 1 Diabetes Mellitus (adverse events with frequency ≥ 5%)

Events, n (%) Lispro
(n=81)
Regular human insulin
(n=86)
Total
(n=167)
Flu syndrome 28 (34.6) 28 (32.6) 56 (33.5)
Pharyngitis 27 (33.3) 29 (33.7) 56 (33.5)
Rhinitis 20 (24.7) 25 (29.1) 45 (26.9)
Headache 24 (29.6) 19 (22.1) 43 (25.7)
Pain 16 (19.8) 14 (16.3) 30 (18.0)
Cough increased 14 (17.3) 15 (17.4) 29 (17.4)
Infection 11 (13.6) 18 (20.9) 29 (17.4)
Nausea 5 (6.2) 13 (15.1) 18 (10.8)
Accidental injury 7 (8.6) 10 (11.6) 17 (10.2)
Surgical procedure 5 (6.2) 12 (14.0) 17 (10.2)
Fever 5 (6.2) 10 (11.6) 15 (9.0)
Abdominal pain 6 (7.4) 7 (8.1) 13 (7.8)
Asthenia 6 (7.4) 7 (8.1) 13 (7.8)
Bronchitis 6 (7.4) 6 (7.0) 12 (7.2)
Diarrhea 7 (8.6) 5 (5.8) 12 (7.2)
Dysmenorrhea 5 (6.2) 6 (7.0) 11 (6.6)
Myalgia 6 (7.4) 5 (5.8) 11 (6.6)
Urinary tract infection 5 (6.2) 4 (4.7) 9 (5.4)

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (adverse events with frequency ≥ 5%)

Events, n (%) Lispro
(n=714)
Regular human insulin
(n=709)
Total
(n=1423)
Headache 63 (11.6) 66 (9.3) 149 (10.5)
Pain 77 (10.8) 71 (10.0) 148 (10.4)
Infection 72 (10.1) 54 (7.6) 126 (8.9)
Pharyngitis 47 (6.6) 58 (8.2) 105 (7.4)
Rhinitis 58 (8.1) 47 (6.6) 105 (7.4)
Flu syndrome 44 (6.2) 58 (8.2) 102 (7.2)
Surgical procedure 53 (7.4) 48 (6.8) 101 (7.1)
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 HUMALOG, can cause lipodystrophy at the site of repeated insulin injections or infusion. 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 HUMALOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Peripheral Edema

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

Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)

In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for HUMALOG and regular human insulin treated patients (see Table 3).

Table 3: Catheter Occlusions and Infusion Site Reactions

  HUMALOG
(n=38)
Regular human insulin
(n=39)
Catheter occlusions/month 0.09 0.1
Infusion site reactions 2.6% (1/38) 2.6% (1/39)

In a randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes, adverse event reports related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion site adverse events were infusion site erythema and infusion site reaction.

Allergic Reactions

Local Allergy As with any insulin therapy, patients taking HUMALOG may experience redness, swelling, or itching at the site of the injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of HUMALOG. 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.

Systemic Allergy Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including HUMALOG. Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.

In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n=2969) and 30 patients receiving HUMALOG (n=2944).

Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in HUMALOG [see CONTRAINDICATIONS].

Antibody Production

In large clinical trials with patients with type 1 (n=509) and type 2 (n=262) diabetes mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and HUMALOG (including patients previously treated with human insulin and naive patients). As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy. The antibody levels peaked by 12 months and declined over the remaining years of the study. These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose. There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types.

Postmarketing Experience

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

Medication errors in which other insulins have been accidentally substituted for HUMALOG have been identified during postapproval use [see PATIENT INFORMATION].

Read the Humalog (insulin lispro (human analog)) Side Effects Center for a complete guide to possible side effects

Interactions

A number of drugs affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring. Following are some of the examples:

  • Drugs That May Increase the Blood-Glucose-Lowering Effect of HUMALOG and Susceptibility to Hypoglycemia: Oral antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide).
  • Drugs That May Reduce the Blood-Glucose-Lowering Effect of HUMALOG: corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones.
  • Drugs That May Increase or Reduce the Blood-Glucose-Lowering Effect of HUMALOG: beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
  • Drugs That May Reduce the Signs of Hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.

Read the Humalog 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

Dose Adjustment and Monitoring

Glucose monitoring is essential for 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. Concomitant oral antidiabetic treatment may need to be adjusted.

As with all insulin preparations, the time course of action for HUMALOG may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages.

Hypoglycemia

Hypoglycemia is the most common adverse effect associated with insulins, including HUMALOG. The risk of hypoglycemia increases with tighter glycemic control. Patients must be educated to recognize and manage hypoglycemia. Hypoglycemia can happen suddenly and symptoms may be different for each person and may change from time to time. Severe hypoglycemia can cause seizures and may be life-threatening or cause death.

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), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia [see DRUG INTERACTIONS].

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.

Rapid changes in serum glucose levels may induce symptoms similar to hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic nerve disease, use of medications such as beta-blockers [see DRUG INTERACTIONS], or intensified diabetes 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 HUMALOG [see ADVERSE REACTIONS].

Hypokalemia

All insulin products, including HUMALOG, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations and patients receiving intravenously administered insulin).

Renal or Hepatic Impairment

Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment [see CLINICAL PHARMACOLOGY].

Mixing of Insulins

HUMALOG for subcutaneous injection should not be mixed with insulin preparations other than NPH insulin. If HUMALOG is mixed with NPH insulin, HUMALOG should be drawn into the syringe first. Injection should occur immediately after mixing. Do not mix HUMALOG with other insulins for use in an external subcutaneous infusion pump.

Subcutaneous Insulin Infusion Pumps

When used in an external insulin pump for subcutaneous infusion, HUMALOG should not be diluted or mixed with any other insulin. Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days. HUMALOG should not be exposed to temperatures greater than 98.6°F (37°C).

Malfunction of the insulin pump or infusion set or insulin degradation can rapidly lead to hyperglycemia and ketosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with HUMALOG may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure [see DOSAGE AND ADMINISTRATION, HOW SUPPLIED/Storage and Handling, and PATIENT INFORMATION].

Drug Interactions

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

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including HUMALOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Instructions for All Patients

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. Refer patients to the HUMALOG Patient Information Leaflet for additional information.

Women with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.

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

For Patients Using Continuous Subcutaneous Insulin Pumps

Patients using external pump infusion therapy should be trained appropriately.

The following insulin pumps have been tested in HUMALOG clinical trials conducted by Eli Lilly and Company.

  • Disetronic® H-Tron® plus V100, D-Tron® and D-Tronplus® with Disetronic Rapid infusion sets
  • MiniMed® Models 506, 507 and 508 and Polyfin® infusion sets3

HUMALOG is recommended for use in pump systems suitable for insulin infusion such as MiniMed, Disetronic, and other equivalent pumps. Before using HUMALOG in a pump system, read the pump label to make sure the pump is indicated for continuous delivery of fast-acting insulin. HUMALOG is recommended for use in any reservoir and infusion sets that are compatible with insulin and the specific pump. Please see recommended reservoir and infusion sets in the pump manual.

To avoid insulin degradation, infusion set occlusion, and loss of the preservative (metacresol), insulin in the reservoir should be replaced at least every 7 days; infusion sets and infusion set insertion sites should be changed at least every 3 days.

Insulin exposed to temperatures higher than 98.6°F (37°C) should be discarded. The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing or sport case is exposed to sunlight or radiant heat. Infusion sites that are erythematous, pruritic, or thickened should be reported to the healthcare professional, and a new site selected because continued infusion may increase the skin reaction or alter the absorption of HUMALOG.

Pump or infusion set malfunctions or insulin degradation can lead to rapid hyperglycemia and ketosis. This is especially pertinent for rapid acting insulin analogs that are more rapidly absorbed through skin and have a shorter duration of action. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Problems include pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Less commonly, hypoglycemia from pump malfunction may occur. If these problems cannot be promptly corrected, patients should resume therapy with subcutaneous insulin injection and contact their healthcare professionals. [See DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and HOW SUPPLIED/Storage and Handling].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard 2-year carcinogenicity studies in animals have not been performed. In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose.

Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration and micronucleus assays.

Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.16, 0.8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

Use In Specific Populations

Pregnancy

Pregnancy Category B

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes 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. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking HUMALOG.

Although there are limited clinical studies of the use of HUMALOG in pregnancy, published studies with human insulins suggest that optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome.

In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19. There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter.

In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.24 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation days 7 through 19. There were no adverse effects on fetal viability, weight, and morphology at any dose.

Nursing Mothers

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

Pediatric Use

HUMALOG is approved for use in children for subcutaneous daily injections and for subcutaneous continuous infusion by external insulin pump. HUMALOG has not been studied in pediatric patients younger than 3 years of age. HUMALOG has not been studied in pediatric patients with type 2 diabetes [see Clinical Studies].

As in adults, the dosage of HUMALOG must be individualized in pediatric patients based on metabolic needs and results of frequent monitoring of blood glucose.

Geriatric Use

Of the total number of subjects (n=2834) in eight clinical studies of HUMALOG, twelve percent (n=338) were 65 years of age or over. The majority of these had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of HUMALOG action have not been performed.


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

OverDose

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

ContrainDications

HUMALOG is contraindicated:

  • during episodes of hypoglycemia
  • in patients who are hypersensitive to HUMALOG or to any of its excipients.


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

Clinical Pharamacology

The following adverse reactions are discussed elsewhere:

  • Hypoglycemia [see WARNINGS AND PRECAUTIONS].
  • Hypokalemia [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 with 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 HUMALOG 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 Patients with Type 1 Diabetes Mellitus (adverse events with frequency ≥ 5%)

Events, n (%) Lispro
(n=81)
Regular human insulin
(n=86)
Total
(n=167)
Flu syndrome 28 (34.6) 28 (32.6) 56 (33.5)
Pharyngitis 27 (33.3) 29 (33.7) 56 (33.5)
Rhinitis 20 (24.7) 25 (29.1) 45 (26.9)
Headache 24 (29.6) 19 (22.1) 43 (25.7)
Pain 16 (19.8) 14 (16.3) 30 (18.0)
Cough increased 14 (17.3) 15 (17.4) 29 (17.4)
Infection 11 (13.6) 18 (20.9) 29 (17.4)
Nausea 5 (6.2) 13 (15.1) 18 (10.8)
Accidental injury 7 (8.6) 10 (11.6) 17 (10.2)
Surgical procedure 5 (6.2) 12 (14.0) 17 (10.2)
Fever 5 (6.2) 10 (11.6) 15 (9.0)
Abdominal pain 6 (7.4) 7 (8.1) 13 (7.8)
Asthenia 6 (7.4) 7 (8.1) 13 (7.8)
Bronchitis 6 (7.4) 6 (7.0) 12 (7.2)
Diarrhea 7 (8.6) 5 (5.8) 12 (7.2)
Dysmenorrhea 5 (6.2) 6 (7.0) 11 (6.6)
Myalgia 6 (7.4) 5 (5.8) 11 (6.6)
Urinary tract infection 5 (6.2) 4 (4.7) 9 (5.4)

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (adverse events with frequency ≥ 5%)

Events, n (%) Lispro
(n=714)
Regular human insulin
(n=709)
Total
(n=1423)
Headache 63 (11.6) 66 (9.3) 149 (10.5)
Pain 77 (10.8) 71 (10.0) 148 (10.4)
Infection 72 (10.1) 54 (7.6) 126 (8.9)
Pharyngitis 47 (6.6) 58 (8.2) 105 (7.4)
Rhinitis 58 (8.1) 47 (6.6) 105 (7.4)
Flu syndrome 44 (6.2) 58 (8.2) 102 (7.2)
Surgical procedure 53 (7.4) 48 (6.8) 101 (7.1)
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 HUMALOG, can cause lipodystrophy at the site of repeated insulin injections or infusion. 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 HUMALOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Peripheral Edema

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

Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)

In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for HUMALOG and regular human insulin treated patients (see Table 3).

Table 3: Catheter Occlusions and Infusion Site Reactions

  HUMALOG
(n=38)
Regular human insulin
(n=39)
Catheter occlusions/month 0.09 0.1
Infusion site reactions 2.6% (1/38) 2.6% (1/39)

In a randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes, adverse event reports related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion site adverse events were infusion site erythema and infusion site reaction.

Allergic Reactions

Local Allergy As with any insulin therapy, patients taking HUMALOG may experience redness, swelling, or itching at the site of the injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of HUMALOG. 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.

Systemic Allergy Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including HUMALOG. Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.

In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n=2969) and 30 patients receiving HUMALOG (n=2944).

Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in HUMALOG [see CONTRAINDICATIONS].

Antibody Production

In large clinical trials with patients with type 1 (n=509) and type 2 (n=262) diabetes mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and HUMALOG (including patients previously treated with human insulin and naive patients). As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy. The antibody levels peaked by 12 months and declined over the remaining years of the study. These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose. There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types.

Postmarketing Experience

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

Medication errors in which other insulins have been accidentally substituted for HUMALOG have been identified during postapproval use [see PATIENT INFORMATION].

Read the Humalog (insulin lispro (human analog)) Side Effects Center for a complete guide to possible side effects

Learn More »

DRUG INTERACTIONS

A number of drugs affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring. Following are some of the examples:

  • Drugs That May Increase the Blood-Glucose-Lowering Effect of HUMALOG and Susceptibility to Hypoglycemia: Oral antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide).
  • Drugs That May Reduce the Blood-Glucose-Lowering Effect of HUMALOG: corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones.
  • Drugs That May Increase or Reduce the Blood-Glucose-Lowering Effect of HUMALOG: beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
  • Drugs That May Reduce the Signs of Hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.


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

Patient Information

HUMALOG® insulin lispro injection, USP
(rDNA origin)

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

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

  • Do not change the insulin you use without talking to your healthcare provider. Anychange in insulin strength, manufacturer, type (regular, NPH, analog) may need a change in the dose you are using. This dose change may be needed right away or later on. Sometimes this dose change may happen 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 HUMALOG. 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.
  • When used in a pump do not mix HUMALOG with any other insulin or liquid.

What is HUMALOG?

HUMALOG (insulin lispro injection, USP [rDNA origin]) is an injectable rapid-acting man-made insulin. HUMALOG is used to treat people with diabetes for the control of high blood sugar.

  • HUMALOG is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
  • You need a prescription to get HUMALOG. Always be sure you receive the right insulin from the pharmacy.

HUMALOG comes in:

  • 10 mL vials (bottles) for use with a syringe or external insulin pump
  • 3 mL prefilled pens
  • 3 mL Humalog® KwikPen™
  • 3 mL cartridges for use with a reusable pen or external insulin pump

Who should not take HUMALOG?

Do not take HUMALOG if:

  • your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of HUMALOG.
  • you are allergic to insulin lispro or any of the ingredients in HUMALOG. See the end of this leaflet for a complete list of ingredients in HUMALOG. Check with your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking HUMALOG?

Before you use HUMALOG, tell your healthcare provider if you:

  • have liver or kidney problems or any other medical conditions. Your dose may need to be adjusted.
  • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with HUMALOG.
  • are pregnant or breastfeeding. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant or breastfeeding. HUMALOG has not been studied in pregnant or nursing women.
  • take other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements. Your HUMALOG dose may need to change if you take other medicines.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I use HUMALOG?

HUMALOG can be used with a syringe, prefilled pen, reusable pen or external insulin pump. Talk to your healthcare provider if you have any questions.

  • Read the instructions for use that comes with your HUMALOG product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject HUMALOG before you start taking it.
  • HUMALOG is a rapid-acting insulin. You should take HUMALOG within fifteen minutes before eating or right after eating a meal.
  • Only use HUMALOG that is clear and colorless. If your HUMALOG is cloudy, colored, or has solid particles or clumps in it, return it to your pharmacy for a replacement.
  • Do not mix HUMALOG:
    • with any type of insulin other than NPH when used with injections by syringe.
    • with any other insulin or liquid when used in a pump.
  • If your doctor recommends diluting HUMALOG, follow your doctor's instructions exactly so that you know:
    • How to make HUMALOG more dilute (that is, a smaller number of units of HUMALOG for a given amount of liquid) and
    • How to use this more dilute form of HUMALOG. Do not use dilute insulin in a pump.
  • Inject HUMALOG under your skin (subcutaneously) in your upper arm, abdomen (stomach area), thigh (upper leg), or buttocks. Never inject it into a vein or muscle.
  • Change (rotate) your injection site with each dose.
  • If you have type 1 diabetes, you need to take a longer-acting insulin in addition to HUMALOG (except when using an external insulin pump).
  • If you have type 2 diabetes, you may be taking oral anti-diabetic medicines and/or a longer-acting insulin in addition to HUMALOG.
  • 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. Always make sure that you received the correct type of HUMALOG from the pharmacy. Check to make sure you are injecting the correct insulin and dose, especially if you use other insulin with HUMALOG.
  • If you take too much HUMALOG, your blood sugar may fall low (hypoglycemia).You can treat mild low blood sugar by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar right away because it could get worse and you could pass out (become unconscious). If you pass out, you will need help from another person or emergency medical services right away, and will need treatment with glucagon injection or treatment at a hospital. See “What are the possible side effects of HUMALOG?” for more information on low blood sugar.
  • If you forget to take your dose of HUMALOG, your blood sugar may go too high (hyperglycemia). If high blood sugar is not treated it can lead to serious problems like loss of consciousness (passing out), coma or even death. Follow your healthcare provider's instructions for treating high blood sugar. Know your symptoms of high blood sugar which may include:
    • increased thirst
    • frequent urination
    • drowsiness
    • loss of appetite
    • a hard time breathing
    • fruity smell on the breath
    • high amounts of sugar and ketones in your urine
    • nausea, vomiting (throwing up) or stomach pain
  • Your insulin dosage may need to change because of:
    • illness
    • stress
    • other medicines you take
    • change in diet
    • change in physical activity or exercise

What are the possible side effects of HUMALOG?

  • low blood sugar (hypoglycemia). Symptoms of low blood sugar may include:
    • sweating
    • dizziness or lightheadedness
    • shakiness
    • hunger
    • fast heart beat
    • tingling of lips and tongue
    • trouble concentrating or confusion
    • blurred vision
    • slurred speech
    • anxiety, irritability or mood changes
    • headache
  • Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar may affect your ability to drive a car or use mechanical equipment, risking injury to yourself or others. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.
  • Serious allergic reaction (whole body reaction). Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
  • Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your healthcare provider. You may need to stop using HUMALOG and use a different insulin. Do not inject insulin to skin that is red, swollen or itchy.
  • Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) when youinject your insulin to help to prevent these skin changes from happening. Do not inject insulin into this type of skin.
  • Low potassium in your blood (hypokalemia)
  • Weight gain

HUMALOG may cause serious side effects, including:

  • swelling of your hands and feet
  • heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with HUMALOG may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with HUMALOG. Your healthcare provider should monitor you closely while you are taking TZDs with HUMALOG. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain

Treatment with TZDs and HUMALOG may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store HUMALOG?

  • Store all unopened (unused) HUMALOG in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze. Do not use HUMALOG if it has been frozen.
  • Keep unopened HUMALOG in the carton to protect from light.

After starting use (open)

Vials:

  • Keep in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days.
  • Keep vials away from direct heat or light.
  • Throw away an opened vial after 28 days of use, even if there is insulin left in the vial.
  • Unopened vials can be used until the expiration date on the HUMALOG carton and label, if the medicine has been stored in a refrigerator.

Cartridge and Prefilled Pens:

  • Keep at room temperature below 86°F (30°C) for up to 28 days.
  • Do not store a cartridge or prefilled pen that you are using in the refrigerator.
  • Keep cartridges and prefilled pens away from direct heat or light.
  • A cartridge used in the D-Tron1 or D-Tronplus1 pump may be used for up to 7 days.
  • Throw away a used cartridge or prefilled pen after 28 days, even if there is insulin left in the cartridge or the pen.

General Information about HUMALOG

  • HUMALOG in the pump reservoir and the complete external pump infusion set:
    • When HUMALOG is used in pumps, use only pumps that are recommended byyour healthcare provider.
    • The infusion set and infusion site should be changed at least every 3 days.
    • The insulin in the reservoir should be changed at least every 7 days even if you havenot used all of the insulin.
    • Change the infusion set and infusion site more often than every 3 days if you have high blood sugar (hyperglycemia), the pump alarms sounds, or the insulin flow is blocked (occlusion).
  • Do not use HUMALOG for a condition for which it was not prescribed. Do not give orshare HUMALOG with another person, even if they also have diabetes. It may harmthem.
  • This leaflet summarizes the most important information about HUMALOG. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about HUMALOG that is written for healthcare providers. For more information about HUMALOG, call 1-800-LillyRx (1-800-545-5979) or visit www.humalog.com.

What are the ingredients in HUMALOG?

insulin lispro, glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), trace amounts of phenol and water for injection.

Helpful information for people with diabetes is published by the American Diabetes Association,1660 Duke Street, Alexandria, VA 22314 and on www.diabetes.org.

Instructions for Use

HUMALOG® KwikPen™ insulin lispro injection
(rDNA origin)

 

View Enlarged Table

Read the Instructions for Use before you start taking HUMALOG and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

HUMALOG® KwikPen™ (“Pen”) is a disposable pen containing 3 mL (300 units) of U100 HUMALOG® [insulin lispro injection (rDNA origin)] insulin. You can inject from 1 to 60 units in a single injection.

Do not share your HUMALOG KwikPen or needles with anyone else. You may give an infection to them or get an infection from them.

This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

 

View Enlarged Table

Supplies you will need to give your HUMALOG injection:

  • HUMALOG KwikPen
  • HUMALOG KwikPen compatible needle (Becton, Dickinson and Company Pen Needles recommended)
  • Alcohol swab

Preparing HUMALOG KwikPen:

  • Wash your hands with soap and water.
  • Check the HUMALOG KwikPen Label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
  • Do not use HUMALOG past the expiration date printed on the Label.
  • Always use a new needle for each injection to help ensure sterility and prevent blocked needles.

Step 1:

Pull the Pen Cap straight off. Wipe the Rubber Seal with an alcohol swab.

  • Do not twist the cap.
  • Do not remove the KwikPen Label.

HUMALOG should look clear and colorless. Do not use HUMALOG if it is thick, cloudy, colored, has solid particles or clumps in it.

 

Pull the Pen Cap straight off - Illustration

Step 2:

Pull off the Paper Tab from Outer Needle Shield.

 

Pull off the Paper Tab - Illustration

Step 3:

Push the capped Needle straight onto the Pen and turn the Needle forward until it is tight.

 

Turn the Needle forward - Illustration

Step 4:

Pull off the Outer Needle Shield. Do not throw it away.

Pull off the Inner Needle Shield and throw it away.

 

Pull off the Inner Needle Shield - Illustration

Priming your HUMALOG KwikPen:

Prime before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.

Step 5:

Turn the Dose Knob to select 2 units.

 

Turn the Dose Knob to select 2 units - Illustration

Step 6:

Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

 

Tap the Cartridge Holder - Illustration

Step 7: Hold your Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window. Hold the Dose Knob in and count to 5 slowly.

  • A stream of insulin should be seen from the needle.
    • If you do not see a stream of insulin, repeat steps 5 to 7, no more than 4 times.
    • If you still do not see a stream of insulin, change the needle and repeat steps 5 to 7.

 

Hold the Dose Knob in and count to 5 - Illustration

Selecting your dose:

Step 8:

Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.

  • The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.
  • The even numbers are printed on the dial. The odd numbers, after the number 1, are shown as full lines.

 

Selecting your dose - Illustration
  • The HUMALOG KwikPen will not let you dial more than the number of units left in the Pen.
  • If your dose is more than the number of units left in the Pen, you may either:
    • inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or
    • get a new Pen and inject the full dose.
  • The Pen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that can't be delivered.

Giving your HUMALOG injection:

  • Inject your HUMALOG as your healthcare provider has shown you.
  • Change (rotate) your injection site for each injection.
  • Do not try to change your dose while injecting HUMALOG.

Step 9:

Choose your injection site.

HUMALOG is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.

Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.

 

Choose your injection site - Illustration

Step 10:

Insert the Needle into your skin.

 

Insert the Needle into your skin - Illustration

Step 11:

Put your thumb on the Dose Knob and push the Dose Knob in until it stops. Hold the Dose Knob in and slowly count to 5.

 

Hold the Dose Knob in and slowly count to 5 - Illustration

Step 12:

Pull the Needle out of your skin.

You should see “0” in the Dose Window. If you do not see “0” in the Dose Window, you did not receive your full dose.

If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.

A drop of insulin at the needle tip is normal. It will not affect your dose.

If you do not think you received your full dose, do not take another dose. Call Lilly or your healthcare provider for assistance.

 

You should see “0” in the Dose Window - Illustration

Step 13:

Carefully replace the Outer Needle Shield.

 

Carefully replace the Outer Needle Shield - Illustration

Step 14:

Unscrew the capped Needle and throw it away.

Do not store the Pen with the Needle attached to prevent leaking, blocking of the Needle, and air from entering the Pen.

 

Unscrew the capped Needle - Illustration

Step 15:

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

 

Replace the Pen Cap -  Illustration

After your injection:

  • Put your used needles and pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

How should I store my HUMALOG KwikPen?

  • Store unused HUMALOG Pens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using can be stored out of the refrigerator below 86°F (30°C).
  • Do not freeze HUMALOG. Do not use HUMALOG if it has been frozen.
  • Unused HUMALOG Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
  • The HUMALOG Pen you are using should be thrown away after 28 days, even if it still has insulin left in it.
  • Keep HUMALOG away from heat and out of the light.

General information about the safe and effective use of HUMALOG KwikPen

  • Keep HUMALOG KwikPen and needles out of the reach of children.
  • Do not use your Pen if any part looks broken or damaged.
  • Always carry an extra Pen in case yours is lost or damaged.
  • If you can not remove the Pen Cap, gently twist the Pen Cap back and forth, and then pull the Pen Cap straight off.
  • If it is hard to push the Dose Knob or the Pen is not working the right way:
    • Your Needle may be blocked. Put on a new Needle and prime the Pen.
    • You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new one.
    • It may help to push the Dose Knob more slowly during your injection.
  • Use the space below to keep track of how long you should use each HUMALOG KwikPen.
    • Write down the date you start using your HUMALOG KwikPen. Count forward 28 days.
    • Write down the date you should throw it away.

Example:

Pen 1 - First used on [Date] _______ + 28 days = Throw out on [Date]______

Pen 1 - First used on [Date] _______ Throw out on [Date]_______

Pen 2 - First used on [Date] _______ Throw out on [Date]_______

Pen 3 - First used on [Date]_______ Throw out on [Date]_______

Pen 4 - First used on [Date]_______ Throw out on [Date]_______

Pen 5 - First used on [Date]_______ Throw out on [Date]_______

If you have any questions or problems with your HUMALOG KwikPen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMALOG KwikPen and insulin, go to www.humalog.com.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.


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 LISPRO - INJECTION

 

(IN-su-lin LIS-proe)

 

COMMON BRAND NAME(S): Humalog

 

USES: Insulin lispro is used with a proper diet and exercise program to control high blood sugar in people with diabetes. 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.

Insulin lispro is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. Insulin lispro starts working faster and lasts for a shorter time than regular insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication is usually used with a medium- or long-acting insulin product. Insulin lispro may also be used with other oral diabetes medications (such as sulfonylureas like glyburide or glipizide).

 

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, ask your doctor, diabetes educator, or pharmacist.

Learn all preparation and usage instructions from your health care professional and the product package.

Before using, check this product visually for particles or discoloration. If either is present, do not use the insulin. Insulin lispro should be clear and colorless.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin and to avoid developing problems under the skin (lipodystrophy). Insulin lispro may be injected in the stomach area, the thigh, the buttocks, or the back of the upper arm. Do not inject into skin that is red, swollen, or itchy. 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).

Inject this medication under the skin as directed by your doctor, usually within 15 minutes before eating a meal or immediately after a meal. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. Because this insulin is fast-acting, not eating right after a dose of insulin may also lead to low blood sugar. Do not inject if you have low blood sugar. Do not rub the area after the injection.

Giving insulin lispro into a vein should only be done by a health care professional. Very low blood sugar may result.

If you are directed to inject this insulin with an infusion pump, read the instruction manual and directions that come with the infusion pump. If you have any questions, ask your health care professional. Avoid exposing the pump or its tubing to direct sunlight or other heat sources. Do not dilute insulin if you are using an insulin pump.

This product may be mixed only with certain other insulin products such as NPH insulin. Always draw the insulin lispro into the syringe first, then follow with the longer-acting insulin. Never inject a mixture of different insulins into a vein. Consult your health care professional about which products may be mixed, the proper method for mixing insulin, and the proper way to inject mixtures of insulin. Do not mix insulins if you are using an insulin pump.

If you are directed to add a mixing liquid to insulin lispro before use (dilute), ask your health care professional about the correct way to dilute insulin.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar levels.

Check your urine/blood sugar levels as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Consumer Overview Side Effect

SIDE EFFECTS: Injection site reactions (such as pain, redness, irritation) may occur. If any of these effects persist or worsen, tell 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.

Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, fast heartbeat, sweating, 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 Humalog (insulin lispro (human analog)) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using insulin lispro, tell your doctor or pharmacist if you are allergic to it; or to other insulins; 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.

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

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

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 using this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

Children may be more sensitive to the side effects of this drug, especially low blood sugar.

Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. 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.

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.

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.

 

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: signs of low blood sugar such as sweating, shakiness, loss of consciousness, fast heartbeat.

 

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 regular medical and laboratory appointments. Laboratory and/or medical tests (such as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor your progress or check for side effects.

Keep extra supplies of insulin, syringes, and needles on hand.

 

MISSED DOSE: It is very important to follow your insulin regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of insulin.

 

STORAGE: Store all unopened insulin products in the refrigerator. Opened insulin lispro vials may be stored in the refrigerator or at room temperature. Opened insulin lispro cartridges and prefilled pens can only be stored at room temperature and should not be refrigerated. Throw away all insulin lispro in use after 28 days, even if there is insulin left. Also throw away all insulin products after the expiration date on the package. Do not freeze and do not use insulin that has been frozen.

If using this drug in an insulin pump, do not store this drug in the pump for more than 7 days. Doing so may lead to ineffective treatment and high blood sugar. Do not expose the insulin in your pump to direct sunlight or temperatures above 98.6 degrees F (37 degrees C).

Protect insulin from light and heat. Do not store in the bathroom. Keep all medications 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.

 

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 March 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Humalog, Humalog Cartridge, Humalog KwikPen, Humalog Pen

Generic Name: insulin lispro (Pronunciation: IN soo lin LISS pro)

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

What is insulin lispro (Humalog)?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting form of insulin.

Insulin lispro is used to treat type 1 (insulin-dependent) diabetes in adults. It is usually given together with another long-acting insulin.

Insulin lispro is also used together with oral (taken by mouth) medications to treat type 2 (non insulin-dependent) diabetes in adults.

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

What are the possible side effects of insulin lispro (Humalog)?

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 lispro. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Insulin lispro can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

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

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Humalog (insulin lispro (human analog)) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about insulin lispro (Humalog)?

Insulin lispro is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also 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, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

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.

Insulin lispro 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
  • Humalog

Patient Detailed How Take

What should I discuss with my healthcare provider before using insulin lispro (Humalog)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin lispro, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin lispro 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.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to be 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 lispro 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 lispro (Humalog)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin lispro is given as an injection (shot) under your skin, using a needle and syringe or an insulin pump. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. 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.

Insulin lispro is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Insulin lispro 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.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

If you use this medication with an insulin pump, do not mix or dilute insulin lispro with any other insulin. Call your doctor at once if you think your infusion pump is not working properly.

Use each disposable needle only one time. 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.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Infusion pump tubing, catheters, and the needle location on your skin should be changed every 48 hours. Throw away any medication leftover in the reservoir.

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.

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

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin lispro dose if needed. Do not change your dose without first talking to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic.

Storing unopened vials, cartridges, or injection pens: 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.

Unopened vials, cartridges, or injection pens 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 in the refrigerator, protected from light. Use within 28 days.

Do not refrigerate an in-use cartridge or injection pen. Keep it at room temperature and use within 28 days.

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

Side Effects Centers
  • Humalog

Patient Detailed Avoid Taking

What happens if I miss a dose (Humalog)?

Since insulin lispro is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin lispro, be sure to eat a meal within 15 minutes. Do not use extra insulin lispro to make up a missed dose.

It is important to keep insulin lispro on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose (Humalog)?

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

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using insulin lispro (Humalog)?

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

Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin lispro.

Do not expose insulin lispro to high heat.

What other drugs will affect insulin lispro (Humalog)?

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;
  • guanethidine (Ismelin); or
  • beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

There are many other medicines that can increase or decrease the effects of insulin lispro on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about insulin lispro.


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: 4.02. Revision date: 12/15/2010.

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
  • Humalog

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