Drugs Details

Drugs Info of Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive
Drugs Details
  • Drugs Type  : FDA
  • Date : 2nd Apr 2015 10:15 pm
  • Brand Name : Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive
  • Generic Name : somatropin (Pronunciation: soe ma TROE pin)
Descriptions

Serostim® is a human growth hormone (hGH) produced by recombinant DNA technology. Serostim® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Serostim® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. Serostim® is secreted directly through the cell membrane into the cell-culture medium for collection and purification.

Serostim® is a sterile lyophilized powder intended for subcutaneous injection after reconstitution to its liquid form.

Vials of Serostim® contain either 4 mg, 5 mg, or 6 mg. Each vial contains the following:

 

  VIALS
4 MG 5 MG 6 MG
Component
Somatropin 4 mg 5 mg 6 mg
Sucrose 27.3 mg 34.2 mg 41 mg
Phosphoric acid 0.9 mg 1.2 mg 1.4 mg

 

Each 4 mg multi-vial is supplied in a combination package with Bacteriostatic Water for Injection, USP. The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.

Each 5 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP (0.9% Benzyl Alcohol). The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution.

Each 6 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.

 

What are the possible side effects of somatropin?

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your...

Read All Potential Side Effects and See Pictures of Serostim »

What are the precautions when taking somatropin (rdna origin) (Serostim)?

Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eye problems (e.g., diabetic retinopathy), major surgery or trauma, severe breathing problems (acute respiratory failure), undergoing therapy for tumors (cancer), Prader-Willi syndrome (see Side Effects section above), normal growth has stopped (closed epiphyses).

Before using this medication, tell your doctor or pharmacist...

Read All Potential Precautions of Serostim »

 

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

Indications

Serostim® [somatropin (rDNA origin) for injection] is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitantantiretroviral therapy is necessary.

Dosage Administration

Serostim® is administered by subcutaneous injection.

Serostim® therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of HIV infection.

HIV-associated wasting or cachexia

The usual starting dose of Serostim® is 0.1 mg/kg subcutaneously once daily (up to a total dose of 6 mg). Serostim® should be administered subcutaneously once daily at bedtime according to the following body weight-based dosage recommendations:

 

WEIGHT RANGE DOSE
>55kg (>121 lb) 6 mg* SC daily
45-55 kg (99-121 lb) 5 mg* SC daily
35-45 kg (75-99 lb) 4 mg* SC daily
<35 kg ( <75 lb) 0.1 mg/kg SC daily
*Based on an approximate daily dosage of 0.1 mg/kg.

 

 

Treatment with Serostim® 0.1 mg/kg every other day was associated with fewer side effects, and resulted in a similar improvement in work output, as compared with Serostim® 0.1 mg/kg daily. Therefore, a starting dose of Serostim® 0.1 mg/kg every other day should be considered in patients at increased risk for adverse effects related to recombinant human growthhormone therapy (i.e., glucose intolerance). In general, dose reductions (i.e., reducing the total daily dose or the number of doses per week) should be considered for side effects potentially related to recombinant human growth hormone therapy.

Most of the effect of Serostim® on work output and lean body mass was apparent after 12 weeks of treatment. The effect was maintained during an additional 12 weeks of therapy. There are no safety or efficacy data available from controlled studies in which patients were treated with Serostim® continuously for more than 48 weeks. There are no safety or efficacy data available from trials in which patients with HIV wasting or cachexia were treated intermittently with Serostim®.

Preparation and Administration

Each vial of Serostim® 5 mg or 6 mg is reconstituted with 0.5 to 1 mL Sterile Water for Injection, USP.

Each vial of Serostim® 4 mg is reconstituted in 0.5 to 1 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved). For patients sensitive to Benzyl Alcohol, Serostim® may be reconstituted with Sterile Water for Injection, USP. [See Pediatric Use]

When Serostim® is reconstituted with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded

When Serostim® is reconstituted with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved) the reconstituted solution may be refrigerated (2-8oC/36-46oF) for up to 14 days.

Approximately 10% mechanical loss can be associated with reconstitution and administration from multi-dose vials.

To reconstitute Serostim®, inject the diluent into the vial of Serostim® aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteraldrug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit SEROSTIM® MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

Serostim® can be administered using (1) a standard sterile, disposable syringe and needle, (2) a compatible Serostim® needle-free injection device or (3) a compatible Serostim® needle injection device. For proper use, refer to the Instructions for Use provided with the administration device. Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation.

How Supplied

Dosage Forms And Strengths

Single-use administration (to be reconstituted with Sterile Water for Injection):

  • Serostim® 5 mg per vial
  • Serostim® 6 mg per vial

Multi-use administration (to be reconstituted with Bacteriostatic Water for Injection):

  • Serostim® 4 mg per vial

Serostim® is available in the following forms:

Serostim® single-use vials containing 5 mg with Sterile Water for Injection, USP. Package of 7 vials. NDC 44087-0005-7

Serostim® single-use vials containing 6 mg with Sterile Water for Injection, USP. Package of 7 vials. NDC 44087-0006-7

Serostim® multiple-use vials containing 4 mg with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). Package of 7 vials. NDC 44087-0004-7

Storage and Handling

Before reconstitution: Vials of Serostim® and diluent should be stored at room temperature, (15°30°C/59°-86°F). Expiration dates are stated on product labels.

Single-use vials: After reconstitution with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded.

Multi-use vials: After reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol), the reconstituted solution should be stored under refrigeration (2-8oC/36-46oF) for up to 14 days.

Avoid freezing reconstituted vials of Serostim®.

Manufactured for: EMD Serono, Inc., Rockland, MA 02370. Revised: April 2012

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

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical trials in HIV-associated wasting or cachexia

In the 12-week, placebo-controlled Clinical Trial 2, 510 patients were treated with Serostim®. The most common adverse reactions judged to be associated with Serostim® were musculoskeletal discomfort and increased tissue turgor (swelling, particularly of the hands or feet), and were more frequently observed when Serostim® 0.1 mg/kg was administered on a daily basis [Table 1 and Warning and Precautions (5.4]). These symptoms often subsided with continued treatment or dose reduction. Approximately 23% of patients receiving Serostim® 0.1 mg/kg daily and 11% of patients receiving 0.1 mg/kg every other day required dose reductions. Discontinuations as a result of adverse reactions occurred in 10.3% of patients receiving Serostim® 0.1 mg/kg daily and 6.6% of patients receiving 0.1 mg/kg every other day. The most common reasons for dose reduction and/or drug discontinuation were arthralgia, myalgia, edema, carpal tunnel syndrome, elevated glucose levels, and elevated triglyceride levels.

Clinical adverse reactions which occurred during the first 12 weeks of study in at least 5% of the patients in either active treatment group and at an incidence greater than placebo are listed below, without regard to causality assessment.

Table 1: Controlled Clinical Trial 2 Adverse Reactions Occurring in at least 5% of Patients in one of the Treatment Groups, and at an Incidence Greater than Placebo

  PLACEBO 0.1 MG/KG EVERY OTHER DAY SEROSTIM® 0.1 MG/KG DAILY SEROSTIM®
BODY SYSTEM PREFERRED TERM PATIENTS (N=247) 
%
PATIENTS 
(N=257)
%
PATIENTS 
(N=253) 
%
Musculoskeletal System Disorders
  Arthralgia 11.3 24.5 36.4
  Myalgia 11.7 17.9 30.4
  Arthrosis 3.6 7.8 10.7
Gastrointestinal System Disorders
  Nausea 4.9 5.4 9.1
Body As A Whole - General Disorders
  Edema Peripheral 2.8 11.3 26.1
  Fatigue 4.5 3.5 5.1
Endocrine Disorders
  Gynecomastia 0.4 3.5 5.5
Central & Peripheral Nervous System Disorders
  Paresthesia 4.5 7.4 7.9
  Hypoesthesia 2.4 1.6 5.1
Metabolic And Nutritional Disorders
  Edema Generalized 1.2 1.2 5.9

 

Adverse reactions that occurred in 1% to less than 5% of trial participants receiving Serostim® during the first 12 weeks of Clinical Trial 2 thought to be related to Serostim® included dose dependent edema, periorbital edema,carpal tunnel syndrome, hyperglycemia and hypertriglyceridemia.

During the 12-week, placebo-controlled portion of Clinical Trial 2, the incidence of hyperglycemia reported as an adverse reaction was 3.6% for the placebo group, 1.9% for the 0.1 mg/kg every other day group and 3.2% for the 0.1 mg/kg daily group. One case of diabetes mellitus was noted in the 0.1 mg/kg daily group during the first 12-weeks of therapy. In addition, during the extension phase of Clinical Trial 2, two patients converted from placebo to full dose Serostim®, and 1 patient converted from placebo to half-dose Serostim®, were discontinued because of the development of diabetes mellitus.

The types and incidences of adverse reactions reported during the Clinical Trial 2 extension phase were not different from, or greater in frequency than those observed during the 12-week, placebo-controlled portion of Clinical Trial 2.

Adverse reactions from treatment with Serostim® in clinical trials in HIV lipodystrophy

Serostim® was evaluated for the treatment of patients with HIV lipodystrophyin two double-blind, placebo-controlled trials that excluded patients with a history of diabetes, impaired fasting glucose or impaired glucose (approximately 20% of the patients screened were excluded from study enrollment as a result of a diagnosis of diabetes or glucose intolerance). The studies included a 12-week double-blind, placebo-controlled, parallel group “induction” phase followed by maintenance phases of different durations (12 and 24 weeks, respectively). In the initial 12-week treatment periods of the two, placebo-controlled clinical trials, 406 patients were treated with Serostim®. Clinical adverse reactions which occurred during the first 12 weeks of both studies combined in at least 5% of the patients in either of the two active treatment groups are listed by treatment group in Table 2, without regard to causality assessment. The most common adverse reactions judged to be associated with Serostim® were edema, arthralgia, pain in extremity, hypoesthesia, myalgia, and blood glucose increased, all of which were more frequently observed when Serostim® 4 mg was administered on a daily basis compared with alternate days. These symptoms often subsided with dose reduction. During the 12-week induction phase, 1) approximately 26% of patients receiving Serostim®4 mg daily and 19% of patients receiving Serostim® 4 mg every other day required dose reductions; and 2) discontinuations as a result of adverse reactions occurred in 13% of patients receiving Serostim® 4 mg daily and 5% of patients receiving Serostim® 4 mg every other day. The most common reasons for dose reduction and/or drug discontinuation were peripheral edema, hyperglycemia (including blood glucose increased, blood glucose abnormal, and hyperglycemia), and arthralgia.

Table 2: Controlled HIV Lipodystrophy Studies 1 and 2 Combined – Adverse Reactions with >5% Incidence in Either Active Treatment Arm

SYSTEM ORGAN CLASS PREFERRED TERM PLACEBO SEROSTIM® 4 MG EVERY OTHER DAY1 SEROSTIM ≥ 4 MG DAILY
PATIENTS 
(N=159) 
%
PATIENTS 
(N=80)
%
PATIENTS 
(N=326)
%
Musculoskeletal and connective tissue disorders
  Arthralgia 11.9 27.8 37.1
  Pain in extremity 3.8 5 19.3
  Myalgia 3.8 2.5 12.6
  Musculoskeletal stiffness 1.9 3.8 8
  Joint stiffness 1.3 3.8 7.7
  Joint swelling 0.6 5 6.1
General disorders and administration site conditions
  Edema peripheral 3.8 18.8 45.4
  Fatigue 1.9 6.3 8.9
Nervous system disorders
  Hypoesthesia 0.6 8.8 15
  Paraesthesia 2.5 12.5 11
Investigations (Laboratory Evaluations)
  Blood glucose increased2 2.5 3.8 13.8
Metabolism and nutrition disorders
  Hyperglycemia2 0.6 8.8 7.1
  Fluid retention 0.6 2.5 5.2
Gastrointestinal disorders
  Nausea 2.5 1.3 6.1
1Study 22388 only 
2similar terms were grouped together and reported below

 

Glucose metabolism related adverse reactions: During the initial 12-week treatment periods of Studies 1 and 2, the incidence of glucose-related adverse reactions was 4% for the placebo group, 13% for the 4 mg every other day group and 22% for the 4 mg daily group.

'Twenty-three patients discontinued due to hyperglycemia while receiving Serostim® during any phase of these studies (3.2% in the 12-week induction phases and 2.1% in the extension phases)'.

Breast-Related Terms: When grouped together, breast-related adverse reactions (e.g. nipple pain, gynecomastia, breast pain/mass/tenderness/swelling/edema/hypertrophy) had an incidence of 1% for the placebo group, 3% for the Serostim® 4 mg every other day group and 6% for the Serostim® 4 mg daily group.

Adverse reactions that occurred in 1% to less than 5% of trial participants receiving Serostim® during the first 12 weeks of HIV Lipodystrophy Studies 1 and 2 thought to be related to Serostim® include carpal tunnel syndrome,Tinel's sign and facial edema.

The adverse reactions reported for Serostim® 4 mg every other day during the maintenance phase of HIV Lipodystrophy Study 1 (Week 12 to Week 24) were similar in frequency and quality to those observed after treatment with Serostim® 4 mg every other day during the 12-week induction phase.

IGF-1 serum concentrations increased statistically in Serostim®-treated patients when compared to placebo (Table 6). In the Serostim® treated patients at baseline, the proportion of subjects with serum

IGF-1 SDS levels ≥ +2 was approximately 10 to 20%, while with treatment with either dose regimen of Serostim® the percentage increased to 80 to 90% by Weeks 12.

Table 3: Change from Baseline to Week 12 in Serum IGF-1 SDS After Treatment with Serostim® 4 mg daily vs. Placebo (Modified ITT Population; Studies 1and 2 Combined)

TIME POINT STATISTIC PLACEBO
(N=145)
SEROSTIM® 4 MG EVERY OTHER DAY
(N=79)
SEROSTIM® 4 MG DAILY 
(N=290)
Baseline Mean (SD) 0.4 (1.4) 1.3 (2.1) 0.0 (1.6)
  Range (-2.5, 4.8) (-2.0, 13.7) (-3.0, 11.9)
Week 12 Mean (SD) 0.8 (1.6) 5.1 (3.4) 6.1 (5.0)
  Range (-2.6, 6.7) (-0.7, 17.2) (-1.8, 29.2)
Change from Mean (SD) 0.4 (1.3) 3.9 (3.1) 6.1 (4.6)
Baseline to Range (-2.9, 7.7) (-9.4, 11.8) (-2.4, 24.3)
Week 12 p-valueb <0.001 <0.001 <0.001
Meana diff (SEM)   3.5 (0.5) 5.7 (0.4)
p-valuec   <0.001 <0.001
a Proportionally weighted least squares means from a two-way ANOVA model on raw data including effects for treatment, sex, and the treatment by sex interaction. 
b P-value from a Wilcoxon Signed Rank test on the change from baseline to Week 12. 
c P-value from a two-way ANOVA model on ranked data including effects for treatment, sex, and the treatment by sex interaction.

 

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influences by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Serostim® with the incidence of antibodies to other products may be misleading.

After 12 weeks of treatment, none of the 651 study participants with HIV-associated wasting treated with Serostim® for the first time developed detectable antibodies to growth hormone (> 4 pg binding). Patients were not rechallenged. Data beyond 3 months is not available.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Serostim®. 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.

Endocrine
  • new onset impaired glucose tolerance
  • new onset type 2 diabetes mellitus
  • exacerbation of preexisting diabetes mellitus
  • diabetic ketoacidosis
  • diabetic coma

In some patients, these conditions improved when Serostim® was discontinued, while in others the glucose intolerance persisted. Some of these patients required initiation or adjustment of antidiabetic treatment while on Serostim®.

Gastrointestinal-Pancreatitis. Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment [seeWARNINGS AND PRECAUTIONS].

Read the Serostim (somatropin (rdna origin)) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Formal drug interaction studies have not been conducted. No data are available on drug interactions between Serostim® and HIV proteaseinhibitors or the non-nucleoside reverse transcriptase inhibitors.

11β-Hydroxysteroid Dehydrogenase Type 1

The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite,cortisol, in hepatic and adipose tissue. Somatropin inhibit 11βHSD-1. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

Cytochrome P450-metabolized drugs

Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds metabolized by CP450 liver enzymes (e.g., corticosteroids, six steroids, anticonvulsants, cyclosporine). Therefore, careful monitoring is advised when somatropin is administered in combination with drugs metabolized by CP450 liver enzymes. However, formal drug interaction studies have not been conducted.

Oral Estrogen

Because oral estrogens may reduce the serum IGF-1 response to somatropin treatment, girls and women receiving oral estrogen replacement may require greater somatropin dosages [see DOSAGE AND ADMINISTRATION].

Insulin and/or Other Oral/Injectable Hypoglycemic Agents

Patients with diabetes mellitus who receive concomitant treatment with somatropin may require adjustment of their doses of insulin and/or other hypoglycemic agents [see WARNINGS AND PRECAUTIONS].

Read the Serostim 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

Concomitant Antiretroviral Therapy

In some experimental systems, somatropin has been shown to potentiate HIV replication in vitro at concentrations ranging from 50-250 ng/ml. There was no increase in virus production when the antiretroviral agents, zidovudine, didanosine or lamivudine were added to the culture medium. Additional in vitro studies have shown that somatropin does not interfere with the antiviral activity of zalcitabine or stavudine. In the controlled clinical trials, no significant somatropin-associated increase in viral burden was observed. However, the protocol required all participants to be on concomitantantiretroviral therapy for the duration of the study. In view of the potential for acceleration of virus replication, it is recommended that HIV patients be maintained on antiretroviral therapy for the duration of Serostim® treatment.

Impaired Glucose Tolerance/Diabetes

Hyperglycemia may occur in HIV infected individuals due to a variety of reasons. In wasting patients, treatment with Serostim® 0.1 mg/kg daily and 0.1 mg/kg every other day for 12 weeks was associated with approximately 10 mg/dL and 6 mg/dL increases in mean fasting blood glucoseconcentrations, respectively. The increases occurred early in treatment. Patients with other risk factors for glucose intolerance should be monitored closely during Serostim® therapy.

During safety surveillance of patients with HIV-associated wasting, cases of new onset impaired glucose tolerance, new onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim®. Some patients developed diabetic ketoacidosisand diabetic coma. In some patients, these conditions improved when Serostim® was discontinued, while in others, the glucose intolerance persisted. Some of these patients required initiation or adjustment of antidiabetic treatment while on Serostim®.

In clinical trials of Serostim® conducted in HIV patients with lipodystrophy (an unapproved indication), evidence of dose-dependent glucose intolerance and related adverse reaction was observed at doses of 4 mg Serostim® daily and 4 mg Serostim® every other day for 12 weeks (Refer to Section 6.1).

Intracranial Hypertension

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin products. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved.

Fluid Retention/Carpal Tunnel Syndrome

Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim®, but may resolve spontaneously, with analgesic therapy, or after reducing the frequency of dosing [see DOSAGE AND ADMINISTRATION].

Carpal tunnel syndrome may occur during treatment with Serostim®. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim®, it is recommended that treatment be discontinued.

Local and Systemic Reactions

When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site [see DOSAGE AND ADMINISTRATION]. As with any protein, local or systemic allergic reactions may occur. Patients should be informed that allergic reactions are possible and that prompt medical attention should be sought if allergic reactions occur.

Kaposi's sarcoma, Lymphoma and other Malignancies

Kaposi's sarcoma (KS), lymphoma, and other malignancies are common in HIV+ individuals. There was no increase in the incidence of Kaposi's sarcoma, lymphoma, or in the progression of cutaneous Kaposi's sarcoma in clinical studies of Serostim®. Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.

Pancreatitis

Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin-treated patient, especially a child who develops abdominal pain.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies for carcinogenicity have not been performed with Serostim®. There is no evidence from animal studies to date of Serostim®-induced mutagenicity or impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Doses up to 5 to 10 times the human dose, based on body surface area, have revealed no evidence of impaired fertility or harm to the fetus due to Serostim®. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Serostim® should be used during pregnancy only if clearly needed.

Nursing Women

It is not known whether Serostim® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients with HIV have not been established. Available evidence suggests that somatropin clearance is similar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV.

In two small studies, 11 children with HIV-associated failure to thrive were treated subcutaneously with human growth hormone. In one study, five children (age range, 6 to 17 years) were treated with 0.04 mg/kg/day for 26 weeks. In a second study, six children (age range, 8 to 14 years) were treated with 0.07 mg/kg/day for 4 weeks. Treatment appeared to be well tolerated in both studies. The preliminary data collected on a limited number of patients with HIV-associated failure to thrive appear to be consistent with safety observations in growth hormone-treated adults with HIV wasting.

Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates. Additional symptoms may include gradual neurologicaldeterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

Geriatric Use

Clinical studies with Serostim® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more sensitive to the action of somatropin, and therefore, may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see DOSAGE AND ADMINISTRATION].

Hepatic Impairment

No studies have been conducted for Serostim® in patients with hepatic impairment [see CLINICAL PHARMACOLOGY].

Renal Impairment

Subjects with chronic renal failure tend to have decreased somatropin clearance compared to those with normal renal function. However, no studies have been conducted for Serostim® in patients with renal impairment [see CLINICAL PHARMACOLOGY].

Gender Effect

Biomedical literature indicates that a gender-related difference in the mean clearance of r-hGH could exist (clearance of r-hGH in males > clearance of r-hGH in females). However, no gender-based analysis is available for Serostim® in normal volunteers or patients infected with HIV.

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

 
 

OverDose

Short-Term

Acute overdosage could lead initially to hypoglycemia and subsequently tohyperglycemia.

Long-Term

Long-term overdosage could result in signs and symptoms of acromegalyconsistent with the known effects of excess growth hormone.

ContrainDications

Acute Critical Illness

Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo [see WARNING AND PRECAUTIONS].

Active Malignancy

In general, somatropin is contraindicated in the presence of activemalignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity.

Diabetic Retinopathy

Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Hypersensitivity

Serostim® is contraindicated in patients with a known hypersensitivity to somatropin or diluent.

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

Clinical Pharamacology

Mechanism of action

Serostim® is an anabolic and anticatabolic agent which exerts its influence by interacting with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some, but not all of its effects, are mediated by insulin-like growth factor-1 (IGF-1).

Pharmacodynamics

Effects on Protein, Lipid and Carbohydrate Metabolism

A one-week study in 6 patients with HIV-associated wasting has shown that treatment with Serostim® 0.1 mg/kg/day improved nitrogen balance, increased protein-sparing lipid oxidation, and had little effect on overall carbohydrate metabolism.

Decreases in trunk fat and total body fat, and increases in lean body masswere observed during two double-blind, placebo-controlled studies wherein Serostim® vs. placebo were administered daily for 12 weeks to patients with HIV Lipodystrophy [see Clinical Studies].

Effects on Nitrogen and Mineral Retention

In the one-week study in 6 patients with HIV-associated wasting, treatment with Serostim® resulted in the retention of phosphorous, potassium, nitrogen, and sodium. The ratio of retained potassium and nitrogen during Serostim® therapy was consistent with retention of these elements in lean tissue.

Physical Performance

Cycle ergometry work output and treadmill performance were examined in separate 12-week, placebo-controlled trials [see Clinical Studies]. In both studies, work output improved significantly in the group receiving Serostim® 0.1 mg/kg/day subcutaneously vs placebo. Isometric muscle performance, as measured by grip strength dynamometry, declined, probably as a result of a transient increase in tissue turgor known to occur with Serostim® therapy.

Pharmacokinetics

Absorption

The absolute bioavailability after subcutaneous was determined to be 70 to 90%. The mean t½ after subcutaneous administration is significantly longer than that seen after intravenous administration in normal male volunteers down-regulated with somatostatin (approximately 4.0 hrs. vs. 0.6 hrs.), indicating that the subcutaneous absorption of somatropin is a rate-limiting process.

Distribution

The steady-state volume of distribution (Mean ± SD) following intravenous administration of somatropin in normal male volunteers is 12.0 ± 1.08 L.

Metabolism

Although the liver plays a role in the metabolism of GH, GH is primarily cleaved in the kidney. GH undergoes glomerular filtration and, after cleavage within the renal cells, the peptides and amino acids are returned to the systemic circulation.

Elimination

The t½ in nine patients with HIV-associated wasting with an average weight of 56.7 ± 6.8 kg, given a fixed dose of 6.0 mg somatropin subcutaneously was 4.28 ± 2.15 hrs, similar to that observed in normal male volunteers. The renal clearance of r-hGH after subcutaneous administration in nine patients with HIV-associated wasting was 0.0015 ± 0.0037 L/h. No significant accumulation of r-hGH appears to occur after 6 weeks of daily dosing as indicated.

Specific Populations

Pediatric: Available evidence suggests that r-hGH clearances are similar in adults and children, but no pharmacokinetic studies have been conducted in children with HIV.

Gender: Biomedical literature indicates that a gender-related difference in the mean clearance of r-hGH could exist (clearance of r-hGH in males > clearance of r-hGH in females). However, no gender-based analysis is available in normal volunteers or patients infected with HIV.

Race: No studies have been conducted to determine the effect of race on the pharmacokinetics of Serostim®.

Renal Impairment: Subjects with chronic renal failure tend to have decreased somatropin clearance compared to those with normal renal function. However, no studies have been conducted to determine the effect of renal impairment on the pharmacokinetics of Serostim®.

Hepatic Impairment: No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetic of Serostim®.

Clinical Studies

HIV-Associated Wasting or Cachexia

The clinical efficacy of Serostim® in HIV-associated wasting or cachexia was assessed in two placebo-controlled trials. All study subjects received concomitant antiretroviral therapy.

Clinical Trial 1

A 12-week, randomized, double-blind, placebo-controlled study followed by an open-label extension phase enrolled 178 patients with severe HIV wasting taking nucleoside analogue therapy (pre-HAART era). The primary endpoint was body weight. Body composition was assessed using dual energy X-rayabsorptiometry (DXA) and physical function was assessed by treadmill exercise testing. Patients meeting the inclusion/exclusion criteria were treated with either placebo or Serostim® 0.1 mg/kg daily. Ninety-six percent (96%) were male. The average baseline CD4 count/microliterL was 85. The results from one hundred forty (140) evaluable patients were analyzed (those completing the 12-week course of treatment and who were at least 80% compliant with study drug). After 12 weeks of therapy, the mean difference in weight increase between the Serostim®-treated group and the placebo-treated group was 1.6 kg (3.5 lb). Mean difference in lean body mass (LBM) change between the Serostim®-treated group and the placebo-treated group was 3.1 kg (6.8 lbs) as measured by DXA. Mean increase in weight and LBM, and mean decrease in body fat, were significantly greater in the Serostim®-treated group than in the placebo group (p=0.011, p <0.001, p <0.001, respectively) after 12 weeks of treatment (Figure 1). There were no significant changes with continued treatment beyond 12 weeks suggesting that the original gains of weight and LBM were maintained (Figure 1).

Treatment with Serostim® resulted in a significant increase in physical function as assessed by treadmill exercise testing. The median treadmill work output increased by 13% (p=0.039) at 12 weeks in the group receiving Serostim® (Figure 2). There was no improvement in the placebo-treated group at 12 weeks. Changes in treadmill performance were significantly correlated with changes in LBM.

Figure 1: Mean Changes in Body Composition

View Enlarged Table

 

Figure 2: Median Treadmill Work Output

SEROSTIM®  [somatropin (rDNA origin) for injection] Figure 2 Illustration

 

*p = 0.039

Clinical Trial 2

A 12-week, randomized, double-blind, placebo-controlled study enrolled 757 patients with HIV-associated wasting, or cachexia. The primary efficacy endpoint was physical function as measured by cycle ergometry work output. Body composition was assessed using bioelectrical impedance spectroscopy (BIS) and also by dual energy X-ray absorptiometry (DXA) at a subset of centers. Patients meeting the inclusion/exclusion criteria were treated with either placebo, approximately 0.1 mg/kg every other day (qod) of Serostim®, or approximately 0.1 mg/kg daily at bedtime of Serostim®. All results were analyzed in intent-to-treat populations (for cycle ergometry work output, n=670). Ninety-one percent (91%) were male and 88% were on HAART anti-retroviral therapy. The average baseline CD4 count/μL was 446. Six hundred forty-six patients (646) completed the 12-week study and continued in the Serostim® treatment extension phase of the trial.

Clinical Trial 2 results are summarized in Tables 4 and 5:

Table 4: Mean (Median) of Cycle Work Output (kJ) Response after 12 weeks of Treatment ITT Population

  PLACEBO HALF-DOSE SEROSTIMB FULL-DOSE SEROSTIMA
Cycle work output (kJ) n=222 n=230 n=218
Baseline 25.92 (25.05) 27.79 (26.65) 27.57 (26.30)
Change from baseline -0.05 (-0.25) 2.48 (2.30) 2.52 (2.40)
Percent change from baseline 0.20% 8.90% 9.10%
Difference from Placebo
Mean (2-sided 95% C.I.) - 2.53c (0.81, 4.25) 2.57c(0.83, 4.31)
Median   2.55 2.65
a approximately 0.1 mg/kg daily 
b approximately 0.1 mg/kg every other day 
c p <0.01

 

Table 5: Mean (Median) Change from Baseline for Lean Body Mass, Fat Mass and Body Weight

  PLACEBO HALF-DOSE SEROSTIMB FULL-DOSE SEROSTIMA
N MEAN (MEDIAN) N MEAN (MEDIAN) N MEAN (MEDIAN)
Lean body mass (kg) (by BIS) 222 0.97 (0.67) 223 3.89 (3.65) 205 5.84 (5.47)
Fat mass (kg) (by DXA) 94 0.03 (0.01) 100 -1.25 (-1.23) 85 -1.72 (-1.51)
Body weight (kg) 247 0.69 (0.68) 257 2.18 (2.15) 253 2.79 (2.65)
a approximately 0.1 mg/kg daily 
b approximately 0.1 mg/kg every other day

 

The mean maximum cycle work output until exhaustion increased after 12 weeks by 2.57 kilojoules (kJ) in the Serostim® 0.1 mg/kg daily group (p <0.01) and by 2.53 kJ in the Serostim® 0.1 mg/kg every other day group (p <0.01) compared with placebo (Table 1). Cycle work output improved approximately 9% in both active treatment arms and decreased <1% in the placebo group. Lean body mass (LBM) and body weight (BW) increased, and fat mass decreased, in a dose-related fashion after treatment with Serostim® and placebo (Table 2). The LBM results obtained by BIS were confirmed with DXA.

Patients' perceptions of the impact of 12 weeks of treatment on their wasting symptoms as assessed by the Bristol-Meyers Anorexia/Cachexia Recovery Instrument improved with both doses of Serostim® in Clinical Trial 2.

Extension Phase: All patients (n=646) completing the 12-week placebo-controlled phase of Clinical Trial 2 continued Serostim® treatment into an extension phase. Five hundred and forty eight of these patients completed an additional 12 weeks of active treatment. In these patients, changes in cycle ergometry work output, LBM, BW, and fat mass either improved further or were maintained with continued Serostim® treatment.

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

Patient Information

Patients being treated with Serostim® should be informed of the potential benefits and risks associated with treatment. Patients should be instructed to contact their physician should they experience any side effects or discomfort during treatment with Serostim®.

It is recommended that Serostim® be administered using sterile, disposable syringes and needles. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes. An appropriate container for the disposal of used syringes and needles should be employed.

Patients should be instructed to rotate injection sites to avoid localized tissueatrophy.

Never Share a Serostim® Pen or Needle Between Patients

Counsel patients that they should never share Serostim or Serostim injection devices with another person, even if the needle or nozzle is changed. Sharing of Serostim or Serostim injection devices between patients may pose a risk of transmission of infection.

Patients should be informed about the management of common side effects relating tissue turgor, glucose intolerance and musculoskeletal discomfort.

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.

 

SOMATROPIN - INJECTION

 

(so-mah-TROW-pin)

 

COMMON BRAND NAME(S): Genotropin, Humatrope, Norditropin, Nutropin, Serostim, Zorbtive

 

USES: Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting.

Somatropin is also used to increase height in children with a certain genetic disorder (Noonan syndrome).

 

HOW TO USE: Read the Patient Information Leaflet that may come with your brand of this medication provided by your pharmacist before you start using somatropin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Some brands of this medication are given by injection into a muscle or under the skin. Some brands may only be injected under the skin. The way you inject this medicine will depend on the brand that you are using. Check with your pharmacist to ensure that the way you are injecting your medicine is correct. It is important to change the location of the injection site to avoid problem areas under the skin. For best results, this medication must be used exactly as prescribed by your doctor. It is important to understand your therapy and to follow your doctor's instructions closely.

The dosage is based on your age, weight, medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake while mixing the solution. Shaking makes the medication not work properly. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If this medicine is used for short bowel syndrome, consult your doctor if a special diet (high carbohydrate/lowfat) or the use of nutritional supplements may be helpful.

If this medicine is used for weight loss/muscle wasting, it may take up to 2 weeks to notice the effects of the drug. Do not use more of this medication than prescribed or use it more often since the risk of side effects will be increased.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, nausea, vomiting, fatigue, muscle pain, or weakness may occur. If these symptoms continue or become bothersome, inform 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: development of a limp, persistent fatigue, unusual/unexplained weight gain, persistent cold intolerance, persistent slow heartbeat, fast heartbeat, ear pain/itching, hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in thirst or urination, swelling hands/ankles/feet, change in the appearance or size of any mole, severe headache, persistent nausea/vomiting, severe stomach/abdominal pain, vision problems or changes, seizure.

Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( e.g., sleep apnea, lung infections, lung disease). Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment. Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction. Tell the doctor immediately if these signs occur. Also report any signs of lung infection, such as fever, persistent cough, or trouble breathing.

A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/severe swelling (especially of the face/tongue/throat), 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 Serostim (somatropin (rdna origin)) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eye problems (e.g., diabetic retinopathy), major surgery or trauma, severe breathing problems (acute respiratory failure), undergoing therapy for tumors (cancer), Prader-Willi syndrome (see Side Effects section above), normal growth has stopped (closed epiphyses).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, diabetes or family history of diabetes, obesity, kidney disease, tumors (cancer), thyroid problems, back problems (scoliosis), a certain genetic condition (Turner syndrome).

If you have diabetes, this drug may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst or urination. Your doctor may need to adjust your diabetes medication.

When this medication is given to newborns, mix with sterile water for injection that does not contain a preservative. A preservative (benzyl alcohol) which may be found in the liquid used to mix this product can infrequently cause serious problems (sometimes death), if given by injection to an infant during the first months of life. The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor immediately should they occur.

Older adults may be more sensitive to the side effects of this drug, especially effects on blood sugar, or swelling ankles/feet.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before 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.

Some products that may interact with this drug include: estrogen hormone replacement, glucocorticoids (e.g., prednisone, hydrocortisone).

 

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 severe headache, nausea, or vomiting; sudden onset of sweating, fatigue, shakiness, confusion (hypoglycemia); or persistent swelling of hands and feet.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., eye exams, thyroid function tests, glucose levels, growth hormone antibody levels) will be done routinely to monitor your response to the medication or check for side effects. Keep all medical appointments and laboratory visits so your therapy can be monitored closely. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. 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.

 

Information last revised January 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive

Generic Name: somatropin (Pronunciation: soe ma TROE pin)

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

What is somatropin (Serostim)?

 

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.

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

What are the possible side effects of somatropin?

 

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;
  • sudden and severe pain behind your eyes, vision changes;
  • swelling in your head, face, hands, or feet; or
  • numbness or tingling in your wrist, hand, or fingers.

Less serious side effects may include:

  • headache, feeling tired;
  • redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;
  • pain in your arms or legs, joint stiffness or pain;
  • muscle pain; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Serostim (somatropin (rdna origin)) Side Effects Center for a complete guide to possible side effects

Learn More »
 

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

 

Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.

Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.

If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

Side Effects Centers
  • Genotropin
  • Humatrope
  • Nutropin
  • Nutropin AQ
  • Serostim
  • Tev-Tropin
  • Omnitrope
  • Saizen
  • Norditropin

Patient Detailed How Take

What should I discuss with my healthcare provider before using somatropin?

 

Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.

You should not use this medication if you are allergic to somatropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);
  • cancer; or
  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use somatropin if you have a serious medical condition after having:

  • open heart surgery or stomach surgery;
  • trauma or other medical emergency; or
  • breathing problems (such as lung failure).

To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease (or if you are on dialysis);
  • diabetes;
  • a pituitary gland disorder;
  • scoliosis;
  • high blood pressure (hypertension);
  • a pancreas disorder (especially in children);
  • a history of cancer;
  • carpal tunnel syndrome;
  • underactive thyroid; or
  • a brain tumor or lesion.

FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive.

FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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

How should I use somatropin?

 

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

Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or 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.

Use a different place on your body 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. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.

Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

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.

To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.

If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.

If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.

How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any somatropin left over after the expiration date on the label has passed.

Side Effects Centers
  • Genotropin
  • Humatrope
  • Nutropin
  • Nutropin AQ
  • Serostim
  • Tev-Tropin
  • Omnitrope
  • Saizen
  • Norditropin

Patient Detailed Avoid Taking

What happens if I miss a dose?

 

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.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using somatropin?

 

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

What other drugs will affect somatropin?

 

Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.

Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted.Do not stop using a steroid suddenly. Follow your doctor's instructions.

Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.

This list is not complete and other drugs may interact with somatropin. 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 somatropin.


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: 12.01. Revision date: 8/10/2011.

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
  • Genotropin
  • Humatrope
  • Nutropin
  • Nutropin AQ
  • Serostim
  • Tev-Tropin
  • Omnitrope
  • Saizen
  • Norditropin

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