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Serostim

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Serostim

Serostim Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Serostim [somatropin (rDNA origin) for injection] 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, short stature at birth with no catch-up growth, and other causes. It is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome. It is a form of human growth hormone. Common side effects include headache, nausea, vomiting, fatigue, muscle pain, or weakness.

The usual starting dose of Serostim is 0.1 mg/kg subcutaneously once daily (up to a total dose of 6 mg) at bedtime. Serostim may interact with insulin or oral diabetes medicine, steroids, cyclosporine, seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women. Tell your doctor all medications you use. Serostim should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Serostim [somatropin (rDNA origin) for injection] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Serostim in Detail - Patient Information: Side Effects

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 entire detailed patient monograph for Serostim (Somatropin (rDNA origin)) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Serostim Overview - Patient Information: Side Effects

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 entire patient information overview for Serostim (Somatropin (rDNA origin))»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Serostim FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 lipodystrophy in 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

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 [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Serostim (Somatropin (rDNA origin)) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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