Serostim® (somatropin) for injection

Important Risk Information

CONTRAINDICATIONS Serostim should not be used in patients with acute critical illness, active malignancy, hypersensitivity to somatropin or any of its excipients, or diabetic retinopathy. Increased mortality has been reported in patients with acute critical illness due to complications following surgery, multiple accidental trauma, or acute respiratory failure. Preexisting malignancies should be inactive and treatment completed prior to instituting therapy. Serostim should be discontinued if there is evidence of tumor recurrence. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products.

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with somatropin.

Concomitant Antiretroviral Therapy: Somatropin has been shown to potentiate HIV replication in vitro, however there was no increase in virus production when antiretroviral agents were added to the culture medium. All patients received antiretroviral therapy for the duration of treatment during Serostim clinical trials and no significant increase in viral burden was observed.

Neoplasms: Patients with preexisting tumors should be monitored for progression or reoccurrence. Monitor patients on somatropin therapy carefully for preexisting nevi.

Impaired Glucose Tolerance/Diabetes: Cases of new onset impaired glucose tolerance, new onset type 2 diabetes, and exacerbation of preexisting diabetes have been reported in patients receiving Serostim. Some patients developed diabetic ketoacidosis and diabetic coma. Patients with risk factors for hyperglycemia and glucose intolerance should be monitored closely and those using antidiabetic agents may require dose adjustment.

Intracranial Hypertension: Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported. Funduscopic examination should be performed prior to initiating treatment with Serostim and periodically during the course of treatment. If papilledema is observed, treatment should be stopped and restarted at a lower dose after IH-associated symptoms have resolved.

Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs.

Fluid Retention/Carpal Tunnel Syndrome: Swelling (particularly in the hands and feet), musculoskeletal discomfort, or carpal tunnel syndrome may occur during treatment with Serostim. Symptoms may resolve spontaneously, with analgesic therapy, or after reducing the frequency of dosing. If symptoms of carpal tunnel do not resolve by decreasing the weekly number of doses, it is recommended that Serostim treatment be discontinued.

Skin Atrophy: Rotate the injection site to avoid tissue atrophy.

Pancreatitis: Cases of pancreatitis have been reported rarely. Consider pancreatitis in patients who develop persistent severe abdominal pain.

ADVERSE REACTIONS

In clinical trials in HIV-associated wasting or cachexia the most common adverse reactions (incidence >10%) were increased tissue turgor, arthralgia, myalgia, and arthrosis, which may be responsive to dose reduction. Other common adverse reactions (incidence >5%) included nausea, fatigue, gynecomastia, paresthesia, generalized edema and hypoesthesia.

SPECIAL POPULATIONS:

Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk. The safety and effectiveness of somatropin in patients with hepatic or renal impairment or in patients aged 65 years and over have not been evaluated in clinical studies.

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