INDICATION

Serostim® (somatropin) for injection is indicated for the treatment of adults with HIV and wasting or cachexia to increase lean body mass and body weight and improve physical endurance. Concomitant antiretroviral therapy is necessary.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Acute Critical Illness:  Serostim® (somatropin) 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.

Active Malignancy: Somatropin is contraindicated in the presence of active malignancy.  Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Discontinue somatropin if there is evidence of recurrent activity.

Hypersensitivity: Serostim® is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported.

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

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Increased mortality (42% vs 19% in somatropin compared to placebo treated) 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 pharmacologic amounts of somatropin.

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

Neoplasms: Patients with preexisting tumors should be monitored for progression or reoccurrence. Monitor patients on somatropin therapy carefully for changes of preexisting nevi. Patients without preexisting tumors should be monitored for development of neoplasms if somatropin therapy is initiated.

Impaired Glucose Tolerance/Diabetes: Patients with other risk factors for glucose intolerance should be monitored closely during Serostim® therapy. 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 and, in some, improved when Serostim® was discontinued and in others persisted. Some of these patients required initiation or adjustment of antidiabetic treatment while on Serostim®.

Intracranial Hypertension: Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported usually within the first 8 weeks of somatropin therapy and rapidly resolved after stopping or reducing the somatropin dose. Fundoscopic examination should be performed routinely prior to initiating treatment with somatropin and periodically during 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 post-marketing 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: 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. Carpal tunnel syndrome may occur and if the symptoms of carpal tunnel do not resolve by decreasing the weekly number of doses, it is recommended that Serostim® treatment be discontinued.

Lipoatrophy: 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 >5%) were arthralgia, myalgia, peripheral edema, arthrosis, paresthesia, nausea, fatigue, gynecomastia, hypoesthesia, and generalized edema.

SPECIAL POPULATIONS: 

Pregnancy and Lactation: Somatropin should only be used during pregnancy if, as determined by a qualified healthcare provider, is clearly needed and with caution in nursing mothers because it is not known whether somatropin is present in human milk.

Pediatric Use: The safety and effectiveness of somatropin in pediatric patients with HIV has not been established.

Geriatric Use: Clinical studies did not include sufficient numbers of subjects ≥ 65 to determine a response different from that of younger patients.

Renal Impairment: Studies have not been conducted in patients with renal impairment.

Gender Effect: Gender-based analysis is not available.

Please see full Prescribing Information for a complete discussion on Serostim® safety information.