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.

Active Malignancy: In general, 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. 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.

Warnings and 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. However, the protocols required all participants to be on concomitant antiretroviral therapy for the duration of the controlled clinical trials, with no significant somatropin-associated increase in viral burden observed. 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. 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 mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim^®. Some patients developed diabetic ketoacidosis and 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^®.

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.
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 Reaction:
Injection site should be rotated to avoid tissue atrophy. This can be avoided by rotating the injection site. Patient should be informed that such 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 more 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 adults. Pancreatitis should be considered in any somatropin–treated patient who develops abdominal pain.

Adverse Reactions

In clinical trials in HIV-associated wasting or cachexia the most common adverse reactions included (incidence >10%) peripheral edema and musculoskeletal disorders (arthralgia, myalgia, arthritis).

Please see the full Prescribing Information for a complete discussion of Serostim^®'s risks.

Indications and Usage

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. Concomitant antiretroviral therapy is necessary.

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