See CONTRAINDICATIONS for information regarding increased mortality in growth hormone treated patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients developing acute critical illnesses should be weighed against the potential risk.

General: Serostim^Ã? LQ [somatropin (rDNA origin) injection] therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of HIV infection. Inadequate nutritional intake, malabsorption and hypogonadism, which are common in individuals with HIV infection and which may contribute to catabolism and weight loss, should be diagnosed and treated.

HIV and Growth Hormone Considerations: In some experimental systems, recombinant human growth hormone (r-hGH) 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 rhGH does not interfere with the antiviral activity of zalcitabine or stavudine. In the controlled clinical trials, no significant growth hormone-associated increase in viral burden was observed. However, the protocol required all participants to be on concomitant antiretroviral 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^Ã? LQ treatment.

Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim^Ã? LQ, 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^Ã? LQ. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim^Ã? LQ, it is recommended that treatment be discontinued.

Patients should be informed that allergic reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. None of the 651 study participants with HIV associated wasting treated with Serostim^Ã? for the first time developed detectable antibodies to growth hormone (> 4 pg binding). Patients were not rechallenged.

Recombinant human growth hormone (r-hGH) has been associated with acute pancreatitis.

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

During post-marketing surveillance, cases of new onset impaired glucose intolerance, 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 patients necessitated initiation or adjustment of antidiabetic treatment while on Serostim..

No cases of intracranial hypertension (IH) have been observed among patients with AIDS wasting treated with Serostim^Ã? . The syndrome of IH, with papilledema, visual changes, headache, and nausea and/or vomiting has been reported in a small number of children with growth failure treated with growth hormone products. Nevertheless, funduscopic evaluation of patients is recommended at the initiation and periodically during the course of Serostim^Ã? therapy.

Kaposis sarcoma, lymphoma, and other malignancies are common in HIV+ individuals. There was no increase in the incidence of Kaposis sarcoma, lymphoma, or in the progression of cutaneous Kaposis sarcoma in clinical studies of Serostim^Ã? . Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenicity have not been performed with Serostim^Ã? LQ. There is no evidence from animal studies to date of Serostim^Ã? LQ -induced mutagenicity or impairment of fertility.

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^Ã? . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Women: It is not known whether Serostim^Ã? LQ is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim^Ã? LQ is administered to a nursing woman.

Pediatric Use: 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 AIDS wasting.

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 growth hormone action, and may be more prone to develop adverse reactions. Thus, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

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