Serostim Warnings, Precautions, Pregnancy, Nursing, Abuse - Somatropin (rDNA origin)

Serostim Warnings, Precautions, Pregnancy, Nursing, Abuse - Somatropin (rDNA origin)

WARNING

Benzyl Alcohol as a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in newborns. If sensitivity to the diluent occurs, Serostim^® [somatropin (rDNA origin) for injection] may be reconstituted with Sterile Water for Injection, USP. When Serostim^® is reconstituted in this manner, the reconstituted solution should be used immediately and any unused portion should be discarded.

See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or with 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 having acute critical illnesses should be weighed against the potential risk.

General: Serostim^® [somatropin (rDNA origin) for injection] therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of AIDS. Inadequate nutritional intake, malabsorption and hypogonadism, which are common in individuals with AIDS and which may contribute to catabolism and weight loss, should also be monitored 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 r-hGH 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 nucleoside analogue 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 nucleoside analogue therapy for the duration of Serostim^® 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^®, 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^®. 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. 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 188 study participants with AIDS wasting who were evaluable for antibody assessments and who were treated with Serostim^® 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. Serostim^® use was associated with a minimal increase of mean blood glucose concentration. Patients with other risk factors for glucose intolerance should be monitored closely during Serostim^® therapy.

During post-marketing surveillance, cases of new onset glucose intolerance, 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^®. 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^® therapy.

Kaposi’s sarcoma, lymphoma, and other malignancies are 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.

Information For Patients: Patients being treated with Serostim^® should be informed of the potential benefits and risks associated with treatment. Patients should be instructed to contact their physician should they experience any side effects or discomfort during treatment with Serostim^®.

It is recommended that Serostim^® be administered using sterile, disposable syringes and needles. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes. An appropriate container for the disposal of used syringes and needles should be employed.

Patients should be instructed to rotate injection sites to avoid localized tissue atrophy.