Somatropindosage

SEROSTIM is administered by subcutaneous injection. SEROSTIM therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of HIV infection. The recommended dosage of SEROSTIM is 0.1 mg/kg subcutaneously once daily (up to 6 mg) at bedtime Injection sites, which may be located on thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation

2.1 HIV-associated wasting or cachexia

The usual starting dose of SEROSTIM is 0.1 mg/kg subcutaneously once daily (up to a total dose of 6 mg). SEROSTIM should be administered subcutaneously once daily at bedtime according to the following body weight-based dosage recommendations: Weight Range Dose >55kg (>121 lb) 6 mg Based on an approximate daily dosage of 0.1 mg/kg. subcutaneously once daily 45-55 kg (99-121 lb) 5 mg subcutaneously once daily 35-45 kg (75-99 lb) 4 mg subcutaneously once daily <35 kg (<75 lb) 0.1 mg/kg subcutaneously once daily Treatment with SEROSTIM 0.1 mg/kg every other day was associated with fewer side effects, and resulted in a similar improvement in work output, as compared with SEROSTIM 0.1 mg/kg daily. Therefore, a starting dose of SEROSTIM 0.1 mg/kg every other day should be considered in patients at increased risk for adverse effects related to recombinant human growth hormone therapy (i.e., glucose intolerance). In general, dose reductions (i.e., reducing the total daily dose or the number of doses per week) should be considered for side effects potentially related to recombinant human growth hormone therapy. Most of the effect of SEROSTIM on work output and lean body mass was apparent after 12 weeks of treatment. The effect was maintained during an additional 12 weeks of therapy. There are no safety or efficacy data available from controlled studies in which patients were treated with SEROSTIM continuously for more than 48 weeks. There are no safety or efficacy data available from trials in which patients with HIV-associated wasting or cachexia were treated intermittently with SEROSTIM.

2.2 Preparation and

Administration Reconstitute SEROSTIM 5 mg vial or 6 mg vial with 0.5 mL to 1 mL of diluent, Sterile Water for Injection. Use the reconstituted solution immediately and use only one dose per vial for one patient. Discard any unused portion. Reconstitute SEROSTIM 4 mg vial with 0.5 mL to 1 mL of diluent, Bacteriostatic Water for Injection with 0.9% benzyl alcohol as a preservative. Do not use this diluent if the patient has a known hypersensitivity to benzyl alcohol or in pregnant or lactating women, instead reconstitute with Sterile Water for Injection and use only one dose per vial. Aim the stream of diluent against the glass vial wall to prevent foaming. Swirl the vial with a gentle rotary motion until contents are dissolved completely. Do not shake. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. SEROSTIM must not be injected if the solution is cloudy or contains particulate matter. Use the reconstituted solution only if it is clear or slightly opalescent. SEROSTIM 4 mg vial reconstituted with Bacteriostatic Water for Injection with 0.9% benzyl alcohol as preservative may be refrigerated at 2°C to 8°C (36°F to 46°F) for up to 14 days. Administer SEROSTIM using a standard sterile, disposable syringe and needle. Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation.