HIV-Associated Wasting or Cachexia

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 (see PRECAUTIONS).

HIV-Associated Wasting or Cachexia

The usual starting dose of Serostim® [somatropin (rDNA origin) for injection] is 0.1 mg/kg subcutaneously (SC) daily (up to 6 mg). It should be administered SC daily at bedtime according to the following dosage recommendations:

Serostim® 8.8 mg and Serostim® 4 mg with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol), multi-use vials, should be administered as per the above weight-based dosing table. Serostim® 5 or 6 mg with Sterile Water for Injection, USP, single use vials, should be administered to patients requiring 5 or 6 mg daily, respectively, as per the above weight-based dosing table.

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, which are unresponsive to symptom-directed treatment.

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 were treated intermittently with Serostim®.

Injection sites should be rotated to avoid local irritation.

Safety and effectiveness in pediatric patients with HIV have not been established.

Each vial of Serostim® 5 mg or 6 mg is reconstituted with 0.5 to 1 mL Sterile Water for Injection, USP. Each vial of Serostim® 8.8 mg is reconstituted in 1 to 2 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved) and each vial of Serostim® 4 mg is reconstituted in 0.5 to 1 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved). Approximately 10% mechanical loss can be associated with reconstitution and administration from multi-dose vials. For patients sensitive to this diluent, see WARNINGS.

To reconstitute Serostim®, inject the diluent into the vial of Serostim® aiming the liquid against the glass vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved completely. The Serostim® solution should be clear immediately after reconstitution. DO NOT INJECT Serostim® if the reconstituted product is cloudy immediately after reconstitution or after refrigeration (2-8oC/36-46oF) for up to 14 days. Occasionally, after refrigeration, small colorless particles may be present in the Serostim® solution. This is not unusual for proteins like Serostim®.

Stability And Storage

Before reconstitution: Vials of Serostim® and diluent should be stored at room temperature, (15°-30°C/59°-86°F). Expiration dates are stated on product labels.

After Reconstitution with Sterile Water for Injection, USP: The reconstituted solution should be used immediately and any unused portion should be discarded.

After Reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol): The reconstituted solution should be stored under refrigeration (2-8oC/36-46oF) for up to 14 days.

Avoid freezing reconstituted vials of Serostim®.

Serostim® can be administered using (1) a standard sterile, disposable syringe and needle, (2) a compatible Serostim® needle-free injection device or (3) a compatible Serostim® needle injection device. For proper use, refer to the Instructions for Use provided with the administration device.

Serostim® [somatropin (rDNA origin) for injection] is available in the following forms:

Serostim® vials containing 5 mg (approximately 15 IU) somatropin (mammalian-cell) with Sterile Water for Injection, USP. Package of 7 vials......................NDC 44087-0005-7

Serostim® vials containing 6 mg (approximately 18 IU) somatropin (mammalian-cell) with Sterile Water for Injection, USP. Package of 7 vials......................NDC 44087-0006-7

Serostim® vials containing 4 mg (approximately 12 IU) somatropin (mammalian-cell) with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). Package of 7 vials...................... NDC 44087-0004-7

Serostim® vial containing 8.8 mg (approximately 26.4 IU) somatropin (mammalian-cell) with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). Package of 1 vial........................NDC 44087-0088-1

Serostim® vials containing 8.8 mg (approximately 26.4 IU) somatropin (mammalian-cell) with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). Package of 4 vials....................... NDC 44087-0088-4

Manufactured for: EMD Serono, Inc., Rockland, MA 02370. July 2007. FDA Rev date: 8/27/2007

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