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.

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.

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:

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 wasting or cachexia were treated intermittently with Serostim®.

Preparation and Administration

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® 4 mg is reconstituted in 0.5 to 1 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved). For patients sensitive to Benzyl Alcohol, Serostim® may be reconstituted with Sterile Water for Injection, USP. [See Pediatric Use]

When Serostim® is reconstituted with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded

When Serostim® is reconstituted with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved) the reconstituted solution may be refrigerated (2-8^oC/36-46^oF) for up to 14 days.

Approximately 10% mechanical loss can be associated with reconstitution and administration from multi-dose vials.

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. 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 it only if it is clear and colorless.

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. Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation.

Dosage Forms And Strengths

Single-use administration (to be reconstituted with Sterile Water for Injection):

• Serostim® 5 mg per vial
• Serostim® 6 mg per vial

Multi-use administration (to be reconstituted with Bacteriostatic Water for Injection):

• Serostim® 4 mg per vial

Serostim® is available in the following forms:

Serostim® single-use vials containing 5 mg with Sterile Water for Injection, USP. Package of 7 vials. NDC 44087-0005-7

Serostim® single-use vials containing 6 mg with Sterile Water for Injection, USP. Package of 7 vials. NDC 44087-0006-7

Serostim® multiple-use vials containing 4 mg with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). Package of 7 vials. NDC 44087-0004-7

Storage and Handling

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.

Single-use vials: After reconstitution with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded.

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

Avoid freezing reconstituted vials of Serostim®.

Manufactured for: EMD Serono, Inc., Rockland, MA 02370. Revised: April 2012

Last reviewed on RxList: 4/16/2012
This monograph has been modified to include the generic and brand name in many instances.