Serono, Inc., has announced the FDA’s final approval of somatropin (recombi-nant DNA origin) for injection (Sero-stim®) for the treatment of patients with human immunodeficiency virus (HIV) infection who are experiencing body wasting or cachexia (decreased intake of food and loss of appetite). The drug has helped patients increase their lean body mass and body weight and improve their physical endurance.
Serostim® received accelerated approval in 1996, a special regulatory status for drugs that are used to treat patients with serious or life-threatening illnesses and that provide therapeutic benefits over other existing treatments.
The recommended dose is 0.1 mg/kg daily or 6 mg/day for patients weighing more than 55 kg. The starting dose in patients thought to be at risk of certain adverse effects, such as glucose intolerance, is considered to be 0.1 mg/kg every other day.
Serostim® is generally well tolerated. The most common adverse events are mild-to-moderate muscle and joint pain and swelling or edema, which are dose-related and often subside with continued treatment or dose reduction.
New-onset impaired glucose intolerance, new-onset type-2 diabetes mellitus, and exacerbation of pre-existing diabetes mellitus have been reported; diabetic ketoacidosis and diabetic coma have developed. In some patients, initiation or adjustment of antidiabetic treatment was required. Patients with a history of hyperglycemia or other risk factors for glucose intolerance should be monitored closely during treatment with Sero-stim®. Transient increases in glucose levels occur early in treatment, and monitoring is required.
Growth hormone is contraindicated in patients in intensive- care units (because of surgical complications, trauma, or acute respiratory failure), patients with active neoplasia, and patients with a known hypersensitivity to the hormone.
Serostim® must be used in conjunction with antiretroviral therapy.