Serostim — Medica
Human Immunodeficiency Virus Infection with Wasting or Cachexia in an Adult
Initial criteria
- age ≥ 18 years
- Patient meets at least ONE of the following: documented unintentional weight loss of ≥ 10% from baseline OR weight < 90% of the lower limit of ideal body weight OR body mass index (BMI) ≤ 20 kg/m2
- Patient has wasting or cachexia due to malabsorption, poor diet, opportunistic infection, or depression AND other causes have been addressed prior to starting somatropin
- Patient has been on antiretroviral therapy or highly active antiretroviral therapy for ≥ 30 days prior to beginning Serostim and will continue antiretroviral therapy throughout Serostim treatment
- Serostim is not being used solely for treatment of alterations in body fat distribution such as increased abdominal girth, lipodystrophy, excess abdominal fat, or dorsocervical fat pad
- Patient has tried one appetite stimulant or other anabolic agent (e.g., megestrol acetate, dronabinol, oxandrolone) OR such agents are contraindicated
Approval duration
6 months