Physicians Prescription Injectable Growth Hormone Therapy, HRT > SEROSTIM®:
Serono offers Serostim®
[somatropin (rDNA origin) for injection], the only growth hormone
approved by the U.S. Food and Drug Administration for the treatment
of HIV-associated wasting or cachexia. Through SeroCare®, Serono
offers comprehensive support to healthcare providers and patients
including education and appropriate access to care and treatment.
Serostim® (recombinant
human growth hormone) works by interacting with specific cells to
restore and build lean body mass (LBM). LBM includes muscle, organ
tissue (excluding fat), and body fluids.
It is the only growth
hormone approved by the U.S. Food and Drug Administration for the
treatment of AIDS wasting or cachexia. Serostim® is mammalian
cell-derived and produced using recombinant technology.
Clinical trials show
that Serostim® has been effective in the treatment of AIDS wasting
or cachexia. FDA approval is based on clinical studies up to 12
weeks in duration that analyzed body weight and lean body mass as
an intermediate measure of Serostim®'s efficacy for AIDS wasting.
A further study is underway to evaluate the full impact of Serostim®
on patients' physical endurance and quality of life.
Serostim® must be
used in conjunction with antiretroviral therapy. 76% of patients
evaluated at week 2 of treatment had weight gain. Patients who continue
to lose weight at week 2 should be reevaluated for concurrent opportunistic
infections or other clinical events. The recommended duration of
treatment is 12 weeks. No significant additional treatment benefit
was observed in patients receiving therapy beyond 12 weeks. There
are no data available from studies for patients who start, stop
and restart treatment.
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