Today is Friday, May 18, 2012
| SEROSTIM® HGH: Human Growth Hormone Product
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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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