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Serostim ®
Serostim ® - (somatropin (rDNA origin) for injection)
EMD Serono, Incorporated offers human growth hormone Serostim ®, approved by the FDA in 1996, for the treatment of AIDS wasting syndrome in HIV-infected patients. AIDS-wasting is a metabolic disorder characterized by weight loss. Severe loss of weight and muscle, or lean body mass, common among AIDS patients, leads to muscle weakness, organ failure, and contributes to fatal outcomes. Results from one clinical trial of Serostim, a human growth hormone (HGH), showed that the drug increased the lean body mass of HGH-treated patients by an average of 1.6 kg (3.5 lbs.) compared with placebo-treated patients.
Serostim ® (somatropin (rDNA origin) for injection) is a human growth hormone produced by recombinant DNA technology. Serostim ® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone.
The most common adverse effects associated with the treatment included tissue swelling, as well as muscle and joint pain.
Serostim was granted an accelerated approval, which is a regulatory mechanism under which the agency may grant early approval for a drug that is used to treat patients with serious or life-threatening illnesses, and provides meaningful therapeutic benefit over existing therapies. Accelerated approvals are based on surrogate endpoints in clinical trials, rather than on clinical outcomes, such as strength or longer survival. Under the terms of this accelerated approval, the firm has agreed to conduct additional clinical studies to evaluate whether there is improvement in physical performance, and to substantiate previous finding of increased lean body mass.
Serostim ® has been shown in clinical studies to increase lean body mass and body weight, improve ones physical function and health-related quality of life outcomes.
Serostim ® works by interacting with specific cells to retain and build lean body mass, which includes muscle, organ tissue and body fluids. Serostim ® is administered by subcutaneous needle injection or by SeroJet ®. SeroJet ® is a needle-free delivery device that is patient friendly, and eliminates the risk of needle-stick injuries.
Serostim ® - somatropin (rDNA origin) for injection - made by EMD Serono, Inc. of Randolf, Massachusetts. For more information visit www.emdserono.com
May 16, 2002 - Serono Issues Notification of Counterfeit Serostim ®
Rockland, MA - May 16, 2002 - Serono, Inc. has recently become aware of a counterfeit lot of Serono's Serostim ® (somatropin (rDNA origin) for injection). The counterfeit material has been packaged to appear as drug product lot number S810-1A1. This is not a legitimate Serostim ® lot number. Serono has notified the appropriate regulatory and law enforcement authorities of this matter.
Preliminary information appears to indicate that the counterfeit material may have been distributed via the Internet. However, Serono is also alerting pharmacists to the counterfeit material and recommending that they examine Serostim ® prior to dispensing to ensure that the package does not bear lot number S810-1A1.
The counterfeit material was neither manufactured nor distributed by Serono. Therefore, it cannot be assumed that the counterfeit material is either safe or effective.
Serono continues to cooperate with regulatory and law enforcement authorities to identify and prosecute individuals involved in drug counterfeiting.
References:
U.S. Food and Drug Administration
FDA Talk Paper
August 1996
www.fda.gov/bbs/topics/ANSWERS/ANS00756a.html
U.S. Food and Drug Administration
NEWS RELEASE
May 2002
www.fda.gov/oc/po/firmrecalls/serono05_02.html
This summary does not include everything there is to know about the medicine mentioned above. Do not use this medicine without first talking to your doctor.
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