Genotropin (somatropin) injection
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Growth failure in children who were born small for gestational age (SGA)
General Information
The FDA has approved Genotropin (somatropin [rDNA origin] for
injection) for the long-term treatment of growth failure in
children who were born small for gestational age (SGA). The drug is
indicated for children who do not achieve catch-up growth by age
two.
Small for gestational age (SGA) is a term used to describe an
infant who is smaller in size than expected based on the number of
weeks of pregnancy. Each year, as many as 12,000 children born SGA
do not "catch up" in terms of height by age two. Many of
these children remain significantly smaller than their peers and
may not reach normal height without medical intervention.
Since August 1995, Genotropin Lyophilized Powder has been
approved for the long-term treatment of growth failure in children
due to growth hormone deficiency (GHD). The drug is also currently
marketed as replacement therapy in adults with a confirmed
diagnosis of GHD of either childhood or adult onset. More recently,
Genotropin was approved for the treatment of pediatric patients
with Prader-Willi Syndrome, a genetically based developmental
disability.
Side Effects
Adverse events reported during clinical trials of Genotropin
include (but are not limited to) the following:
- Injection site reactions
- Headache
- Edema (fluid retention)
- Aggressiveness
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Hair loss
Mechanism of Action
Genotropin Lyophilized Powder contains somatropin [rDNA origin],
which is a polypeptide hormone of recombinant DNA origin.
In vitro, preclinical and clinical tests have demonstrated that
Genotropin Lyophilized Powder is therapeutically equivalent to
human growth hormone of pituitary origin and achieves similar
pharmacokinetic profiles in normal adults. In pediatric patients
who have growth hormone deficiency (GHD) or Prader-Willi syndrome
(PWS), treatment with Genotropin stimulates linear growth and
normalizes concentrations of IGF-I (Insulin-like Growth
Factor/Somatomedin-C). In adults with GHD, treatment with
Genotropin results in reduced fat mass, increased lean body mass,
metabolic alterations that include beneficial changes in lipid
metabolism, and normalization of IGF-I concentrations. (from
Genotropin Prescribing Information)
Additional Information
For additional information on Genotropin, please visit the
product web site at www.genotropin.com.
