Humatrope (somatropin [rDNA origin] for injection)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 1996

Specific Treatments:

Somatropin Deficiency Syndrome

Therapeutic Areas

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General Information

Humatrope has been approved as a treatment for Somatropin Deficiency Syndrome, frequently associated with hypopituitarism. Humatrope is a synthetic human growth hormone (gGH) that has been used since 1987 as a replacement therapy for children who do not produce enough or any of their own hGH.

Clinical Results

In clinical trials, Humatrope therapy improved some of the symptoms that SDS subjects experienced. Humatrope therapy resulted in an increase in lean muscle mass, a decrease in body fat, an increase in exercise capacity, and normalization of low HDL cholesterol levels in SDS subjects.

Side Effects

Early in clinical trials, SDS subjects taking Humatrope experienced edema and peripheral edema more frequently than subjects receiving placebo. Other signs and symptoms reported during therapy include edema, joint pains or disorders, back pain, headaches, muscle aches, hypertension, and rhinitis. Many of the signs and symptoms reported during therapy; however, resolved either spontaneously or in response to dosage adjustments.

Additional Information

SDS adults may have hypopituitarism as a result of primary tumors, trauma, or other pituitary disorders, or they may have been treated for growth hormone deficiency as children. Adults with SDS suffer from metabolic disorders that affect their physical mobility, socialization and energy levels, as well as their life expectancy. Some epidemiologic studies have suggested that adults with SDS are at greater risk of cardiovascular disease than adults without the disorder.