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CLINICAL PHARMACOLOGY

Sermorelin acetate for injection increases plasma growth hormone (GH) concentration by stimulating the pituitary gland to release GH. Sermorelin is similar to the native hormone (GRF [1-44]-NH 2 ) in its ability to stimulate GH secretion in humans. Pharmacokinetics

Absorption

In subcutaneous administration of 2 mg sermorelin to 12 normal volunteers, peak concentrations of sermorelin were reached in 5-20 minutes. The mean absolute bioavailability after SC administration is about 6%.

Distribution

After intravenous administration of 0.25-1.0 mg Sermorelin® to 12 normal volunteers, the mean volume of distribution ranged between 23.7-25.8 liters.

Metabolism

No metabolism studies have been performed in humans.

Elimination

Sermorelin is rapidly cleared from the circulation, with clearance values in adults ranging between 2.4-2.8 L/min. The halflife of Sermorelin is short, 11-12 minutes after either intravenous or subcutaneous administration.

Special Populations

Gender/Age: No gender data are available in pediatric patients. In normal adults, the clearance of sermorelin in men and women is similar. No age data are available.