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.
Renal/Hepatic Insufficiency: No data are available.
