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The Pharmacokinetic and Pharmacodynamic Characteristics of a Long-Acting Growth Hormone (GH) Preparation (Nutropin Depot) in GH-Deficient Adults

Oregon Health Sciences University (D.M.C.), Portland, Oregon 97201; Massachusetts General Hospital (B.M.K.B.), Boston, Massachusetts 02114; University of Virginia (M.L.V.), Charlottesville, Virginia 22901; Veterans Affairs Palo Alto Health Care System and Stanford University School of Medicine (A.R.H.), Palo Alto, California 94304; Emory University (L.S.P.), Atlanta, Georgia 30322; Alkermes, Inc. (K.M.F., D.P.B., A.I.), Cambridge, Massachusetts 02139; and Genentech, Inc. (S.L.B., K.M.A., L.N.D., J.D.R., P.J.F.), South San Francisco, California 94080

Address all correspondence and requests for reprints to: David M. Cook, M.D., Department of Medicine/Division of Endocrinology, Oregon Health Sciences University, 3181 SW Sam Jackson Park Road, M/S L-607, Portland, Oregon 97201. E-mail: cookd{at}ohsu.edu.

Abstract

A pharmacokinetic-pharmacodynamic study of a long-acting GH [Nutropin Depot; somatropin (rDNA origin) for injectable suspension] was performed in 25 patients with adult GH deficiency. Single doses of 0.25 mg/kg and 0.5 mg/kg, based on ideal body weight, were administered sc. After either dose, serum GH concentrations rose rapidly in both sexes. In men, the lower dose maintained serum IGF-I levels within 1 SD of the mean for age and sex for 14–17 d; the higher dose raised IGF-I levels 2 SD above the mean. In most women, all of whom were receiving oral estrogen, the lower dose did not normalize IGF-I levels; the higher dose maintained IGF-I near the mean for approximately 14 d. Increases in IGF binding protein-3 and acid-labile subunit levels were observed in both sexes; however, a sex-related difference was not obvious. Fasting glucose and insulin concentrations were transiently elevated in men receiving the higher dose. Patients tolerated the injections well. We concluded that a single injection of Nutropin Depot at these doses in patients with adult GH deficiency increased serum IGF-I to within normal limits for 14–17 d. Estrogen-treated women required approximately twice the dose needed in men to produce comparable IGF-I concentrations.

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