      Document 0115
 DOCN  DRG0115
 UNIQUE IDENTIFIER        DRG-0132
 NAME OF SUBSTANCE        Somatrem [USAN 1996]
 REGISTRY NUMBER          82030-87-3
 STANDARD CHEMICAL NAME   Somatotropin (human), N-L-methionyl- [USAN
                          1996]
 SYNONYMS                 Protropin [USAN 1996]
 SYNONYMS                 rHGH [AmFAR Tx Dir 1995;7(4)]
 SYNONYMS                 Human growth hormone (recombinant) [AmFAR Tx
                          Dir 1995;7(4)]
 SYNONYMS                 Somatonorm [USP DI 1989]
 SYNONYMS                 N-L-Methionylgrowth hormone (human) [USAN
                          1996]
 SYNONYMS                 Methionyl human growth hormone [Merck Index
                          1989]
 SYNONYMS                 Somatotropin, methionyl (human) [MeSH]
 SYNONYMS                 Genotonorm [Merck Index 1989]
 SYNONYMS                 Maxomat [Merck Index 1989]
 SYNONYMS                 Umatrope [Merck Index 1989]
 PROTOCOL ID NUMBERS      NCI 91 C-234
 PROTOCOL ID NUMBERS      NCI 93 C-21
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Studies suggest that somatrem
                          plays an important role in the human immune
                          system, possibly through an interaction
                          between the pituitary and thymus glands.
                          Primarily, somatrem stimulates linear growth
                          by affecting cartilaginous growth areas of
                          long bones. Also stimulates the number and
                          size of muscle cells, influences the size of
                          organs, and increases red cell mass through
                          erythropoietin stimulation. Stimulates an
                          increase in somatomedin C levels. Also
                          influences metabolism of carbohydrates by
                          antagonizing the action of insulin and
                          possibly affecting glucose transport; of fats
                          by causing mobilization of fatty acids; of
                          minerals by the retention of phosphorus,
                          sodium, and potassium due to cell growth; and
                          of proteins by increasing nitrogen retention,
                          which results in increased cellular protein
                          synthesis. [AmFAR Tx Dir 1995;7(4)] [USP DI
                          1995] [PDR 1995]
 DISEASES STUDIED/TREATED Studied as a treatment for HIV-infected
                          wasting [AmFAR Tx Dir 1995;7(4)]
 DISEASES STUDIED/TREATED Being investigated for its role in the human
                          immune system [AmFAR Tx Dir 1995;7(4)]
 CLASSIFICATION CODE      Immunomodulator [AmFAR Tx Dir 1995;7(4)]
 OTHER MAJOR USES         Indicated for long-term treatment of children
                          with growth failure caused by inadequate
                          pituitary growth hormone secretion [PDR 1995]
 SUBSTANCE INTERACTIONS   May interact with glucocorticoids,
                          adrenocorticoids, corticotropins, anabolic
                          steroids, androgens, estrogens, and thyroid
                          hormones. May affect glucose tolerance tests
                          and thyroid function tests. [USP DI 1995]
 ADVERSE EFFECTS          Edema, salt and water retention, rare
                          instances of carpal-tunnel syndrome and rare
                          increases in brain pressure (benign
                          idiopathic intracranial hypertension) have
                          been reported as side effects of rHGH
                          treatment. Among GH-deficient children who
                          have received long-term rHGH therapy, the
                          development of anti-GH antibodies is the most
                          frequently observed side effect. These
                          antibodies are generally not neutralizing,
                          and no adverse effects have been observed to
                          result. Allergic reactions (skin rash,
                          itching), slipped capital femoral epiphysis.
                          [AmFAR Tx Dir 1993;6(4)] [USP DI 1995]
 CONTRAINDICATIONS        Contraindications include closed epiphyses,
                          active neoplasia (particularly intracranial
                          lesions), recurrent tumor growth, antitumor
                          therapy, untreated hypothyroidism. [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The genetically engineered
                          version of pituitary-derived human growth
                          hormone [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Contains the sequence of
                          191 amino acids constituting
                          pituitary-derived human growth hormone plus
                          one additional amino acid (methionine) at the
                          N-terminus of the molecule [PDR 1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: About 22000 [PDR 1995]
 CHEMICAL/PHYSICAL DATA   SOLUBILITY: Water soluble [PDR 1995]
 CHEMICAL/PHYSICAL DATA   STABILITY: Should be used within 14 days
                          following reconstitution [PDR 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White lyophilized
                          powder [PDR 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 5 or 10 mg (approximately 13 or
                          26 IU) in vials. [PDR 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular or
                          subcutaneous. [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store at 2-8 C (36-46 F). [PDR 1995]
 MANUFACTURERS            Genentech, Incorporated
 REFERENCES               Schambelan M, Mulligan K, Grunfeld C, Darr E,
                          Lamarca A, Breitmeyer J. Recombinant human
                          growth hormone (rhGH) increases lean body
                          mass (LBM) and improves functional
                          performance in patients with HIV-associated
                          wasting. Natl Conf Hum Retroviruses Relat
                          Infect (2nd). 1995 Jan 29-Feb 2;:170.
 REFERENCES               Hirschfeld S, Tudor-Williams G, Stocker V,
                          Jacobsen F, Laue L, Cutler GB, Pizzo PA.
                          Effects of recombinant human growth hormone
                          and recombinant insulin-like growth factor-I
                          administration in children with human
                          immunodeficiency virus infection and growth
                          failure. Natl Conf Hum Retroviruses Relat
                          Infect (2nd). 1995 Jan 29-Feb 2:;149.
 REFERENCES               Koster F, Nightingale S, Gesundheit N, Waters
                          D, Bukar J, Qualls C, Danska J, Watson D,
                          Jackson L, Hardy K, et al. A randomized,
                          double blind placebo-controlled phase II
                          trial of growth hormone and insulin-like
                          growth factor I for AIDS wasting. Program
                          Abstr Intersci Conf Antimicrob Agents
                          Chemother. 1994 Oct 4-7;:56.
 REFERENCES               Bukar JG, Jackson L, Muro J, Jenks BH, Bakst
                          R, Brodsky M, Gesundheit N. Effect of a
                          combination of growth hormone (rhGH) and
                          insulin-like growth factor-I (rhIGF-I) on the
                          appetite of HIV-1+ patients (PTS) with weight
                          (WT) loss. Int Conf AIDs. 1994 Aug
                          7-12;10(2):222 (abstract no. PB0903).
 REFERENCES               Lieberman SA, Butterfield GE, Harrison D,
                          Hoffman AR. Anabolic effects of recombinant
                          insulin-like growth factor-I in cachectic
                          patients with the acquired immunodeficiency
                          syndrome. J Clin Endocrinol Metab. 1994
                          Feb;78(2):404-10.
 REFERENCES               Nguyen BY, Clerici M, Bauza S, Bailey J,
                          Longo D, Murphy W, Shearer G, Gesundheit N,
                          Broder S, Yarchoan R. A pilot study of
                          recombinant human insulin-like growth hormone
                          (rhIGF-1) and recombinant human growth
                          hormone (rhGH) in patients with HIV-1
                          infections. Natl Conf Hum Retroviruses Relat
                          Infect (1st). 1993 Dec 12-16;:74.
 REFERENCES               Mulligan K, Grunfeld C, Hellerstein MK, Neese
                          RA, Schambelan M. Anabolic effects of
                          recombinant human growth hormone in patients
                          with wasting associated with human
                          immunodeficiency virus infection. J Clin
                          Endocrinol Metab. 1993 Oct;77(4):956-62.
 REFERENCES               Krentz AJ, Koster FT, Crist DM, Finn K,
                          Johnson LZ, Boyle PJ, Schade DS.
                          Anthropometric, metabolic, and immunological
                          effects of recombinant human growth hormone
                          in AIDS and AIDS-related complex. J Acquir
                          Immune Defic Syndr. 1993 Mar;6(3):245-51.
 REFERENCES               Bornstein P, Mercado M, Phair J, Murphy R.
                          Human Growth hormone (HGH) and insulin-like
                          growth factor-1 (IGF-1) in HIV-infected
                          patients. Int Conf AIDS 1993 Jun
                          6-11;9(1):293 (abstract no. PO-B02-0950).
 REFERENCES               Krentz AJ, Koster FT, Crist DM, Finn K, et
                          al. Antropometric, metabolic, and
                          immunological effects of recombinant human
                          growth hormone in AIDS and AIDS-related
                          complex. J Acquir Immune Defic Syndr. 1993
                          Mar;6(3):245-51.
 ENTRY MONTH              9112
 LAST REVISION DATE       960307
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
