Somatropin, recombinant

F. Role in therapy Micromedex notes that like somatropin (rDNA origin), somatrem is effective in the treatment of children with documented defidenq of growth hormone its effectiveness in constitutional short stature remains to be determined. Somatrem can be considered to be equal to somatropin in efficaq , but because of the increased incidence of immunogenic effects resulting in neutralizing antigrowth hormone antibodies seen with somatrem, it will likely take a secondary role to recombinant somatropin products in therapy. 

Patients treated with recombinant somatropin commonly develop antibodies against growth hormone the incidence is 22-88% (85). There were low titers of antigrowth hormone antibody, with no reduction in growth response, in 44% of children who used modified-release somatropin... 

Leukemia has been reported in a small number of pediatric patients treated with growth hormone, including growth hormone of pituitary origin and recombinant somatropin. The relationship, if any, between leukemia and growth hormone therapy is uncertain... 

On July 30, 2003, Sandoz submitted a 505(b)(2) application for the approval of its recombinant HGH product (recombinant somatropin) indicated for long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone and for long-term replacement therapy in adults with GHD of either childhood or adult onset. This application relied in part on data submitted in the Genotropin NDA. 

A dose of 1.5 mg is dispensed in a two-chamber cartridge. The front chamber contains recombinant somatropin (1.5 mg) (approximateiy 4.5 iU), giycine (27.6 mg), sodium dihydrogen phosphate anhydrous (0.3 mg), and disodium phosphate anhydrous (0.3 mg) the rear chamber contains 1.13-mL water for injection. The 5.8-mg dose system has in the rear chamber 0.3% m-cresoi (as a preservative) and mannitoi, 45 mg in 1.14-mL water for injection. Long acting contains 13.5 mg of somatropin,... 

Albertsson-Wikland K (1987). Clinical trial with authentic recombinant somatropin in Sweden and Finland. Acta Paedialrica Scandinavica (Suppl), 331 28-34. 

Hageman, M. J., Possert, P., Bauer, J. M. Prediction and characterization of the water sorption isotherm for bovine somatropin recombinant. Journal of Agricultural Food Chemistry, 40(2), p. 342-347, 1992. 

Somatropin is a protein having the structure (191 amino acid residues) of the major component of growth hormone produced by the human pituitary. Somatropin is produced by a method based on recombinant DNA technology. Recently the results of a collaborative study between 14 laboratories have been reported, in which a new CE method was compared with the existing test for isoform distribution by isoelectric focusing. The CE method was found to be superior to the method of isoelectric focusing. As a result CE is applied for identification... 

Recently, a CE method was introduced for impurity profiling of the human growth hormone somatropin produced by the recombinant DNA (rDNA) technology. ... 

A), 3.8 billion Amgen s white blood cell stimulant, Neupogen (filgrastim), 3.0 billion interferon pia (Avonex for multiple sclerosis), 2.2 billion human growth hormone (HGH), 1.8 billion recombinant hepatitis B vaccine ( 1.0 billion) somatropin (Humatrope and Neutropin), 0.9 billion and cerezyme/ceredase (alglucerase), 0.6 billion. 

The anabolic effects of somatropin are mediated by somatomedins or insulin-like growth factors. Somatropin is a synthetic polypeptide identical to the natural occurring growth hormone which stimulates longitudinal growth. Only preparations made with recombinant DNA technology are used nowadays. They can consist of 191 amino acids as growth hormone itself or 192 amino acids with one extra methionine. Somatropin is employed in the treatment... 

Somatropin [rDNA origin] for injection [FDA] Human growth hormone, recombinant [SY] hGH [SY]... 

Growth hormone is a 191-amino-acid peptide with two sulfhydryl bridges. Its structure closely resembles that of prolactin. In the past, medicinal GH was isolated from the pituitaries of human cadavers. However, this form of GH was found to be contaminated with prions that could cause Creutzfeldt-Jakob disease. For this reason, it is no longer used. Somatropin, the recombinant form of GH, has a 191-amino acid sequence that is identical with the predominant native form of human GH. 

Humatrope (somatropin) [E. coli-expressed recombinant polypeptide hormone] Eli Lilly Lyophilized 5 mg single-dose vials... 

This disease develops when an abnormal prion protein present in the cadaveric material induces a cascade of conformational changes in host protein. Creutzfeldt-Jakob disease in recipients of somatropin differs from the sporadic form, in that it usually presents with cerebellar signs rather than cognitive impairment, and also in the prominence of prion protein amyloid plaques in nervous tissue (18). In a review, 139 cases of Creutzfeldt-Jakob disease were identified worldwide in people treated with cadaveric somatropin before recombinant human growth hormone became available in the mid-1980s (19). The prevalence of this fatal neurodegenerative condition in recipients of somatropin ranges from 0.3% in the USA to 4.4% in France. Creutzfeldt-Jakob disease has been reported to start at 4-30 years after therapy with cadaveric somatropin (18), so that further cases are anticipated and continue to be reported (20). 

Cheng YH, Dyer M, Jabbal-Gill I, et al. Intranasal delivery of recombinant human growth hormone (somatropin) in sheep using chitosan-based powder formulations. Eur J Pharm Sci 2005 26 9-15. 

Humatrope (somatropin) Eli Lilly [E. coli-ex pressed recombinant polypeptide hormone]... 

USA somatropin peptide Humatrope Crescormon, Genotropin, Genotropin Miniquick, Umatrope, Genetonorm Recombinant human growth hormone expressed in E. coli Hormone... 

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