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Nutropin ®

Nutropin ® - (somatropin (rDNA origin) for injection)

Nutropin ® is a human growth hormone (hGH) produced by recombinant DNA technology. Nutropin has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of pituitary-derived human growth hormone. The protein is synthesized by a specific laboratory strain of E. coli as a precursor consisting of the rhGH molecule preceded by the secretion signal from an E. coli protein. This precursor is directed to the plasma membrane of the cell. The signal sequence is removed and the native protein is secreted into the periplasm so that the protein is folded appropriately as it is synthesized.

Nutropin ® is a highly purified preparation. Biological potency is determined using a cell proliferation bioassay. Nutropin is a sterile, white, lyophilized powder intended for subcutaneous administration after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). The reconstituted product is nearly isotonic at a concentration of 5 mg/mL growth hormone (GH) and has a pH of approximately 7.4.

Bacteriostatic Water for Injection, USP is sterile water containing 0.9 percent benzyl alcohol per mL as an antimicrobial preservative packaged in a multidose vial. The diluent pH is 4.5-7.0.

Indications and Usage
Nutropin ® somatropin (rDNA origin) for injection indicated for:

• Pediatric Patients (Children):
  • Long-term treatment in children with growth failure due to lack of adequate endogenous growth hormone (GH) secretion
  • Treatment of growth failure in children associated with chronic renal insufficiency until time of kidney transplant
  • Long-term treatment of short stature in children associated with Turner Syndrome
  • Long-term treatment of idiopathic short stature, also called non-growth hormone-deficient short stature, defined by height SDS =-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in children whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means
• Adult Patients:
  • Replacement of endogenous growth hormone (GH) in adults with growth hormone (GH) deficiency who meet two criteria:
    • 1 - Biochemical diagnosis of adult growth hormone (GH) deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak GH=5 µg/L)
    • 2 - Adult-onset patients who have adult growth hormone (GH) deficiency either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma or childhood-onset patients who were growth hormone (GH) deficient during childhood, confirmed as an adult before replacement therapy with Nutropin is started

Nutropin ® - somatropin (rDNA origin) for injection - made by Genentech, Inc., South San Francisco, California. For more information call 800-879-4747 or visit www.nutropin.com

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