Humatrope Description<\/h1>\n

Brand Name: HUMATROPE<\/p>\n

Generic Name: Somatropin<\/p>\n

Humatrope\u00ae<\/span><\/a>\u00a0<\/span>(Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of recombinant DNA origin. Humatrope has 191\u00a0amino acid residues and a molecular weight of about 22,125\u00a0daltons. The amino<\/a> acid sequence of the product is identical to that of human growth hormone of pituitary origin. Humatrope is synthesized in a strain of Escherichia\u00a0coli that has been modified by the addition of the gene for human growth hormone.<\/p>\n

Humatrope is a sterile, white, lyophilized powder intended for subcutaneous or intramuscular administration after reconstitution. Humatrope is a highly purified preparation. Phosphoric acid and\/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately\u00a07.5. This product is oxygen sensitive.<\/p>\n

VIAL\u00a0\u2014\u00a0Each vial of Humatrope contains 5\u00a0mg somatropin (15\u00a0IU or 225\u00a0nanomoles); 25\u00a0mg mannitol; 5\u00a0mg glycine; and 1.13\u00a0mg dibasic sodium phosphate. Each vial is supplied in a combination package with an accompanying 5\u2013mL vial of diluting solution. The diluent contains Water for Injection with 0.3%\u00a0Metacresol as a preservative and 1.7%\u00a0glycerin.<\/p>\n

Humatrope Somatrem and somatropin are man-made versions of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in children who have certain conditions that cause failure to grow normally. These conditions include growth hormone deficiency (inability to produce enough growth hormone), kidney disease, Prader-Willi Syndrome (PWS), and Turner’s syndrome. Growth hormone is also used in adults to treat growth failure and to treat weight loss caused by acquired immunodeficiency syndrome (AIDS).<\/p>\n

Pediatric Patients\u00a0\u2014\u00a0Humatrope is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.<\/p>\n

Humatrope is indicated for the treatment of short stature associated with Turner\u00a0syndrome in patients whose epiphyses are not closed.<\/p>\n

Humatrope is indicated for the treatment of idiopathic short stature, also called non\u2013growth hormone\u2013deficient short stature, defined by height SDS\u00a0\u2264\u20132.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients 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.<\/p>\n

Humatrope is indicated for the treatment of short stature or growth failure in children with SHOX (short stature homeobox-containing gene) deficiency whose epiphyses are not closed.<\/p>\n

Adult Patients\u00a0\u2014\u00a0Humatrope [somatropin (rDNA origin) for injection] is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two\u00a0criteria:<\/p>\n

1. Adult Onset: Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or<\/p>\n

2. Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.<\/p>\n

In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital\/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.<\/p>\n

Patients with a known sensitivity to either Metacresol or glycerin should not receive Humatrope reconstituted with the supplied Diluent for Humatrope.<\/p>\n

Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.<\/p>\n

If sensitivity to the diluent should occur, the vials may be reconstituted with Bacteriostatic Water for Injection,\u00a0USP or, Sterile Water for Injection,\u00a0USP. When Humatrope is used with Bacteriostatic Water (Benzyl Alcohol preserved), the solution should be kept refrigerated at 2\u00b0\u00a0to\u00a08\u00b0C (36\u00b0\u00a0to\u00a046\u00b0F) and used within 14\u00a0days. Benzyl alcohol as a preservative in Bacteriostatic Water for Injection,\u00a0USP has been associated with toxicity in newborns. When administering Humatrope to newborns, use the Humatrope diluent provided or if the patient is sensitive to the diluent, use Sterile Water for Injection,\u00a0USP. When Humatrope is reconstituted with Sterile Water for Injection,\u00a0USP in this manner, use only one\u00a0dose per Humatrope vial and discard the unused portion. If the solution is not used immediately, it must be refrigerated [2\u00b0\u00a0to\u00a08\u00b0C (36\u00b0\u00a0to\u00a046\u00b0F)] and used within 24\u00a0hours.<\/p>\n