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Nutropin AQ® [somatropin (rDNA origin) injection] is produced by Genentech using recombinant DNA technology and has the same amino acid sequence as human growth hormone produced naturally in the human body. Recombinant growth hormone was cloned by Genentech scientists in 1979.

Nutropin AQ human growth hormone is the first ready-to-use liquid recombinant growth hormone formulation and is supplied as either 10mg of sterile liquid somatropin per vial or per pen cartridge.

Status

• In December 1995, Genentech received FDA approval for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation in conjunction with optimal management of chronic renal sufficiency and for the long-term treatment of growth failure due to lack of adequate endogenous growth hormone secretion for pediatric patients.
• In March 1997, Genentech received FDA approval for the long-term treatment of short stature associated with Turner syndrome in pediatric patients.
• In December 1997, Genentech received FDA approval for the replacement of endogenous growth hormone in patients with adult growth hormone deficiency who have a biochemical diagnosis of adult GH deficiency and either adult- or child- onset GH deficiency.
• In June 2005, Genentech received FDA approval for the long-term treatment of idiopathic 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 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.

Disease Education Growth hormone deficiency, GHD, is a pituitary disorder resulting in short stature and other physical ailments. GHD occurs when the production of growth hormone, secreted by the pituitary gland, is disrupted. Since growth hormone plays a critical role in stimulating body growth and development, and is involved in the production of muscle protein and in the breakdown of fats, a decrease in the hormone affects numerous body processes.

Turner syndrome affects approximately one in 2,500 female, live births. Turner syndrome is a chromosomal disorder that affects females exclusively and is characterized, in part, by short stature and ovarian dysfunction. It is caused by the absence of all or part of one of the X chromosomes.

Chronic renal insufficiency, CRI, affects about 3,000 children in the United States. It manifests through a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes. Kidney transplants can help a child start growing normally again, but most children do not make up the growth lost prior to transplantation.

Idiopathic short status (ISS), also called non-growth hormone-deficient short stature, is a condition caused by unknown reasons after a thorough diagnostic evaluation by an endocrine specialist. Children in this category are generally healthy; their ISS diagnosis is usually arrived at when other potential underlying causes are ruled out and the patient does not meet the strict criteria defined for growth hormone deficiency.

Safety Growth hormone (GH) should not be used for growth promotion in pediatric patients with closed epiphyses.

GH should not be used in patients with active proliferative or severe non-proliferative diabetic retinopathy.

In general, GH should not be used in patients with active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with growth hormone. GH therapy should be discontinued if there is evidence of recurring tumor activity. GH should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.

GH should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure.

GH is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of GH deficiency, Nutropin AQ and Nutropin are not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Patients being treated with Growth Hormone (GH) should be informed of the potential benefits and risks associated with Growth Hormone therapy.