Full Prescribing Information

Nutropin® [somatropin (rDNA origin) for 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 is indicated for the treatment of growth hormone deficiency in children and adults, growth failure associated with chronic renal insufficiency prior to kidney transplantation, short stature associated with Turner syndrome, and long-term treatment of idiopathic short stature.

Status

• In November 1993, Genentech received U.S. Food and Drug Administration (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 insufficiency.
• In March 1994, Genentech received FDA approval for the long-term treatment of growth failure due to lack of adequate endogenous growth hormone secretion for pediatric patients. Nutropin becomes the first growth hormone product to receive FDA approval for two indications.
• In December 1996, Genentech received FDA approval for the long-term treatment of short stature associated with Turner syndrome.
• 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.

Important Safety Information

• Nutropin is not for children and teenagers whose bones have finished growing.
• Nutropin is not for patients who have certain types of eye disease caused by diabetes.
• Nutropin is not for patients who have active cancer or any brain tumors.
• Nutropin is not for patients who are critically ill after open heart surgery or abdominal (stomach) surgery, are severely hurt, or have severe breathing problems.
• Nutropin is not for children and teenagers who have Prader-Willi syndrome and are very overweight or have trouble breathing.
• Patients who are about to start taking Nutropin, or are already taking it, must tell their doctor about all of the medications they are taking, including supplements; if they have or develop a brain tumor; if they are given any new medication — especially cortisone, hydrocortisone, prednisone, prednisolone, dexamethasone, triamcinolone, or betamethasone; if they are pregnant or if they become pregnant; about any other condition or illness they have or develop.
• As with any injection, patients may experience discomfort, soreness, or redness where Nutropin is injected.
• Patients should contact their doctor immediately if they experience ongoing injection site discomfort; curvature of the spine (scoliosis); joint pain; puffy hands and/or feet (caused by fluid retention); changes in vision, a bad headache, or nausea with or without vomiting; hip or knee pain; a need to limp when they walk; pain in wrist (carpel tunnel); allergic reactions.
• Patients must inject Nutropin at a different recommended place on their body each time. The doctor or nurse should supervise the first injection and provide training and instruction.

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.