SOMATROPIN (Nutropin AQ NuSpin 10) Nursing Considerations

What is the generic name?

SOMATROPIN

What is the Trade Name for SOMATROPIN?

Nutropin AQ NuSpin 10

What are the Indications for SOMATROPIN?

• 1 INDICATIONS AND USAGE Nutropin AQ is a recombinant human growth hormone indicated for: Pediatric Patients : Treatment of children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), and chronic kidney disease (CKD) up to the time of renal transplantation ( 1.1 ). Adult Patients: Treatment of adults with either childhood-onset or adult-onset GHD ( 1.2 ). 1.1 Pediatric Patients Growth Hormone Deficiency (GHD) – Nutropin AQ ¬Æ is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH). Growth Failure Secondary to Chronic Kidney Disease (CKD) – Nutropin AQ is indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of CKD. Idiopathic Short Stature (ISS) – Nutropin AQ is indicated for the treatment of ISS, also called non-GHD short stature, defined by height SDS ‚⧠‚Äì2.25, 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. Short Stature Associated with Turner Syndrome (TS) – Nutropin AQ is indicated for the treatment of short stature associated with TS. 1.2 Adult Patients Nutropin AQ is indicated for the replacement of endogenous GH in adults with GHD who meet either of the following two criteria: Adult Onset : Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset : Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients who were treated with somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GHD.

References: https://open.fda.gov/