Pharmaceutical Name

Trade (marketing or proprietary) name: Nutropin AQ

Generic (nonproprietary or active ingredient) name: somatropin (rDNA origin) injection

Indication and Usage

Reason the product has been approved for sale on the market.

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.
• Adult Patients: Treatment of adults with either childhood-onset or adult-onset GHD.

Manufacturer Insert

Ingredients

Human growth hormone (hGH) produced by recombinant DNA technology, 17.4 mg sodium chloride, 5 mg phenol, 4 mg polysorbate 20, and 10 mM sodium citrate.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Progression of scoliosis in patients who experience rapid growth. Increased risk of ear/hearing disorders as well as hypertension, aortic aneurysm or dissection, and stroke. When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. Pancreatitis, Significant diabetic retinopathy, and Unmasking of latent central hypothyroidism. Intracranial Hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting. As with any protein, local or systemic allergic reactions may occur. Parents/patients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur. Sudden death in pediatric patients with Prader-Willi syndrome (PWS) with risk factors including severe obesity, history of upper airway obstruction or sleep apnea and unidentified respiratory infection. Intracranial tumors, in particular meningiomas, in teenagers/young adults treated with radiation to the head as children for a first neoplasm and somatropin. Glucose intolerance including impaired glucose tolerance/impaired fasting glucose as well as overt diabetes mellitus. Slipped capital femoral epiphysis in pediatric patients. Immunogenicity (ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human). Fluid retention manifested by edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias. Lipoatrophy (localized loss of fat tissue). Leukemia has been reported in a small number of GHD children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin. Gynecomastia (abnormal non-cancerous enlargement of one or both breasts in males due to the growth of breast tissue as a result of a hormone imbalance between estrogens and androgens).

Analytical Deep Dive

What is informed consent?