CinnaTropin®

Description

Somatropin is a recombinant human growth hormone that has a remarkable role in the growth of bones and muscles as well as metabolism. CinnaTropin^® is the brand name for somatropin produced by CinnaGen Company with proven comparable efficacy and safety to the reference product. Each pre-filled pen of CinnaTropin^® contains 5mg/1.5ml or 10mg/1.5ml somatropin.

Indications

CinnaTropin^® is indicated for pediatric and adult patients with growth failure due to inadequate secretion of endogenous growth hormone (GH). CinnaTropin^® is also indicated for pediatric patients with short stature associated with Turner syndrome or chronic renal insufficiency as well as children born small for gestational age (SGA) who failed to show catch-up growth by 4 years of age or later.

Important safety information

• CinnaTropin^® is contraindicated in patients with:

closed epiphyses (pediatrics); acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; active malignancy; active proliferative or severe nonproliferative diabetic retinopathy.

• Fluid retention: manifestations of fluid retention are generally transient and dose dependent. If symptoms of carpal tunnel syndrome do not resolve by decreasing the dose or frequency of somatropin, discontinue therapy.
• Slipped capital femoral epiphyses: Patients with endocrine disorders (including growth hormone deficiency and Turner syndrome) or patients undergoing rapid growth may develop slipped capital femoral epiphyses more frequently. Evaluate any child with new onset of a limp or with complaints of hip or knee pain.
• Glucose tolerance: Somatropin may decrease insulin sensitivity. Diabetic ketoacidosis and diabetic coma have been reported in some patients. Discontinuing somatropin may improve glucose tolerance in some patients. Adjustment of antidiabetic medications may be necessary.
• Intracranial hypertension: Intracranial hypertension with headache, nausea, papilledema, visual changes, and/or vomiting has been reported. symptoms usually occur within the first 8 weeks of therapy and signs and symptoms of intracranial hypertension may rapidly resolve after discontinuation or reduction of dose. Patients with Turner syndrome and chronic renal impairment may be at increased risk for intracranial hypertension.
• Neoplasm: Any preexisting malignancy should be inactive and treatment complete prior to initiating therapy.
• Scoliosis: Progression of scoliosis may occur in children experiencing rapid growth. Monitor for worsening of scoliosis.