SOMATROPIN

Other

Brand names: Norditropin

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis. Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.

Indications

short stature associated with Noonan syndrome

short stature associated with Turner syndrome

short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years

Idiopathic Short Stature (ISS)

• short stature associated with Noonan syndrome

• short stature associated with Turner syndrome

Contraindications

• 4 CONTRAINDICATIONS NORDITROPIN is contraindicated in patients with: • Acute critical illness after open heart surgery
• abdominal surgery or multiple accidental trauma
• have a history of upper airway obstruction or sleep apnea
• have history of severe upper airway obstruction

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Increased Risk of Neoplasms : Second neoplasms have occurred in childhood cancer survivors
Monitor glucose levels periodically in all patients receiving NORDITROPIN, especially in patients with existing diabetes mellitus or at risk for development
5 ) • Severe Hypersensitivity : Serious hypersensitivity reactions may occur
2 Sudden Death in Pediatric Patients with Prader-Willi Syndrome There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection

Known Side Effects

1 documented side effects by frequency

Injection Site Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous