Drug Guide
Somatropin Recombinant
Classification
Therapeutic: Biologic Therapy for Growth Failure and Short Bowel Syndrome
Pharmacological: Growth Hormone (GH) Analog)
FDA Approved Indications
- Short bowel syndrome in adults receiving specialized nutrition
- Growth failure due to inadequate secretion of endogenous growth hormone in pediatric patients
Mechanism of Action
Somatropin is a recombinant DNA-derived human growth hormone that stimulates growth, cell reproduction, and cell regeneration by binding to growth hormone receptors, thereby increasing insulin-like growth factor-1 (IGF-1) production, which mediates many of the growth-promoting effects.
Dosage and Administration
Adult: Dose varies based on indication; for short bowel syndrome, typically 0.1 mg/kg subcutaneously once daily, titrated based on response.
Pediatric: Dosing depends on weight and indication; often 0.025 to 0.05 mg/kg/day divided into daily subcutaneous injections.
Geriatric: No specific adjustments needed; use with caution due to increased risk of adverse effects.
Renal Impairment: Use with caution; dose adjustments may be necessary based on clinical response.
Hepatic Impairment: Use with caution; close monitoring advised.
Pharmacokinetics
Absorption: Subcutaneous administration; absorption is slow and variable.
Distribution: Distributed widely in bodily tissues.
Metabolism: Metabolized via proteolysis into amino acids.
Excretion: Excreted primarily as amino acids after metabolism.
Half Life: Approximately 3.5 hours.
Contraindications
- Active malignancy
- Hypersensitivity to somatropin or excipients
Precautions
- Diabetic patients or those with glucose intolerance, because GH can induce insulin resistance.
- Patients with intracranial hypertension or related symptoms.
Adverse Reactions - Common
- Injection site reactions (Common)
- Edema (Common)
- Arthralgia or myalgia (Common)
Adverse Reactions - Serious
- Intracranial hypertension (Rare)
- Glucose intolerance or diabetes mellitus (Uncommon)
- Anaphylaxis (Rare)
Drug-Drug Interactions
- Glucocorticoids (may diminish the effect of somatropin)
- Hormonal therapies
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor growth response, blood glucose levels, and thyroid function.
Diagnoses:
- Risk for impaired glucose tolerance
Implementation: Administer subcutaneously as prescribed, preferably at the same time daily.
Evaluation: Assess for improvement in growth parameters in pediatric patients and nutritional status in adults.
Patient/Family Teaching
- Instruct on proper injection technique.
- Report any severe headache, visual changes, or signs of allergic reaction.
- Regular follow-up appointments for monitoring response.
Special Considerations
Black Box Warnings:
- Potential for neoplastic growth; use with caution in patients with active malignancy.
Genetic Factors: Growth response may vary based on underlying genetic conditions.
Lab Test Interference: May alter glucose and thyroid function tests.
Overdose Management
Signs/Symptoms: Signs of hypoglycemia or hyperglycemia, fluid retention, or possible tumor growth.
Treatment: Discontinue drug; supportive care; address symptoms accordingly.
Storage and Handling
Storage: Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F).
Stability: Stable until the expiration date on the vial when stored properly. Once reconstituted, use immediately or store in a refrigerator for no more than 24 hours.