Drug Guide

Generic Name

Somatropin Recombinant

Brand Names Zorbtive

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/A

Drug-Herb Interactions

N/A

Nursing 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.

This guide is for educational purposes only and is not intended for clinical use.