Drug Guide
Lonapegsomatropin-tcgd
Classification
Therapeutic: Growth hormone deficiency
Pharmacological: Recombinant human growth hormone
FDA Approved Indications
- Treatment of pediatric growth failure due to growth hormone deficiency
Mechanism of Action
Lonapegsomatropin is a long-acting recombinant human growth hormone that stimulates growth and cell reproduction by binding to growth hormone receptors, leading to increased production of insulin-like growth factor-1 (IGF-1).
Dosage and Administration
Adult: Typically not indicated; primarily used in pediatric patients.
Pediatric: Dosage varies based on body weight and clinical response, administered via subcutaneous injection once weekly.
Geriatric: Not specifically studied; dosage adjustment may be necessary based on clinical response and tolerability.
Renal Impairment: No specific adjustments established; monitor closely.
Hepatic Impairment: No specific adjustments established; use with caution.
Pharmacokinetics
Absorption: Absorbed via subcutaneous injection with a slow release.
Distribution: Distributed throughout bodily tissues; specific volume not well established.
Metabolism: Partially metabolized in the liver and other tissues.
Excretion: Metabolites excreted primarily via renal pathways.
Half Life: Approximately 25 hours after subcutaneous injection.
Contraindications
- Active malignancy
- Hypersensitivity to any component of the product
Precautions
- Monitor for increased intracranial pressure, edema, and signs of intracranial hypertension; evaluate for scoliosis progression; check for glucose intolerance or diabetes; use with caution in patients with underlying eye disease or tumors.
Adverse Reactions - Common
- Injection site reactions (Common)
- Headache (Common)
- Arthralgia (Common)
Adverse Reactions - Serious
- Intracranial hypertension (Less common)
- Progression of scoliosis (Less common)
- Hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Glucocorticoids may attenuate growth-promoting effects.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor growth velocity, check IGF-1 levels, assess for side effects like edema or headache.
Diagnoses:
- Risk for impaired growth
- Risk for intracranial hypertension
Implementation: Administer subcutaneously as prescribed, rotate injection sites, educate patient on injection technique and side effects.
Evaluation: Assess growth response, monitor for adverse effects, adjust dose as needed.
Patient/Family Teaching
- Administer injections as instructed, rotate injection sites, report any severe headaches, visual changes, or signs of allergic reactions.
- Understand the importance of regular follow-up visits for monitoring growth and side effects.
- Do not alter dose without medical advice.
Special Considerations
Black Box Warnings:
- None specifically identified for Lonapegsomatropin.
- However, growth hormone therapies are associated with increased risk of neoplasia; monitor regularly.
Genetic Factors: Response to therapy may vary based on underlying genetic conditions affecting growth.
Lab Test Interference: May affect serum glucose, thyroid function tests, and IGF-1 levels.
Overdose Management
Signs/Symptoms: Signs of overdose may include increased intracranial pressure, new or worsening scoliosis, or signs of hypoglycemia/hyperglycemia.
Treatment: Discontinue medication, provide supportive care, monitor blood glucose, and intracranial pressure as needed.
Storage and Handling
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F).
Stability: Stable until the expiration date when stored properly; protect from light.