Drug Guide
Palopegteriparatide
Classification
Therapeutic: Bone Resorption Inhibitor / Anabolic Agent
Pharmacological: Recombinant Parathyroid Hormone Analog
FDA Approved Indications
- Treatment of osteoporosis in postmenopausal women and men at high risk for fracture
Mechanism of Action
Palopegteriparatide is a recombinant form of parathyroid hormone that stimulates bone formation by activating osteoblasts, thereby increasing bone mass and strength.
Dosage and Administration
Adult: Typically, 20 mcg administered subcutaneously once daily. Specific dosing and duration depend on patient response and clinical judgment.
Pediatric: Not approved for use in pediatric populations.
Geriatric: Use with caution; adjust dose based on renal function and patient tolerability.
Renal Impairment: Adjust dose or monitor closely in patients with renal impairment.
Hepatic Impairment: No specific adjustments are generally required.
Pharmacokinetics
Absorption: Rapid subcutaneous absorption.
Distribution: Widely distributed with a small volume of distribution.
Metabolism: Degraded by proteolytic enzymes; not metabolized by cytochrome P450 enzymes.
Excretion: Excreted as amino acids and peptides via the renal route.
Half Life: Approximately 1 hour.
Contraindications
- Hypersensitivity to Palopegteriparatide or any component of the formulation.
- Paget's disease involving the skeleton.
- Bone cancer or an unexplained elevated alkaline phosphatase.
- History of radiation therapy involving the skeleton.
Precautions
- Use cautiously in patients with hypercalcemia, kidney stones, or a history of skeletal malignancies. Monitor serum calcium during therapy.
Adverse Reactions - Common
- Nausea (Common)
- Leg cramps (Common)
- Orthostatic hypotension (Common)
Adverse Reactions - Serious
- Hypercalcemia (Less common)
- Osteosarcoma (animal studies concern, no confirmed cases in humans) (Rare)
Drug-Drug Interactions
- NO specific interactions identified; caution with other drugs affecting calcium or bone metabolism.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor calcium levels, renal function, and signs of adverse effects.
Diagnoses:
- Risk for fractures
- Altered calcium metabolism
Implementation: Administer subcutaneously as prescribed, rotate sites, and educate patient on proper injection technique.
Evaluation: Assess for effectiveness in increasing bone density and monitor for adverse effects.
Patient/Family Teaching
- Take as directed; do not exceed prescribed dose.
- Report symptoms of hypercalcemia, severe bone pain, or new or worsening bone pain.
- Maintain adequate hydration.
- Follow-up appointments for monitoring.
- Avoid high-impact activities during initial treatment phase.
Special Considerations
Black Box Warnings:
- Potential risk of osteosarcoma; use only for indicated duration and patient population.
- Not recommended for patients at increased risk for osteosarcoma.
Genetic Factors: N/A
Lab Test Interference: May increase serum calcium levels, affecting diagnostic tests.
Overdose Management
Signs/Symptoms: Severe hypercalcemia, nausea, vomiting, weakness.
Treatment: Discontinue medication, administer IV hydration, and manage hypercalcemia with bisphosphonates or other appropriate therapies.
Storage and Handling
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep in original carton to protect from light.
Stability: Stable for up to 14 days at room temperature if refrigeration is not available.