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SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS › CALCIUM HOMEOSTASIS › PARATHYROID HORMONES AND ANALOGUES › Parathyroid hormones and analogues
palopegteriparatide
H05AA05
Forms & Strengths
- Subcutaneous injection: 4.5 mg/1.5 mL (3 mg/mL)
- Subcutaneous injection: 9 mg/1.5 mL (6 mg/mL)
- Subcutaneous injection: 14 mg/1.5 mL (9.3 mg/mL)
- Subcutaneous injection: 18 mg/1.5 mL (12 mg/mL)
- Subcutaneous injection: 22.5 mg/1.5 mL (15 mg/mL)
Adult Dosing
- Initial dose: 18 mcg (delivered as PTH[1-33]) subcutaneously once daily
- Titration: Adjust dose by 4.5 mcg increments based on serum calcium and urine calcium levels
- Target: Maintain serum calcium within the lower half of the normal range and maintain 24-hour urinary calcium excretion within normal limits
Pediatric Dosing
- Safety and efficacy not established in pediatric patients
- Not recommended for use in children with open epiphyses due to risk of osteosarcoma observed in animal studies with related PTH analogs
Indications
- Treatment of hypoparathyroidism in adults
Mechanism of Action
- Prodrug of teriparatide (PTH[1-33]), a recombinant human parathyroid hormone analog
- Binds to and activates the parathyroid hormone 1 receptor (PTH1R)
- Restores extracellular calcium homeostasis by promoting renal tubular calcium reabsorption, enhancing intestinal calcium absorption via vitamin D activation, and regulating bone turnover
Contraindications
- History of hypersensitivity to palopegteriparatide or teriparatide products
- Patients with baseline elevated risk for osteosarcoma (e.g., Paget's disease of bone, unexplained elevations of alkaline phosphatase, open epiphyses, prior radiation therapy involving the skeleton)
- Severe renal impairment (eGFR <30 mL/min/1.73m2) or end-stage renal disease
Adverse Reactions
- Injection site reactions (pain, erythema, pruritus)
- Hypercalcemia
- Hypocalcemia
- Headache
- Nausea
- Diarrhea
- Arthralgia
- Pain in extremity
- Paresthesia
- Vomiting
Drug Interactions
- Digitalis glycosides (digoxin): Hypercalcemia may precipitate cardiac arrhythmias
- Vitamin D analogs and calcium supplements: Concomitant use increases the risk of hypercalcemia; doses may need reduction
- Thiazide diuretics: May decrease urinary calcium excretion and increase the risk of hypercalcemia
Curated Content: Needs Vetting Before Put to Clinical Use