PALOPEGTERIPARATIDE INJ,SOLN
Clinical Criteria Summary
Indication
- Hypoparathyroidism in adults
Patient Population & Clinical Scenarios
- Adults with hypo-PTH Dx for at least 26 weeks and on stable doses of ≥0.5 mcg calcitriol and >800 mg/d calcium
- Patients refractory to standard care with therapeutic doses of calcium and calcitriol
- Specific clinical scenarios where patients may benefit:
- Hyperphosphatemia
- Corrected calcium below target levels or symptomatic hypocalcemia
- Hypercalcuria or nephrolithiasis despite thiazide use
- Malabsorption syndromes
- Declining eGFR
- ED visit or hospitalization for hypocalcemia or requiring IV calcium in any setting
Dosing & Administration
- Initial dose: 18 mcg subcutaneously once daily
- Dose adjustments: In 3 mcg increments based on serum calcium levels, supplemental calcitriol, and supplemental calcium doses
- Maximum dose: 30 mcg/day
Monitoring Requirements
- Periodically measure serum calcium and monitor for signs/symptoms of hypercalcemia and hypocalcemia
- Monitor for signs/symptoms of orthostatic hypotension
- Measure serum calcium and digoxin levels frequently if concomitant use may predispose to digoxin toxicity with hypercalcemia
- Measure serum calcium more frequently when used with other drugs known to affect serum calcium levels
Contraindications & Precautions
- Severe hypersensitivity to palopegteriparatide or any of its excipients
- Not recommended in patients at increased risk of osteosarcoma