Palopegteriparatide: New Drug for the Treatment of Chronic Hypoparathyroidism in Adults

Abstract

In August 2024, U.S. Food and Drug Administration approved palopegteriparatide for the treatment of hypoparathyroidism in adults and recommended for parathyroid hormone replacement therapy. It is a prodrug designed to provide prolong action and maintain serum level of parathyroid hormone (1-34), over 24 – hour period. It consequently maintains normocalcemia, normophosphatemia and normocalciuria. It is efficient to treat hypoparathyroidism and reduce the conventional therapy dosing, i.e. stop taking active vitamin D, and decrease taking elemental calcium to be ≤ 600 mg/day, and thus improve in drug compliance. Long-term adverse effects such as deterioration of hypercalciuria, renal insufficiency, ectopic calcification will also be decreased and will improve quality of life. Palopegteriparatide is administered once daily via subcutaneous injection, and the dosage should be individualized. The recommended starting dose is 18 mcg once daily. Dosage adjustments should be made in 3 mcg increments or decrements. Do not increase the dosage more often than every 7 days. Do not decrease the dosage more often than every 3 days. The recommended dosage range is 6 - 30 mcg once daily. Serum calcium should be measured within 7 to 10 days after initiating therapy or after any change in the dose of palopegteriparatide, active vitamin D, or calcium supplement, and monitor for clinical symptoms of hypocalcemia or hypercalcemia. The most common adverse reactions associated with palopegteriparatide (incidence ≥ 5%) include: injection site reactions (i.e. erythema, rash), vasodilatory signs and symptoms (i.e. orthostatic hypotension, dizziness, palpitations, postural orthostatic tachycardia syndrome), headache, diarrhea, back pain (i.e. back pain, flank pain, spinal pain), hypercalcemia, oropharyngeal pain.