FDA approved Yorvipath (palopegteriparatide) for Hypoparathyroidism in AdultsFDA approved Yorvipath, a new daily injection for adults with hypoparathyroidism.

Yorvipath is a parathyroid hormone analog (PTH(1-34)) that acts as a parathyroid hormone receptor agonist, mimicking the actions of endogenous parathyroid hormone to regulate calcium and phosphate homeostasis.

Yorvipath is indicated for the treatment of hypoparathyroidism in adults. Limitations of use: Not studied for acute post-surgical hypoparathyroidism. The titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment.

The recommended starting dosage is 18 mcg subcutaneously 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 more often than every 3 days. The recommended dosage range is 6 to 30 mcg once daily. Use only one injection to achieve the once daily recommended dosage. Individualize dosage based on serum calcium. On the day of initiation or up-titration, adjust active vitamin D and calcium supplements based on albumin-corrected serum calcium and current active vitamin D intake (see Table 1 in label). Measure serum calcium 7 to 10 days after the first dose and after any dose change. Once maintenance dosage is achieved, measure serum calcium at least every 4 to 6 weeks.

Trial data not available in label.

No contraindications are listed in the label. Warnings and precautions include the risk of unintended changes in serum calcium levels (hypocalcemia and hypercalcemia) if two injections are used to achieve the recommended once daily dosage. If an adequate response is not achieved with a maximum dosage of 30 mcg, consider adding or restarting calcium and/or active vitamin D therapy and/or seek other treatment options.

Yorvipath provides a new treatment option for adults with hypoparathyroidism. It is not studied for acute post-surgical hypoparathyroidism. The titration scheme is only evaluated in patients who first achieved a serum calcium of at least 7.8 mg/dL with conventional therapy. Clinicians should consider Yorvipath for patients who have achieved initial calcium stabilization with calcium and active vitamin D, and who require ongoing management of chronic hypoparathyroidism.