YORVIPATH

What it is

Yorvipath (palopegteriparatide) is a parathyroid hormone (PTH) analogue indicated for the treatment of chronic hypoparathyroidism in adults. Yorvipath is supplied as a solution for injection in pre-filled pen. Three strengths are available: 168 micrograms per 0.56 mL, 294 micrograms per 0.98 mL, and 420 micrograms per 1.4 mL.

Approved indications

— Chronic hypoparathyroidism in adults.

Dosing overview

The recommended starting dose is 18 micrograms once daily with dose adjustments in 3 micrograms increments every 7 days, with a dose range of 6 to 60 micrograms per day. The dose should be individualised based on albumin-adjusted serum calcium, with the optimal dose after titration being the minimum dose required to prevent hypocalcaemia and maintain serum calcium within the normal range. Yorvipath must be administered as a subcutaneous injection to the abdomen or front of the thigh. All doses above 30 micrograms per day should be administered as two single doses injected sequentially at different injection sites.

Key safety warnings

Before initiating Yorvipath, serum 25(OH) vitamin D should be within the normal range and albumin-adjusted serum calcium should be stable within or slightly below the normal range of 1.95 to 2.64 mmol/L, with each confirmed on at least one laboratory value within two weeks prior to the first dose. Albumin-adjusted serum calcium concentration must be monitored during titration, and Yorvipath dose may be increased in increments of 3 micrograms only if at least 7 days have elapsed since a prior dose change. Once the Yorvipath maintenance dose is achieved, serum calcium should be measured as indicated for symptoms of hypocalcaemia or hypercalcaemia, and regular monitoring of serum calcium should generally occur at least once every 6 weeks. If albumin-adjusted serum calcium becomes very high (≥3.00 mmol/L), Yorvipath should be withheld for 2 to 3 days and then serum calcium rechecked; if it remains elevated, Yorvipath should be withheld for an additional 2 to 3 days. Interruption of daily administration should be avoided to minimise serum PTH fluctuations, as interruption or discontinuation of treatment can result in hypocalcaemia; if Yorvipath treatment is interrupted or discontinued for 3 or more consecutive doses, patients should be monitored for signs and symptoms of hypocalcaemia and serum calcium should be considered.

Regulatory history

Yorvipath was first listed on the ARTG on 19 February 2025, with three registered variants across strengths 168 micrograms per 0.56 mL, 294 micrograms per 0.98 mL, and 420 micrograms per 1.4 mL. The TGA approved Yorvipath on 17 February 2025. The PBAC considered the application in March 2025 and July 2025, recommending against listing on both occasions.