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Long-acting parathyroid hormone (1-34) prodrug Pregnancy: US labelling: available data from pregnancies reported in clinical trials are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are disease-associated risks to mother and fetus related to hypocalcaemia in pregnancy. In animal reproduction studies in rats and rabbits, no significant adverse effects were seen at up to 16- and 13-fold the maximum recommended human dose respectively.

Palopegteriparatide

Brand names: Yorvipath

Palopegteriparatide is a long-acting prodrug of parathyroid hormone (PTH 1-34) used as replacement therapy for adults with chronic hypoparathyroidism.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 18 micrograms (mcg) once daily (recommended starting dosage); recommended dosage range 6 to 30 micrograms once daily
Route: Subcutaneous injection
Frequency: Once daily
Max: 30 micrograms (mcg) subcutaneously once daily
No UK SPC (eMC) in the bundle — figures are from US prescribing information (YORVIPATH, Ascendis Pharma, label date 2026-04-21). Use ONLY ONE injection to achieve the once-daily dose; using two injections to make up the dose increases variability of the delivered dose and the risk of unintended hypocalcaemia or hypercalcaemia. Titration: adjust in 3 microgram increments or decrements, with the goal of maintaining serum calcium within the normal range without the need for active vitamin D (e.g. calcitriol) or therapeutic calcium doses (elemental calcium above 600 mg/day); calcium supplementation sufficient to meet daily dietary requirements may continue. Do not increase the dose more often than every 7 days; do not decrease more often than every 3 days. Before the first dose (within 2 weeks): confirm serum 25(OH) vitamin D is within the normal range and albumin-corrected serum calcium is 7.8 mg/dL or above. Monitoring: measure serum calcium 7 to 10 days after the first dose and after any change in the dose of this drug, active vitamin D or calcium supplements; once the maintenance dosage is achieved, measure serum calcium at least every 4 to 6 weeks, or as indicated by symptoms. Advise patients to monitor daily for signs and symptoms of hypocalcaemia or hypercalcaemia. On the day of initiation or up-titration, adjust active vitamin D and calcium supplements per label Table 1 (e.g. albumin-corrected serum calcium 8.3 mg/dL or above on more than 1 microgram/day calcitriol — reduce calcitriol by at least 50%; on 1 microgram/day or less — discontinue calcitriol; not on active vitamin D — reduce calcium by at least 1500 mg/day or discontinue if the current daily dose is 1500 mg/day or less). If albumin-corrected serum calcium is 12 mg/dL or greater, withhold for 2 to 3 days then recheck. If an adequate response is not achieved at the maximum 30 micrograms once daily, consider adding or restarting calcium and/or active vitamin D therapy and/or other treatment options. Some patients may require a dose increase over time to maintain the same therapeutic effect. Paediatric: safety and effectiveness have not been established in paediatric patients. Prefilled pens: 168 mcg/0.56 mL pen delivers labelled doses of 6, 9 or 12 mcg; 294 mcg/0.98 mL pen delivers 15, 18 or 21 mcg; 420 mcg/1.4 mL pen delivers 24, 27 or 30 mcg.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Severe hypersensitivity to palopegteriparatide or to any of its excipients (hypersensitivity reactions including anaphylaxis, angioedema and urticaria have been observed with parathyroid hormone analogues)

Side effects

  • Injection site reactions
  • Vasodilatory signs and symptoms
  • Headache
  • Diarrhoea
  • Back pain
  • Hypercalcaemia and oropharyngeal pain

Interactions

  • Digoxin — this drug raises serum calcium, and concomitant use may predispose to digitalis toxicity if hypercalcaemia develops; digoxin efficacy may be reduced if hypocalcaemia is present. Measure serum calcium and digoxin levels, monitor for digoxin toxicity, and adjust either dose as needed
  • Drugs known to affect serum calcium — may alter the therapeutic response; measure serum calcium more frequently, particularly when such drugs are started, stopped or dose-adjusted

Clinical monograph

How it works

It is a sustained-release form of teriparatide (a PTH analogue) that provides continuous parathyroid hormone receptor activity, regulating calcium and phosphate homeostasis and reducing reliance on calcium and active vitamin D supplements.

Prescribing in practice

  • Calcium levels must be closely monitored when starting and adjusting therapy, as changes can cause hypercalcaemia or hypocalcaemia, with active vitamin D and calcium supplements titrated accordingly.
  • It is given by once-daily subcutaneous injection as replacement, distinct from intermittent PTH analogues used for osteoporosis.
  • Conventional calcium and active vitamin D therapy is typically reduced as PTH replacement takes effect, guided by serum calcium.

Monitoring

Monitor serum calcium (and phosphate and vitamin D) regularly, especially during initiation and dose adjustment, with supplements titrated to maintain calcium in the target range.

Counselling the patient

  • Inject once daily as instructed and attend regular blood tests for calcium.
  • Your calcium and vitamin D supplements will likely be adjusted as treatment is established.
  • Report symptoms of high or low calcium such as tingling, cramps, nausea or excessive thirst.

Evidence & guidelines

Palopegteriparatide is approved as PTH replacement for chronic hypoparathyroidism on the basis of trials showing maintenance of normal calcium with reduced conventional therapy.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.