INDICATION AND LIMITATIONS OF USE

YORVIPATH (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.

YORVIPATH was not studied for acute post-surgical hypoparathyroidism. YORVIPATH’s 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.

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Dosing & Titration

Titration steps

YORVIPATH pen

Dosing and titrating YORVIPATH is carried out in 4 Steps1

Number one
EVALUATION1
  • Within 14 days before the first dose of YORVIPATH, confirm that your patient’s serum 25(OH) vitamin D is within the normal range and albumin-corrected serum calcium is ≥7.8 mg/dL1
Number two
INITIATION1
  • The recommended starting dose is 18 mcg once daily1
    • Use only 1 injection to achieve the once-daily recommended dosage
  • On the day of initiation or up-titration of YORVIPATH, doses of active vitamin D and calcium are adjusted based on albumin-corrected serum calcium levels and current active vitamin D intake1
    • If not taking active vitamin D, decrease calcium by ≥1500 mg or discontinue if current calcium dose is ≤1500 mg1

Active vitamin D (calcitriol) and calcium dose adjustments upon YORVIPATH initiation or up-titration if taking active vitamin D1

Measure albumin-corrected serum calcium

Albumin-corrected serum calcium ≥ 8.3 mg/dL

Albumin-corrected serum calcium <8.3 mg/dL

Active vitamin D >1 mcg/day

Reduce dose of active vitamin D by ≥50% and maintain current calcium dose

Active vitamin D ≤1 mcg/day

Discontinue active vitamin D and maintain current calcium dose

Reduce dose of active vitamin D by ≥50% and maintain current calcium dose

If calcium supplements are needed to meet dietary requirements, continuing dietary calcium supplements at elemental doses ≤ 600 mg/day may be considered instead of discontinuing entirely.1

Number three
TITRATION1
  • The goal of titrating YORVIPATH is to maintain normal serum calcium levels while achieving independence from conventional therapy1*
    • Dose adjustments should be made in 3-mcg increments or decrements

The YORVIPATH dose should not be1:

Increased more often than every 7 days

Decreased more often than every 3 days

  • Serum calcium should be measured within 7 to 10 days after the first dose and any dose change in YORVIPATH, active vitamin D, or calcium1
    • Follow the algorithm for appropriate titration of YORVIPATH, active vitamin D, and/or calcium
    • Monitor patients for clinical symptoms of hypocalcemia or hypercalcemia
Number four
MAINTENANCE1
  • The maximum recommended dosage of YORVIPATH is 30 mcg/day1
    • The dose range of YORVIPATH is 6 to 30 mcg/day. Do not administer a dose higher than 30 mcg or more than 1 injection per day
    • If calcium levels remain low with 30 mcg/day, consider adding or restarting calcium and/or active vitamin D therapy and/or seek other treatment options
  • Once the maintenance dosage is achieved, continue to monitor for clinical signs and symptoms of hypocalcemia or hypercalcemia1
  • Measure serum calcium levels at a minimum of every 4 to 6 weeks or as indicated as some patients may require further dose titration1

YORVIPATH Titration Algorithm

The goal of titrating YORVIPATH is to maintain normal calcium levels while achieving independence from conventional therapy.1*

Use the full titration algorithm to help determine the dose adjustment of YORVIPATH, active vitamin D, and/or calcium based on your patient’s albumin-corrected serum calcium level1:

Download the full titration algorithm here.

Use the titration guide below to help you adjust the dose of YORVIPATH, active vitamin D, and/or calcium based on your patient’s albumin-corrected serum calcium level1:

Low albumin-corrected serum calcium icon

Albumin-corrected serum calcium low (<8.3 mg/dL)1

low serum calcium titration table
Normal albumin-corrected serum calcium icon

Albumin-corrected serum calcium normal (8.3 to 10.6 mg/dL)1

normal calcium serum titration table
† If dose of active vitamin D is >1 mcg/day, reduce dose by ≥50% and maintain current calcium dose. If dose of active vitamin D is ≤1 mcg/day, discontinue active vitamin D and maintain current calcium dose.1
High albumin-corrected serum calcium icon

Albumin-corrected serum calcium high (10.7 to 11.9 mg/dL)1

high calcium serum titration table
† If dose of active vitamin D is >1 mcg/day, reduce dose by ≥50% and maintain current calcium dose. If dose of active vitamin D is ≤1 mcg/day, discontinue active vitamin D and maintain current calcium dose.1
Very high albumin-corrected serum calcium icon

Albumin-corrected serum calcium very high (≥12 mg/dL)1

very high calcium serum titration table
* Independence from conventional therapy was defined as not requiring active vitamin D (eg, calcitriol) or therapeutic calcium doses (>600 mg/day).1
Doctor Warren

See Dr. Mark Warren present an overview of dosing and titrating YORVIPATH.

Watch video

Dr. Mark Warren, Associate Professor, Campbell University School of Medicine Director of Clinical Trials and Laboratory Services, Physicians East, PA

This guide can help with dosing and titrating YORVIPATH for your patients

Download guide

See also

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INDICATION AND LIMITATIONS OF USE

YORVIPATH (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.

  • YORVIPATH was not studied for acute post-surgical hypoparathyroidism.
  • YORVIPATH’s 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.

Important Safety Information

CONTRAINDICATIONS

YORVIPATH is contraindicated in patients with severe hypersensitivity to palopegteriparatide or to any of its excipients. Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been observed with parathyroid hormone (PTH) analogs.

Important Safety Information

INDICATION AND LIMITATIONS OF USE

YORVIPATH (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.

  • YORVIPATH was not studied for acute post-surgical hypoparathyroidism.
  • YORVIPATH’s 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.

CONTRAINDICATIONS

YORVIPATH is contraindicated in patients with severe hypersensitivity to palopegteriparatide or to any of its excipients. Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been observed with parathyroid hormone (PTH) analogs.

WARNINGS AND PRECAUTIONS

Risk of Unintended Changes in Serum Calcium Levels Related to Number of Daily Injections

Use only one YORVIPATH injection to achieve the recommended once daily dosage. Using two YORVIPATH injections to achieve the recommended once daily dosage increases the variability of the total delivered dose, which can cause unintended changes in serum calcium levels, including hypercalcemia and hypocalcemia.

Serious Hypercalcemia

Serious events of hypercalcemia requiring hospitalization have been reported with YORVIPATH. The risk is highest when starting or increasing the dose of YORVIPATH but may occur at any time. Measure serum calcium 7 to 10 days after any dose change or if there are signs or symptoms of hypercalcemia, and at a minimum of every 4 to 6 weeks once the maintenance dose is achieved. Treat hypercalcemia if needed. If albumin-corrected serum calcium is greater than 12 mg/dL, withhold YORVIPATH for at least 2-3 days. For less serious hypercalcemia, adjust the dose of YORVIPATH, active vitamin D, and/or calcium supplements.

Serious Hypocalcemia

Serious events of hypocalcemia have been observed with PTH products, including YORVIPATH. The risk is highest when YORVIPATH is abruptly discontinued, but may occur at any time, even in patients who have been on stable doses of YORVIPATH. Measure serum calcium 7 to 10 days after any dose change or if there are signs or symptoms of hypocalcemia, and at a minimum of every 4 to 6 weeks once the maintenance dosage is achieved. Treat hypocalcemia if needed, and adjust the dose of YORVIPATH, active vitamin D, and/or calcium supplements if hypocalcemia occurs.

Potential Risk of Osteosarcoma

YORVIPATH is a PTH analog. An increased incidence of osteosarcoma (a malignant bone tumor) has been reported in male and female rats treated with PTH analogs, including teriparatide. Osteosarcoma occurrence in rats is dependent on teriparatide or PTH dose and treatment duration. Osteosarcoma has been reported in patients treated with teriparatide in the postmarketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of teriparatide use.

YORVIPATH is not recommended in patients who are at increased risk of osteosarcoma, such as patients with:

  • Open epiphyses. YORVIPATH is not approved in pediatric patients.
  • Metabolic bone diseases other than hypoparathyroidism, including Paget’s disease of bone.
  • Unexplained elevations of alkaline phosphatase.
  • Bone metastases or a history of skeletal malignancies.
  • History of external beam or implant radiation therapy involving the skeleton.
  • Hereditary disorders predisposing to osteosarcoma.

Instruct patients to promptly report clinical symptoms (e.g., persistent localized pain) and signs (e.g., soft tissue mass tender to palpation) that could be consistent with osteosarcoma.

Orthostatic Hypotension

Orthostatic hypotension has been reported with YORVIPATH. Associated signs and symptoms may include decreased blood pressure, dizziness (including postural dizziness), palpitations, tachycardia, presyncope, or syncope. Such symptoms can be managed by dosing at bedtime, while reclining. YORVIPATH should be administered initially when the patient can sit or lie down due to the potential of orthostatic hypotension.

Risk of Digoxin Toxicity with Concomitant Use of Digitalis Compounds

YORVIPATH increases serum calcium, and therefore, concomitant use with digoxin (which has a narrow therapeutic index) may predispose patients to digitalis toxicity if hypercalcemia develops. Digoxin efficacy may be reduced if hypocalcemia is present. When YORVIPATH is used concomitantly with digoxin, measure serum calcium and digoxin levels routinely, and monitor for signs and symptoms of digoxin toxicity. Refer to the digoxin prescribing information for dose adjustments, if needed.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) in patients treated with YORVIPATH were injection site reactions (39%), vasodilatory signs and symptoms (28%), headache (21%), diarrhea (10%), back pain (8%), hypercalcemia (8%) and oropharyngeal pain (7%).

DRUG INTERACTIONS

Drugs Affected by Serum Calcium

Digoxin: YORVIPATH increases serum calcium, therefore, concomitant use with digoxin (which has a narrow therapeutic index) may predispose patients to digitalis toxicity if hypercalcemia develops. Digoxin efficacy may be reduced if hypocalcemia is present. When YORVIPATH is used concomitantly with digoxin, measure serum calcium and digoxin levels, and monitor for signs and symptoms of digoxin toxicity. Adjustment of the digoxin and/or YORVIPATH dose may be needed.

Drugs Known to Affect Serum Calcium

Drugs that affect serum calcium may alter the therapeutic response to YORVIPATH. Measure serum calcium more frequently when YORVIPATH is used concomitantly with these drugs, particularly after these drugs are initiated, discontinued, or dose adjusted.

USE IN SPECIFIC POPULATIONS

Pregnancy

Available data from reports of pregnancies in the clinical trials from drug development are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If YORVIPATH is administered during pregnancy, or if a patient becomes pregnant while receiving YORVIPATH, healthcare providers should report YORVIPATH exposure by calling 1‑844‑442‑7236.

Lactation

Monitor infants breastfed by females treated with YORVIPATH for symptoms of hypercalcemia or hypocalcemia. Consider monitoring serum calcium in the breastfed infant.

You are encouraged to report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1‑844‑442‑7236.

Please click here for full Prescribing Information for YORVIPATH.

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