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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Hypoparathyroidism Treatment History

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Within 2 weeks of first dose, confirm albumin-corrected serum calcium is ≥ 7.8 mg/dL.

Prescriber Information

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YORVIPATH Prescription and Physician Signature

The recommended starting dose is 18 mcg once daily.
Quantity: 28 days

Dose is only to be adjusted per physician's instruction and may be titrated to the appropriate dose in increments or decrements of 3 mcg/day with the daily dose ranging from 6 to 30 mcg/day. Injections are administered subcutaneously once daily to the abdomen or front of the thigh while rotating the injection site daily.

Quantity: 28 days

PRESCRIBER AUTHORIZATION I certify that the information provided above is, to the best of my knowledge current, complete, and accurate and the therapy I have prescribed above is medically necessary for this patient and patient's records contain supporting documentation that substantiates the utilization and medical necessity of the therapy.

I have discussed A·S·A·P with my patient and my patient would like to be screened for eligibility for A·S·A·P and provided, if applicable, any services under A·S·A·P. I will comply with my own state-specific prescription requirements, such as e-prescribing, state-specific prescription form, fax language. I understand that noncompliance with state-specific requirements could result in outreach to the prescriber. I authorize the provision to patient of ancillary supplies, such as sharps containers and alcohol swabs, to administer the therapy. I acknowledge that the prescription may only be filled by a limited number of specialty pharmacies and prescriber authorizes Ascendis and those acting on its behalf to transmit the prescription electronically, by facsimile, or by mail to the appropriate dispensing specialty pharmacy.

Please note that the authorization you are providing is not a valid prescription. In order to complete your patient's enrollment, please submit an e-prescription to our program's pharmacy (NPI: 1699202838), or fax a written prescription to our program at 1-888-436-0193.

Injection Training

INJECTION TRAINING AUTHORIZATION A·S·A·P will provide my patient with training from a company-funded program on the proper self-administration of YORVIPATH. I will receive information on my patient's injection training via the fax number I provided above. This order is valid for 1 year. I will ensure my patient has received training by a healthcare professional prior to first use.

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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.

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