Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

Exclusion Criteria

• •Diagnosis of pseudohypoparathyroidism.
• •Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1.
• •Severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73m2).
• •Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton
• •Active malignancy within past 2 years excluding successfully resected thyroid carcinoma and non-melanoma skin cancer.
• •Severe or decompensated cardiac disease within 26 weeks, including but not limited to class IV or Stage D heart failure, unstable angina, myocardial infarction or uncontrolled arrhythmias.
• •Pregnant or lactating females, or females intending to become pregnant.
• •Known allergy and/or sensitivity to palopegteriparatide or its excipients or prior PTH therapy.