Palopegteriparatide
Drug Details
- Generic Name
- Palopegteriparatide
- Brand Names
- Yorvipath
- Application Number
- NDA216490
- Sponsor
- Ascendis Pharma, Endocrinology, Inc.
- NDC Codes
- 4
- Dosage Forms
- INJECTION, SOLUTION, POWDER
- Routes
- SUBCUTANEOUS
- Active Ingredients
- PALOPEGTERIPARATIDE
Indications and Usage
1 INDICATIONS AND USAGE YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. ( 1 ) Limitations of Use : Not studied for acute post-surgical hypoparathyroidism. ( 1 ) Titration scheme 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. ( 1 ) Limitations of Use 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 [see Dosage and Administration (2.3 , 2.4) and Clinical Studies (14) ] .