PARATHYROID HORMONE
Drug Details
- Generic Name
- PARATHYROID HORMONE
- Brand Names
- NATPARA (parathyroid hormone)
- Application Number
- BLA125511
- Sponsor
- Takeda Pharmaceuticals America, Inc.
- NDC Codes
- 4
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- PARATHYROID HORMONE
Indications and Usage
1 INDICATIONS AND USAGE NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Limitations of Use Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone [see Warnings and Precautions (5.1) ] . NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism. NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. ( 1 ) Limitations of Use Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. ( 5.1 ) NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism.