NATPARA
NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D for the control of hypocalcemia in patients with hypoparathyroidism. Due to the potential risk of osteosarcoma, the drug is reserved for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Use of this therapy has not been studied in patients with acute post-surgical hypoparathyroidism or in those with calcium-sensing receptor mutations.
How NATPARA Works
NATPARA functions as a parathyroid hormone to raise serum calcium levels through three primary mechanisms. It increases the reabsorption of calcium within the renal tubules and enhances intestinal calcium absorption by converting 25-OH vitamin D to its active form. Additionally, the medication increases bone turnover, which releases calcium from the bone into the systemic circulation.
Details
- Status
- Prescription
- First Approved
- 2015-01-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NATPARA Approval History
What NATPARA Treats
2 indicationsNATPARA is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypocalcemia
- Hypoparathyroidism
NATPARA Boxed Warning
POTENTIAL RISK OF OSTEOSARCOMA In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor). The occurrence of osteosarcoma was dependent on parathyroid hormone dose and treatment duration. This effect was observed at parathyroid hormone exposure levels ranging from 3 to 71 times the exposure levels in humans receiving a 100 mcg dose of NATPARA. These data could not exclude a risk to humans [see Warnings and Precautions (5.1) , Nonclin...
WARNING: POTENTIAL RISK OF OSTEOSARCOMA In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor). The occurrence of osteosarcoma was dependent on parathyroid hormone dose and treatment duration. This effect was observed at parathyroid hormone exposure levels ranging from 3 to 71 times the exposure levels in humans receiving a 100 mcg dose of NATPARA. These data could not exclude a risk to humans [see Warnings and Precautions (5.1) , Nonclinical Toxicology (13.1) ]. Because of a potential risk of osteosarcoma, use NATPARA only in patients who cannot be well-controlled on calcium and active forms of vitamin D alone and for whom the potential benefits are considered to outweigh this potential risk [see Indications and Usage (1) , Warnings and Precautions (5.1) ]. Avoid use of NATPARA in patients who are at increased baseline risk for osteosarcoma, such as patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, patients with hereditary disorders predisposing to osteosarcoma or patients with a prior history of external beam or implant radiation therapy involving the skeleton [see Warnings and Precautions (5.1) ]. Because of the risk of osteosarcoma, NATPARA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NATPARA REMS Program [see Warnings and Precautions (5.2) ] . WARNING: POTENTIAL RISK OF OSTEOSARCOMA See full prescribing information for complete boxed warning. In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. A risk to humans could not be excluded ( 5.1 , 13.1 ) Because of the potential risk of osteosarcoma, prescribe NATPARA only to patients who cannot be well-controlled on calcium and active forms of vitamin D and for whom the pot
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NATPARA FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 ] . 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 indicat...
WARNING: POTENTIAL RISK OF OSTEOSARCOMA In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor). The occurrence of osteosarcoma was dependent on parathyroid hormone dose and treatment duration. This effect was observed at parathyroid ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.