NATPARA REMS Program
(Risk Evaluation and Mitigation Strategy)
What is the NATPARA REMS Program?
A REMS Program is a strategy to manage known or potential serious risks associated with a drug product, and it is required by the FDA to ensure the benefits of a drug outweigh its risks. The NATPARA REMS Program informs prescribers, pharmacists, and patients about the potential risk of:
- NATPARA causes an increase in the incidence of osteosarcoma in rats
- The increase in osteosarcoma in rats is dependent on NATPARA dose and treatment duration
NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
Because of the potential risk of osteosarcoma, NATPARA is only recommended for 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.
NATPARA is not a parathyroid hormone replacement.
NATPARA is only available through the NATPARA REMS Program.
The requirements include:
- Certification by completing training, including Knowledge Assessment, and enrollment into NATPARA REMS Program
- Patient Counseling on benefits and risks of NATPARA
- Completion of Patient-Prescriber Acknowledgment Form for each patient prior to initiation of treatment
- Provide patient with a copy of the completed Patient-Prescriber Acknowledgment Form and the NATPARA Patient Brochure
Pharmacies must designate an authorized Pharmacy Representative who will complete the certification process on behalf of the pharmacy:
- Certification by completing training, including the Knowledge Assessment, and enrolling into the NATPARA REMS Program
- Implementing the necessary staff training and processes to comply with the NATPARA REMS Program requirements including:
- Verifying that the prescriber is certified in NATPARA REMS Program
- Verifying that a Patient-Prescriber Acknowledgment Form is on record for patient and prescriber
If you have any questions, contact the NATPARA REMS Program Coordinating Center at 1-855-NATPARA.