Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 8/4/17

Natpara (parathyroid hormone) for Injection REMS

Goal of the Natpara (parathyroid hormone) for Injection REMS Program

The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:

a. ensuring that prescribers are educated on the following:
    • potential risk of osteosarcoma associated with the use of NATPARA
    • appropriate patient selection
    • safe-use conditions required for prescribing NATPARA

b. ensuring that NATPARA is dispensed only to patients informed about the potential risk of osteosarcoma associated with the use of NATPARA

REMS Elements

• Elements to Assure Safe Use

• Implementation System

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REMS Summary of Terms