The Letairis Risk Evaluation and Mitigation Strategy
A Risk Evaluation and Mitigation Strategy is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.
The purpose of the Letairis REMS Program is to:
- Inform prescribers, patients, and pharmacists about the risk of serious birth defects and safe-use conditions for Letairis
- Minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential prescribed Letairis
- Females who are pregnant must not be prescribed Letairis
- Females taking Letairis must not become pregnant
© 2014 Gilead Sciences, Inc. All rights reserved. REMS-LET-0008 October 2014
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