Hematologic Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies (REMS) are safety programs to manage the serious risks that can arise from certain drugs or biological products. If a drug or biological product has a high risk, REMS are established by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug will outweigh the risks. There are a number of hematologic therapies that require REMS. ASH is providing the following information to keep physicians apprised of the resources available for hematology-related REMS programs.

The FDA REMS Resource webpage provides background about REMS and the therapies that require them. 

• View the newly launched REMS Public Dashboard, an interactive web-based tool that allows for analysis and visualization of the REMS data files.

The following list provides information about the hematologic therapies that require REMS and links for providers about their respective REMS programs.

Duvelisib (Copiktra)

Visit the Copiktra website on Duvelisib REMS.

Elrexfio (elranatamab-bcmm)

Visit the Elrexfio website on Elrexfio REMS.

Pomalidomide (Pomalyst)

Visit the Pomalyst website on Pomalidomide REMS.

Lenalidomide (Revlimid)

Visit the Revlimid website on Lenlidomide REMS.

Thalidomide (Thalomid)

Visit the Thalomid website on Thalidomide REMS.