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.
Belantamab Mafodotin (Blenrep)
Visit the Blenrep website on Duvelisib REMS or download a PDF of information from the FDA.
Visit the Copiktra website on Duvelisib REMS or download a PDF of information from the FDA.
On April 13, 2017 the FDA announced the elimination of the REMS for Aranesp.
Epoetin Alfa (Epogen)
On April 13, 2017 the FDA announced the elimination of the REMS for Epogen/Procrit.
Visit the Pomalyst website on Pomalidomide REMS or download a PDF of information from the FDA.
Visit the Revlimid website on Lenlidomide REMS or download a PDF of information from the FDA.
Visit the Thalomid website on Thalidomide REMS or download a PDF of information from the FDA.
- High-Cost Hematologic Drug Access
Resources to help clinicians and patients access high-cost hematologic drugs
- FDA Alerts
Information about newly approved therapies and other important actions (e.g., updated safety information, new prescribing information) for patients provided in collaboration with the Food and Drug Administration (FDA)
- Hematologic Drug Shortage Information
Information and resources regarding shortages of drugs used to treat patients with hematologic diseases