Hematologic Risk Evaluation and Mitigation Strategies
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
The FDA REMS
Resource webpage provides background about REMS and the therapies that
following list provides information about the hematologic therapies that
require REMS and links for providers about their respective REMS programs.
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.
Visit the Blincyto website
on REMS or download a PDF of information from the FDA.
Visit the Ariad website on Iclusig REMS or download a PDF of information from the FDA
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- 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