Risk Evaluation and Mitigation Strategy (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits outweigh its risks.

To learn more about serious risks, read the Important Safety Information and Medication Guide and discuss it with your patients.

The goals of REMS for ACTEMRA are:

• To inform healthcare providers about the risks of serious infections, gastrointestinal perforations, changes in liver function, decreases in peripheral neutrophil counts, decreases in platelet counts, elevations in lipid parameters in peripheral blood, demyelinating disorders, and malignancies associated with ACTEMRA
• To inform patients about the serious risks associated with ACTEMRA treatment

Genentech recommends laboratory monitoring of patients being treated with ACTEMRA due to the potential consequences of treatment-related abnormalities in liver function, lipids, neutrophils and platelets. If you become aware of a patient who has developed a serious adverse event while being treated with ACTEMRA, it is important that you report the case, even if you do not think there is a causal relationship. The information you provide about these events may inform therapy and monitoring decisions.

Continue to check back on this Web site; it will be updated to include additional information intended to assist in the proper communication of the risks and benefits of ACTEMRA.