Is there a Risk Management Plan in place for Revlimid?
Yes. The sponsor, Celgene Corporation, submitted a Risk Management Program to prevent pregnancy exposures to this drug. This program is called RevAssist. • Why is there a Risk Management Plan for Revlimid? Because of the potential for birth defects, exposure of a developing fetus to this product must be avoided. Revlimid will only be available under a special restricted distribution program approved by FDA. • What are the goals for RevAssist? The goals of the RevAssist plan are to: • Prevent fetal exposure to Revlimid by registering and educating all physicians, pharmacists and patients and monitoring pregnancy prevention activities. • Reduce the risk of fetal exposure from males taking Revlimid who engage in sexual contact with a female partner of child bearing potential. • Educate physicians, other healthcare providers, and patients about potential lowering in blood cell counts (cytopenias) associated with Revlimid therapy. • Will the labeling for Revlimid have a Black Box Warning or
