To avoid embryo-fetal exposure, REVLIMID is only available through a restricted distribution program called the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program. The Lenalidomide REMS program requires prescribers and pharmacies to be certified and patients to enroll and comply with all of the program requirements.
To enroll yourself and your patients, receive more information, and download forms related to the Lenalidomide REMS program, please visit LenalidomideREMS.com.
Important Information about Lenalidomide REMS
- REVLIMID can cause fetal harm when administered to a pregnant woman, and is contraindicated in pregnant females or females capable of becoming pregnant
- To avoid embryo-fetal exposure, REVLIMID is only available under a restricted distribution program called “Lenalidomide Risk Evaluation and Mitigation Strategy”
- Prescribers and pharmacies certified with Lenalidomide REMS can prescribe and dispense the product to patients who are enrolled and meet all the conditions of the Lenalidomide REMS program
- Female patients of reproductive potential must use at least one highly effective method of contraception and at least one additional method, concurrently, every time they have sex with a male
- If pregnancy does occur, REVLIMID must be immediately discontinued. Any suspected embryo-fetal exposure to REVLIMID must be reported immediately to the FDA via the MedWatch number at 1-800-FDA-1088, and also to the REMS Call Center at 1-888-423-5436. The patient should be referred to an OB/GYN experienced in reproductive toxicity
- Male patients must be instructed to use a latex or synthetic condom every time they have sexual intercourse with a female of reproductive potential
- Instruct patients to return unused REVLIMID capsules to Bristol Myers Squibb, their REVLIMID prescriber, or their REVLIMID-dispensing pharmacy for disposal