tients that if they miss a dose of REVLIMID, they may still take it up to 12 hours after the time they would normally take it. If more than 12 hours have elapsed, they should be instructed to skip the dose for that day. The next day, they should take REVLIMID at the usual time. Warn patients to not take 2 doses to make up for the one that they missed.
Manufactured for: Celgene Corporation
Summit, NJ 07901
REVLIMID®, REVLIMID REMS® and THALOMID® are registered trademarks of Celgene Corporation.
Pat. www.celgene.com/therapies
©2005-2017 Celgene Corporation, All Rights Reserved.
MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2017
MEDICATION GUIDE
REVLIMID® (rev-li-mid)
(lenalidomide)
capsules
What is the most important information I should know about REVLIMID?
Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.
REVLIMID may cause serious side effects including:
Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.
REVLIMID is similar to the medicine thalidomide (THALOMID®). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.
Females must not get pregnant: For at least 4 weeks before starting REVLIMID
While taking REVLIMID
During any breaks (interruptions) in your treatment with REVLIMID
For at least 4 weeks after stopping REVLIMID
Females who can become pregnant: Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.
Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with REVLIMID.
If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.
If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088, and
Celgene Corporation at 1-888-423-5436
There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnanc
