p the dose for that day. The next day, they should take Pomalyst at the usual time. Warn patients not to take 2 doses to make up for the one that they missed.
Other Information
Advise patients who smoke to stop because smoking may reduce the efficacy of pomalidomide [see Drug Interactions (7.2)].
Manufactured for: Celgene Corporation
Summit, NJ 07901
Pomalyst®, REVLIMID® and THALOMID® are registered trademarks of Celgene Corporation.
Pomalyst REMS™ is a trademark of Celgene Corporation.
U.S. Pat. Nos. 5,635,517; 6,045,501; 6,315,720; 6,316,471; 6,476,052; 6,561,976; 6,561,977; 6,755,784; 6,908,432; 8,158,653; 8,198,262; 8,204,763; 8,315,886
©2005-2013Celgene Corporation, All Rights Reserved.
POMPI.001/MG.001 02/13
MEDICATION GUIDE
Pomalyst (POM-uh-list)
(pomalidomide)
capsules
Read the Medication Guide that comes with Pomalyst before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Pomalyst?
•Before you begin taking Pomalyst, you must read and agree to all of the instructions in the Pomalyst REMS™ program.
•Pomalyst 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 Pomalyst.
Pomalyst is similar to the medicine thalidomide (THALOMID). We know thalidomide can cause severe life-threatening birth defects. Pomalyst has not been tested in pregnant women. Pomalyst has harmed unborn animals in animal testing.
Females must not get pregnant:
◦for at least 4 weeks before starting Pomalyst
◦while taking Pomalyst
◦during any breaks (interruptions) in your treatment with Pomalyst
◦for at least 4 weeks after stopping Pomalyst
If you become pregnant while taking Pomalyst, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to:
◦FDA MedWatch at 1-800-332-1088, and
◦Celgene Corporation at 1-888-423-5436
Pomalyst can pass into human semen:
◦Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking Pomalyst, during any breaks (interruptions) in your treatment with Pomalyst, and for 4 weeks after stopping Pomalyst.
◦Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
◦Do not donate sperm while taking Pomalyst, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping Pomalyst. If a female becomes pregnant with your sperm, the baby may be exposed to Pomalyst and may be born with birth defects.
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