About the POMALYST REMS® safety program
To avoid serious risks to unborn babies, POMALYST is only available through a restricted distribution program called POMALYST Risk Evaluation and Mitigation Strategy (REMS®) program.
Before you’re prescribed POMALYST, you must be enrolled in the POMALYST REMS® program. There are special requirements for men and women in the program.
Your doctor will tell you how to take POMALYST. Follow your doctor’s instructions carefully. Be sure to talk with your doctor or nurse if you have questions.
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. We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. 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
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 POMALYST.
- 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 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 1-888-423-5436 for medical information. Healthcare providers and patients should report all cases of pregnancy to:
- FDA MedWatch at 1-800-FDA-1088
- 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 who 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
Men, if your female partner becomes pregnant, you should call your healthcare provider right away.
Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.