Getting started with
Lenalidomide REMS

WHAT IS LENALIDOMIDE REMS?

To avoid serious risks to unborn babies, REVLIMID is only available through a restricted distribution program called Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.

You must be enrolled in the Lenalidomide REMS program before your doctor can prescribe REVLIMID. There are special requirements for men and women in the program.

Your doctor will tell you how to take REVLIMID. 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 REVLIMID?

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing REVLIMID, your healthcare provider will explain the Lenalidomide 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. 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 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, a Bristol Myers Squibb company, 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 pregnancy. You can enroll in this registry by calling Bristol Myers Squibb at the phone number listed above.

REVLIMID 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 REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID.
• 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 REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.