Getting started with the
Lenalidomide REMS program

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 which is known to 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:

• Must 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 2 different forms of effective 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 effective 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 the REMS Call 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, 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 Celgene Corporation, a Bristol-Myers Squibb Company, at the phone number listed above.

REVLIMID can pass into human semen:

• Males, including those who have had a vasectomy, must always 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 up to 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 up to 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.