This site is intended for US audiences only.

This site is intended for US audiences only.

REVLIMID is a prescription medicine used to treat adults with follicular lymphoma (FL) or marginal zone lymphoma (MZL) in combination with a rituximab product, and who have previously been treated for their FL or MZL. FL and MZL are types of cancer of white blood cells called B-cell lymphocytes that are found in the lymph nodes and spleen. REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children.

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Getting started with the
Lenalidomide REMS program

The Lenalidomide REMS program is the first step
to beginning treatment

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

Before you are prescribed REVLIMID, you must be enrolled in the Lenalidomide REMS program. 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.

COUNSELING

Your healthcare provider will counsel you on why and how you and your partner should prevent pregnancy. Your healthcare provider will also inform you not to share the drug, not to donate blood or sperm, and about appropriate contraceptive use. You should be instructed not to extensively handle or open REVLIMID® (lenalidomide) capsules

ENROLLMENT

You and your healthcare provider will then complete and submit the REVLIMID® (lenalidomide) Patient-Physician Agreement Form

COMPLETE MANDATORY CONFIDENTIAL SURVEY

You will not have to take a survey for your first prescription, but will have to for the following ones. Visit www.LenalidomideREMS.com or call 1-8​88-4​23-5​436 and press 1 to take your survey

PRESCRIPTION

Your healthcare provider will send your prescription to a certified pharmacy

PHARMACY CALL

The specialty pharmacy will contact you to provide counseling on the serious risks and safe-use conditions of REVLIMID before you receive your prescription. They will also coordinate delivery of REVLIMID to you

RECEIVE REVLIMID

REVLIMID will be shipped with a Medication Guide to the address you provide. A signature will be required to receive this shipment

For each of your following prescriptions, you will need to follow a similar process. For full detailed information about the Lenalidomide REMS program requirements, please visit www.LenalidomideREMS.com or review the Patient Guide to the Lenalidomide REMS program.

COUNSELING

Your healthcare provider will counsel you on why and how you and your partner should prevent pregnancy. Your healthcare provider will also inform you not to share the drug, not to donate blood, and about appropriate contraceptive use. You should be instructed not to extensively handle or open REVLIMID® (lenalidomide) capsules

PREGNANCY TEST #1

If you can get pregnant, you must take an initial pregnancy test within 10-14 days before getting a REVLIMID prescription

PREGNANCY TEST #2

If you can get pregnant, you must take a second pregnancy test within 24 hours before getting a REVLIMID prescription

ENROLLMENT

You and your healthcare provider will then complete and submit the REVLIMID® (lenalidomide) Patient-Physician Agreement Form

COMPLETE MANDATORY CONFIDENTIAL SURVEY

You and your healthcare provider will each complete a survey. Visit www.LenalidomideREMS.com or call 1-8​88-4​23-5​436 and press 1 to take your survey

PRESCRIPTION

Your healthcare provider will send your prescription to a certified pharmacy

PHARMACY CALL

The specialty pharmacy will contact you to provide counseling on the serious risks and safe-use conditions of REVLIMID before you receive your prescription. They will also coordinate delivery of REVLIMID to you

RECEIVE REVLIMID

REVLIMID will be shipped with a Medication Guide to the address you provide. A signature will be required to receive this shipment

For each of your following prescriptions, you will need to follow a similar process. For full detailed information about the Lenalidomide REMS program requirements, please visit www.LenalidomideREMS.com or review the Patient Guide to the Lenalidomide REMS program.

For more information on Lenalidomide REMS, please visit www.LenalidomideREMS.com.

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 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.