See other indications for REVLIMID:
This site is intended for US audiences only.
This site is intended for US audiences only.
REVLIMID is a prescription medicine used to treat people with mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with two prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.
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.
WHAT IS THE LENALIDOMIDE REMS PROGRAM?
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.
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.
HOW DO I RECEIVE MY FIRST PRESCRIPTION?*
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
You and your healthcare provider will then complete and submit the REVLIMID® (lenalidomide) Patient-Physician Agreement Form
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
Your healthcare provider will send your prescription to a specialty pharmacy
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
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 subsequent REVLIMID 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.
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
If you can get pregnant, you must take an initial pregnancy test within 10-14 days before getting a REVLIMID prescription
If you can get pregnant, you must take a second pregnancy test within 24 hours before getting a REVLIMID prescription
You and your healthcare provider will then complete and submit the REVLIMID® (lenalidomide) Patient-Physician Agreement Form
You and your healthcare provider will each complete a survey. Visit www.LenalidomideREMS.com or call
Your healthcare provider will send your prescription to a specialty pharmacy
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
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 subsequent REVLIMID 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.
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:
Females who can become pregnant:
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:
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:
Men: If your female partner becomes pregnant, you should call your healthcare provider right away.
*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 Lenalidomide REMS or review the Patient Guide to the Lenalidomide REMS program.