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VO: REVLIMID® (lenalidomide) may cause serious side effects, including risk to unborn babies, risk of low blood counts and blood clots. There are safety considerations to be aware of with REVLIMID. That is why REVLIMID is only available through a restricted distribution program, Lenalidomide REMS. Please listen for Important Safety Information throughout this video.
VO: Navigating Multiple Myeloma can be complicated…
VO: ... No matter who you are.
VO: Or where you are with your multiple myeloma treatment.
VO: Although every patient's journey is different, knowing about multiple myeloma and where to turn for support may help. By signing up for our My Moments, My Support program you’ll receive information on multiple myeloma and REVLIMID…
VO: …that includes disease information, what to expect from treatment with REVLIMID and how BMS Access Support may be able to help you.
VO: If you start taking REVLIMID you can also opt-in to receive a kit that will help you prepare for doctor visits and organize your treatment plan with your doctor.
VO: The My Moments, My Support program gives you the support that may help you with your multiple myeloma journey.
VO: When it comes to why to join My Moments, My Support, fellow patients say it best.
VO: Get support and information about multiple myeloma and using REVLIMID by joining the My Moments, My Support program today at REVLIMID.com.
Important Safety Information
REVLIMID is a prescription medicine used to treat adults with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells).
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.
WARNING: Risk to unborn babies, risk of low blood counts and blood clots.
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.
Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.
Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine.
Before taking REVLIMID, tell your healthcare provider:
Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID:
Do not take REVLIMID if you:
Before you take REVLIMID, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
Take REVLIMID exactly as prescribed and follow all the instructions of the Lenalidomide REMS program
REVLIMID can cause serious side effects, including:
See “What is the most important information I should know about REVLIMID?”
Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.
Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and certain other types of cancers of the skin and other organs. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID.
Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with REVLIMID. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:
Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:
Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
Worsening of your tumor (tumor flare reaction) can happen with REVLIMID and may cause death. Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender, swollen lymph nodes; low-grade fever, pain, or rash.
Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment with REVLIMID.
These are not all of the possible side effects of REVLIMID. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
REVLIMID® and the REVLIMID logo are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb Company. Access Support® is a registered trademark of Bristol-Myers Squibb Company.
© 2022 Bristol-Myers Squibb Company.