REVLIMID® (lenalidomide) is a prescription medicine used to treat adults with a condition called myelodysplastic syndromes (MDS). REVLIMID is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions. 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.
Serious side effects
These are not all the possible side effects of REVLIMID. Your healthcare provider may adjust your dose or have you temporarily or permanently stop taking REVLIMID if you develop certain serious side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking REVLIMID, talk to your doctor about the serious side effects
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 (THALOMID). 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 Celgene Customer Care 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 that 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.
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 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:
- If you have had a blood clot in the past
- If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)
- About all the medicines you take. Certain other medicines can also increase your risk for blood clots
Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID:
- Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling
- Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting
- Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance
Increased risk of death in people with 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), and 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:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark or brown (tea-colored) urine
- pain on the upper right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
- feeling very tired
Severe skin reactions and severe allergic reactions
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:
- a red, itchy, skin rash
- peeling of your skin or blisters
- severe itching
Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:
- swelling of your lips, mouth, tongue, or throat
- trouble breathing or swallowing
- raised red areas on your skin (hives)
- a very fast heartbeat
- you feel dizzy or faint
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)
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 check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.
Risk of early death in MCL
In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.