These are not all of 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.
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.
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:
Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID:
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.
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 syndrome (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.
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 these signs or symptoms of a severe allergic reaction or severe skin reaction during treatment with REVLIMID:
Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:
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 check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.
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.
The most common side effects of REVLIMID include: diarrhea, rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of a cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, pain in your back or stomach area (abdomen).
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.