hocytic 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 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.
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
Serious allergic reactions and serious skin 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 serious allergic reaction or serious skin reaction during treatment with REVLIMID: swelling of your face, eyes, lips, tongue, throat
trouble swallowing
trouble breathing
skin rash, hives, or peeling of your skin
blisters
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 tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment with REVLIMID.
Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.
The most common side effects of REVLIMID include:
diarrhea
rash
nausea
constipation
tiredness
fever
itching
swelling of the limbs and skin
cough
These are not all 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.
How should I store REVLIMID?
Store REVLIMID at room temperature between 68°F to 77°F (20°C to 25°C).
Return any unused REVLIMID to Celgene or your healthcare provider.
Keep REVLIMID and all medicines out of the reach of children.
General information about the safe and effective use of REVLIMID Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take REVLIMID for conditions for which it was
