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)
• 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.
• mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 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.
• follicular lymphoma (FL) or marginal zone lymphoma (MZL) -- in combination with a rituximab product, and -- who have previously been treated for their FL or MZL
FL and MZL are types of cancer of white blood cells called B-cell lymphocytes that are found in the lymph nodes and spleen. 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.
• are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. • are allergic to lenalidomide or any of the ingredients in REVLIMID.
Before you take REVLIMID, tell your healthcare provider about all of your medical conditions, including if you:
• have liver problems • have kidney problems or receive kidney dialysis treatment • have thyroid problems • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID. • are lactose intolerant. REVLIMID contains lactose. • are breastfeeding. Do not breastfeed during treatment with REVLIMID. It is not known if REVLIMID passes into your breast milk and can harm your baby.
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.
• Do not open or break REVLIMID capsules or handle them any more than needed. -- If powder from the REVLIMID capsule comes in contact with your skin, wash the skin right away with soap and water. -- If powder from the REVLIMID capsule comes in contact with the inside of your eyes, nose, or mouth, flush well with water.
• If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
• If you take too much REVLIMID, call your healthcare provider right away.
• Females: Do not get pregnant and do not breastfeed while taking REVLIMID. • Males: Do not donate sperm. • Do not share REVLIMID with other people. It may cause birth defects and other serious problems. • Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.
• 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), 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
• 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 • fever
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 tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects 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.
• 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 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.