Warning

WARNING: Lenalidomide is very similar to thalidomide, a drug which has caused severe (possibly fatal) birth defects when used during pregnancy. If lenalidomide is taken during pregnancy, it may also cause severe (possibly fatal) birth defects. Women who are pregnant or who may become pregnant must not use lenalidomide. Women must have two negative pregnancy tests before starting lenalidomide (the first test 10 to 14 days before the first dose and the second test within 24 hours before the first dose). Women must also continue to have pregnancy tests regularly during treatment (every 2 to 4 weeks). Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 4 weeks before starting lenalidomide, during use, and for 4 weeks after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late or if you have irregular bleeding, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor right away. Because lenalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Continue using condoms and other birth control as directed until 4 weeks after lenalidomide treatment has been stopped. You should have a blood test for hepatitis B virus before starting treatment. Some people with this virus may have a serious flare-up when using lenalidomide. To receive this medication, all doctors, pharmacists, and patients must understand, agree to, and carefully follow the requirements of the Revlimid REMS Program created by the U.S. Food and Drug Administration. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. This medication may cause a low number of white blood cells and platelets. Your doctor will monitor you closely while you take this medication and may adjust the dose of the medication or stop the medication based on your lab test results. Get medical help right away if you develop any of the following symptoms: signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough), easy bleeding/bruising. Lenalidomide may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you smoke, or have a history of blood clots, high blood pressure, or high cholesterol, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. To lower your risk, your doctor may prescribe an additional medication. Before using lenalidomide, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if you have any signs of a blood clot, including: shortness of breath, chest/jaw/left arm pain, unusual sweating, confusion, pain/swelling/redness in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.