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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. Keep 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 lenalidomide in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. 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 serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). 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 any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

Diarrhea, stomach/abdominal pain, nausea/vomiting, loss of appetite, constipation, dizziness, dry skin, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression), increased thirst/urination, shaking (tremor), numbness/tingling of arms/legs, fast/slow/irregular heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Some people treated with this medication may rarely get other cancers. Consult your doctor for more details. Lenalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness. People taking lenalidomide may have worsening of their symptoms (tumor flare reaction). If you have tender/swollen lymph nodes, fever, pain, or rash, contact your doctor right away. This drug helps many people live longer. However, some people who have used lenalidomide have died sooner than expected, especially if they had high white blood cell or tumor cell counts. Talk with your doctor about the risks and benefits of using this medication. Lenalidomide may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. Lenalidomide can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.