Drugs & Vitamins

Lenalidomide capsules Active Ingredients: Lenalidomide capsules Representative Names: Revlimid What are Lenalidomide capsules? What should I tell my health care provider before I take this medicine? How should this medicine be used? What if I miss a dose? What drug(s) may interact with Lenalidomide? What side effects may I notice from receiving Lenalidomide? What should I watch for while taking Lenalidomide? Where can I keep my medicine? What are Lenalidomide capsules? (Back to top) LENALIDOMIDE (Revlimid®) treats a form of myelodysplastic syndromes. The medicine may help you not need blood transfusions. To get lenalidomide, you must be registered in the RevAssist™ program. Your healthcare provider will explain the program to you and have you sign an agreement form. You will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill. Your prescription must be filled within 7 days of your doctor's office visit. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •blood clots in the legs or the lungs •infection •irregular monthly periods or menstrual cycles •kidney disease •an unusual reaction to lenalidomide, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should this medicine be used? (Back to top) Take this medicine by mouth. Swallow the capsules with a full glass of water. Do not break, chew, or open your capsules. Follow the directions on the prescription label. Do not take more medicine than you are told to take. Do not share this medicine with anyone else. A MedGuide will be given with each prescription and refill. Read this guide carefully each time. The MedGuide may change frequently. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose, take it as soon as you can. If you miss taking your dose for the entire day, go back to taking your regular dose the next day. Do not take double or extra doses. What drug(s) may interact with Lenalidomide? (Back to top) Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from receiving Lenalidomide? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •arm or leg swelling •chest pain •fever •pain in the legs •signs or symptoms of an infection like a cough, running nose, or sore throat •signs or symptoms of bleeding like unusual bruising, nosebleeds, bleeding gums, blood in the urine or stool, or coughing up blood •trouble breathing Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •diarrhea •itching •rash •tiredness What should I watch for while taking Lenalidomide? (Back to top) Lenalidomide can cause birth defects. Do not get pregnant while taking this drug. •All females who may be able to have children: You will get information about the risks of taking lenalidomide. It is very important for you to read and understand all of the information given to you. You must sign a consent form and review materials that describe the precautions you must take. If you do not understand any part of the consent forms, do not sign them, and do not take any lenalidomide until all of your questions have been answered. If you do not have the Medication Guide, do not start taking lenalidomide. Call your doctor. You will need to have 2 negative pregnancy tests before starting lenalidomide and then monthly pregnancy tests during treatment, even if you are not sexually active. You cannot get monthly refills for lenalidomide unless there is proof of the negative pregnancy test. Use 2 reliable forms of birth control together for 1 month before starting, during, and for 1 month after stopping lenalidomide therapy. If you become pregnant, miss a menstrual cycle, or stop using birth control, you must immediately stop taking lenalidomide. Immediately call your doctor if you think you may be pregnant. Severe birth defects may occur even if just one dose of lenalidomide is taken. Do not breast-feed your baby while taking lenalidomide or for 1 month after stopping treatment. •All Males: You will get information about the risks of taking lenalidomide. You should read the Medication guide and review all other information supplied. You will need to sign a consent form that indicates you understand the information and instructions. During sexual contact with a woman, you must use a latex condom while taking lenalidomide and for 30 days after you stop taking lenalidomide. A latex condom is needed even if you have had a vasectomy. Immediately call your doctor if your partner becomes pregnant. Do not donate sperm while taking lenalidomide and for 30 days after you stop taking lenalidomide to avoid exposing pregnant women to lenalidomide through the donated sperm. Do not give blood while taking the medicine and for 30 days after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood. Do not share this medicine with anyone else due to the risk of birth defects and other serious side effects. You will have your blood checked every week during the first 2 months you take lenalidomide. Your blood will then be checked at least monthly while you take the medicine. You can get information about the drug by calling the toll-free number 1—888—423—5436. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date. Last Updated:06/11/2006 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.