Drugs & Vitamins

Zevalin Active Ingredients: Ibritumomab tiuxetan Representative Names: Zevalin What is ibritumomab tiuxetan injection? What should I tell my health care provider before I take this medicine? How should I use this medicine? What if I miss a dose? What drug(s) may interact with ibritumomab tiuxetan? What side effects may I notice from using ibritumomab tiuxetan? What should I watch for while taking ibritumomab tiuxetan? Where can I keep my medicine? What is ibritumomab tiuxetan injection? (Back to top) IBRITUMOMAB TIUXETAN (Zevalin®) is a protein that targets specific lymphoma cells. To be effective ibritumomab tiuxetan is linked to a radioactive agent called yttrium chloride (Y-90). The medicine allows radiation to be delivered directly to the sites of the lymphoma. Generic ibritumomab tiuxetan injections are not available. 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: •bleeding or blood disorders •difficulty breathing •heart disease or an abnormal heart rhythm •infection (especially virus infections such as chickenpox or herpes) •history of a heart attack or angina (chest pain) •low blood pressure •low platelet counts •lung disease •kidney disease •recent chemotherapy or radiation therapy •an unusual or allergic reaction to ibritumomab, rituximab, abciximab, albumin, mouse proteins, nuclear medicine bone scan drugs, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I use this medicine? (Back to top) The Zevalin® treatment regimen is given by infusion into a vein. The treatment course is divided into in 2 steps given over a period of 7—9 days. The treatment is administered in a hospital or clinic setting by a health care professional. During the first step you will receive rituximab (Rituxan®) and ibritumomab tiuxetan plus indium-111 chloride (In-111 ibritumomab). The In-111 is an imaging agent that allows your prescriber to make sure the ibritumomab goes to the right places in your body. You will have to get special imaging studies done after you receive this dose and before you continue on to the next step. The second step is begun 7—9 days after the first step and consists of another dose of rituximab (Rituxan®) followed by ibritumomab tiuxetan plus yttrium-90 chloride (Y-90 ibritumomab). What if I miss a dose? (Back to top) This does not apply. What drug(s) may interact with ibritumomab tiuxetan? (Back to top) •clopidogrel •dipyridamole •medicines for blood clots, sometimes called 'blood thinners', such as warfarin (Coumadin®) •ticlopidine •vaccines Talk to your prescriber or health care professional before taking any of these over-the-counter medicines: •aspirin •ibuprofen •ketoprofen •naproxen 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 using ibritumomab tiuxetan? (Back to top) The side effects you may experience during the Zevalin™ treatment regimen depend upon the dose, other types of chemotherapy or radiation therapy you have received in the past, and the disease being treated. Not all of these effects occur in all patients. Discuss any concerns or questions with your prescriber or health care professional. Side effects that you should report to your prescriber or health care professional immediately: •difficulty breathing •painful sores in the mouth, eyes, or nose •redness, blistering, peeling, or loosening of the skin, including inside the mouth •skin rash of any type, itching or hives •swelling of the face, lips, or tongue Side effects that you should report to your prescriber or health care professional as soon as possible: •low blood counts: ibritumomab tiuxetan may decrease the number of white blood cells, red blood cells, and platelets. You may be at increased risk for infection and bleeding. •signs of infection: fever or chills, cough, sore throat, pain, or difficulty passing urine •signs of bleeding or decreased platelets: bruising, pinpoint red spots on the skin, black, tarry stools, and blood in the urine •signs of decreased red blood cells: unusual weakness or tiredness, fainting spells, lightheadedness •chills •fever •palpitations •severe dizziness •swelling in the ankles or feet Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •anxiety •back pain •cough •flushing •headache •itching •loss of appetite •dizziness •muscle aches •nausea, vomiting •night sweats •runny nose •stomach pain What should I watch for while taking ibritumomab tiuxetan? (Back to top) You must visit you prescriber or health care professional regularly for periodic blood tests to monitor your condition and the effects of the Zevalin® treatment regimen. The effects of the Zevalin® therapeutic regimen are limited to within your own body. Other people will not be harmed by coming into contact with you. You may eat and drink normally after receiving the Zevalin® treatment regimen. For 3 days after injection of Y-90 ibritumomab, clean up spilled urine and dispose of any material that contains body fluids to prevent exposure to others (e.g., flush it down the toilet or place in a plastic bag in the household trash). Wash hands thoroughly with soap and water after using the toilet. For one week after treatment with Y-90 ibritumomab, use condoms during sexual relations. Y-90 ibritumomab could cause serious birth defects if given to a patient while she is pregnant. Effective contraception (birth control) should be used during Zevalin® treatment and for up to 12 months following completing therapy. There is a potential risk that Y-90 ibritumomab could affect your ability to have children. Discuss your options with your health care provider. The Zevalin® treatment regimen will cause decreases in your platelet and white blood cells. Notify your prescriber or health care professional if you notice increased bruising, bleeding or blood in your urine or stools. Unless instructed to by your prescriber or health care professional, avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), naproxen (Aleve®), or ketoprofen (Orudis® KT) products as these may mask a fever or increase your risk to bleed if you have low white blood cell or platelet counts. You should tell any other health care professional providing you with medical care, including dentists, that you have received the Zevalin® treatment regimen. Where can I keep my medicine? (Back to top) This does not apply. You will not be given injections of this medicine to keep at home. Last Updated:11/08/2005 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.