Drugs & Vitamins

ONTAK Active Ingredients: Denileukin Deftitox Injection Representative Names: ONTAK What is denileukin diftitox 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 denileukin diftitox? What side effects may I notice from receiving denileukin diftitox? What should I watch for while taking denileukin diftitox? Where can I keep my medicine? What is denileukin diftitox injection? (Back to top) DENILEUKIN DIFTITOX (Ontak™) is medicine used to treat psoriasis and certain kinds of lymphomas including cutaneous T-cell lymphoma, mycosis fungoides, non-Hodgkin's lymphoma. Denileukin diftitox is made to attack certain types of cells related to these diseases. Generic denileukin diftitox 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: •fever or infection •heart disease •coronary artery disease •peripheral vascular disease •an unusual or allergic reaction to denileukin diftitox, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I use this medicine? (Back to top) Denileukin diftitox is usually given as an infusion into a vein every day for 5 days every 3 weeks. Your treatment regimen may be different depending on the condition being treated. Denileukin diftitox is given in a hospital or clinic setting by a health care professional. What if I miss a dose? (Back to top) It is important not to miss your dose. Notify your prescriber or health care professional if you are unable to keep an appointment. What drug(s) may interact with denileukin diftitox? (Back to top) •No drugs are known to interact with denileukin diftitox. Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription 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 denileukin diftitox? (Back to top) 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 as soon as possible: Rare or uncommon: •low blood counts - denileukin diftitox may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding. •signs of decreased platelets - bruising, pinpoint red spots on the skin, increased bleeding •signs of decreased red blood cells - unusual weakness or tiredness •blood clots in your legs More common: •any type of new rash •allergic reactions - shortness of breath, low blood pressure •back pain •change in vision •dehydration •fluid retention •hives •signs of infection - fever or chills, sore throat, cough, runny nose Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •change in weight •constipation •diarrhea •dizziness, nervousness, confusion •headache •heart burn •insomnia •loss of appetite •muscle, bone or joint pain •nausea and vomiting •pain, swelling, or inflammation at the injection site •sweating What should I watch for while taking denileukin diftitox? (Back to top) Denileukin diftitox may make you feel like you have the flu. This is not uncommon. Report any side effects as above, but continue your course of medicine even though you feel ill, unless your prescriber or health care professional tells you to stop. The side effects of denileukin may continue even after you stop therapy. You will need to have blood draws to check on your treatment. During treatment with denileukin diftitox you may have an allergic reaction. If an allergic reaction occurs, it usually will happen on the first day that you receive your infusion each cycle. Tell your prescriber or health care professional if you have any signs of an allergic reaction. Denileukin diftitox causes a syndrome called vascular leak syndrome. This causes more fluids to go out into your tissues. Call your health care professional or prescriber if you notice any increased fluid retention (fingers, legs), or if you have dizziness or fainting. Dizziness may be more common when standing. Denileukin diftitox may decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat or other symptoms of a cold. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Rarely, denileukin diftitox may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bleeding. Be careful not to cut, bruise or injure yourself because you may get an infection and bleed more than usual. Denileukin diftitox may cause diarrhea that begins after treatment. It may last a long time. Call your prescriber or health care professional if you have diarrhea for more than 3 days or are unable to take food or fluids. Where can I keep my medicine? (Back to top) You will only receive this medicine in a clinic or hospital setting. Last Updated:03/18/2006 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.