Drugs & Vitamins

Gemtuzumab ozogamicin Active Ingredients: Gemtuzumab ozogamicin Representative Names: Mylotarg What is gemtuzumab ozogamicin injection do? 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 gemtuzumab ozogamicin? What side effects may I notice from receiving gemtuzumab ozogamicin? What should I watch for while taking gemtuzumab ozogamicin? Where can I keep my medicine? What is gemtuzumab ozogamicin injection do? (Back to top) GEMTUZUMAB OZOGAMICIN (Mylotarg™) is chemotherapy agent used for treating acute myelogenous leukemia (AML). Gemtuzumab ozogamicin is a special kind of drug (a monoclonal antibody) that targets the leukemia cells. Unfortunately, it also affects some good cells, which leads to some side effects. Generic gemtuzumab ozogamicin 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: •difficulty breathing or any lung condition •bleeding problems •dental disease •infection (especially cold sores or shingles) •jaundice •liver disease •previous bone marrow or stem cell transplant •an unusual or allergic reaction to gemtuzumab ozogamicin, mouse proteins, other chemotherapy, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I use this medicine? (Back to top) Gemtuzumab ozogamicin is infused into a vein by a specially trained health care provider. It is usually administered in a hospital or clinic setting. You will receive medication (acetaminophen, Tylenol®, and diphenhydramine, Benadryl®) before your infusion to help decrease side effects related to the infusion. You will be closely monitored during and after the infusion for side effects. 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 gemtuzumab ozogamicin? (Back to top) •vaccines Talk to your prescriber or health care professional before taking any of these medicines: •aspirin •acetaminophen •ibuprofen •ketoprofen •naproxen Tell your prescriber or health care professional about all other medicines that 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 gemtuzumab ozogamicin? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: During and up to 4 hours after the infusion: •chills •difficulty breathing, wheezing •dizziness •headache •nausea/vomiting •shortness of breath After the infusion of gemtuzumab ozogamicin: •difficulty passing urine •mouth or throat sores or ulcers •low blood counts - gemtuzumab ozogamicin 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 infection - fever or chills, cough, sore throat, pain or difficulty passing urine •signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine •signs of decreased red blood cells - unusual weakness or tiredness, fainting spells, lightheadedness •stomach pain Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •back pain •constipation •diarrhea •difficulty sleeping •heartburn •muscle or joint aches and pains What should I watch for while taking gemtuzumab ozogamicin? (Back to top) Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood checks. The side effects of gemtuzumab ozogamicin may continue after you finish your treatment; report side effects promptly. Gemtuzumab ozogamicin may make you feel generally unwell. This is not uncommon because gemtuzumab ozogamicin affects good cells as well as cancer cells. Gemtuzumab ozogamicin will 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 or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Gemtuzumab ozogamicin 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. Avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), ketoprofen (Orudis KT®) or naproxen (Aleve®) products as these may mask a fever, unless instructed to by your prescriber or health care professional. Be careful brushing and flossing your teeth or using a toothpick while receiving gemtuzumab ozogamicin because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are taking gemtuzumab ozogamicin. Do not have any vaccinations without your prescriber's approval and avoid anyone who has recently had the oral polio vaccine. Women of childbearing age should use effective birth control methods during and after gemtuzumab ozogamicin treatment. There is a risk of birth defects if gemtuzumab ozogamicin is given during pregnancy. Women should not become pregnant while being treated with gemtuzumab ozogamicin. Drink several glasses of water a day. This will help to reduce the risk of possible kidney problems. Where can I keep my medicine? (Back to top) Gemtuzumab ozogamicin injection will be given to you in a hospital or clinic setting. You will not take this medicine at home. Last Updated:05/18/2001 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.