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Generic Name: Gemtuzumab Ozogamicin (gem-TOO-zoo-mab oh-zoh-ga-MYE-sin)
Brand Name: Mylotarg

Mylotarg should not be used along with other chemotherapy medicines. Severe bone marrow problems occur even at normal doses of Mylotarg . Severe and sometimes fatal allergic reactions and lung problems have occurred with use of Mylotarg . Tell the doctor immediately if you experience rash; hives; difficulty breathing; swelling of the mouth, face, lips, or tongue; or severe dizziness. Mylotarg may also increase the risk of severe and sometimes fatal liver problems. This risk may be increased if you have liver problems, you have had a hematopoietic stem-cell transplant (HSCT), or you use Mylotarg in combination with other chemotherapy medicines. Contact your doctor immediately if you experience sudden weight gain, right-sided stomach pain, stomach swelling, yellowing of the eyes or skin, or dark urine. Your doctor will monitor you closely while you use Mylotarg .

Mylotarg is used for:

Treating acute myeloid leukemia (AML) in patients 60 years of age and older who cannot take other cancer medications. It may also be used for other conditions as determined by your doctor.

Mylotarg is a chemotherapy agent. It works by binding to and breaking specific parts that the cancer cell needs to survive.

Do NOT use Mylotarg if:

  • you are allergic to any ingredient in Mylotarg

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mylotarg :

Some medical conditions may interact with Mylotarg . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems or lung disease

Some MEDICINES MAY INTERACT with Mylotarg . However, no specific interactions with Mylotarg are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mylotarg may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mylotarg :

Use Mylotarg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Mylotarg is usually administered as an infusion at your doctor"s office, hospital, or clinic. If you are using Mylotarg at home, carefully follow the infusion procedures taught to you by your health care provider.
  • You may need to take certain other medicines (eg, acetaminophen, diphenhydramine) before using Mylotarg in order to help decrease the risk of certain side effects that may occur while using Mylotarg . Discuss any questions or concerns with your doctor.
  • If Mylotarg contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Mylotarg , or your dose is interrupted, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Mylotarg .

Important safety information:

  • This medicine may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mylotarg . Using Mylotarg alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Mylotarg may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • Mylotarg may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
  • LAB TESTS, including liver function tests, complete blood cell counts, platelet counts, and electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Mylotarg with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Mylotarg may cause harm to the fetus. Avoid becoming pregnant while you are using Mylotarg . If you think you may become pregnant, discuss with your doctor the benefits and risks of using Mylotarg during pregnancy. It is unknown if Mylotarg is excreted in breast milk. Do not breast-feed while taking Mylotarg .

Possible side effects of Mylotarg :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; cough; diarrhea; dizziness; fatigue; headache; indigestion; joint pain; loss of appetite; mouth sores; nausea; pain or inflammation at the injection site; runny nose; sleeplessness; stomach pain; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in amount or frequency of urine; chest pain; dark urine; depression; fast or irregular heart rate; fever, chills, or sore throat; increased thirst; one-sided weakness; pink or red-colored urine; right-sided stomach pain; seizure; severe dizziness; severe headache; shortness of breath; slurred speech; stomach swelling; sudden weight gain; swelling of the arms, legs, or feet; unusual bleeding or bruising (eg, nosebleed, red or purple spots under the skin, unusual vaginal bleeding); vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (, or emergency room immediately.

Proper storage of Mylotarg :

Mylotarg is usually handled and stored by a health care provider. If you are using Mylotarg at home, store Mylotarg as directed by your pharmacist or health care provider.

General information:

  • If you have any questions about Mylotarg , please talk with your doctor, pharmacist, or other health care provider.
  • Mylotarg is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mylotarg . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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