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Gemtuzumab ozogamicin

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

Gemtuzumab ozogamicin should not be used along with other chemotherapy medicines. Severe bone marrow problems occur even at normal doses of gemtuzumab ozogamicin. Severe and sometimes fatal allergic reactions and lung problems have occurred with use of gemtuzumab ozogamicin. Tell the doctor immediately if you experience rash; hives; difficulty breathing; swelling of the mouth, face, lips, or tongue; or severe dizziness. Gemtuzumab ozogamicin 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 gemtuzumab ozogamicin 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 gemtuzumab ozogamicin.


Gemtuzumab ozogamicin 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.

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

Do NOT use gemtuzumab ozogamicin if:

  • you are allergic to any ingredient in gemtuzumab ozogamicin

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

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Before using gemtuzumab ozogamicin:

Some medical conditions may interact with gemtuzumab ozogamicin. 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 gemtuzumab ozogamicin. However, no specific interactions with gemtuzumab ozogamicin are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if gemtuzumab ozogamicin 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 gemtuzumab ozogamicin:

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

  • Gemtuzumab ozogamicin is usually administered as an infusion at your doctor's office, hospital, or clinic. If you are using gemtuzumab ozogamicin 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 gemtuzumab ozogamicin in order to help decrease the risk of certain side effects that may occur while using gemtuzumab ozogamicin. Discuss any questions or concerns with your doctor.
  • If gemtuzumab ozogamicin 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 gemtuzumab ozogamicin, or your dose is interrupted, contact your doctor immediately.

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

Important safety information:

  • Gemtuzumab ozogamicin may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to gemtuzumab ozogamicin. Using gemtuzumab ozogamicin alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Gemtuzumab ozogamicin 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.
  • Gemtuzumab ozogamicin 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 gemtuzumab ozogamicin with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Gemtuzumab ozogamicin may cause harm to the fetus. Avoid becoming pregnant while you are using gemtuzumab ozogamicin. If you think you may become pregnant, discuss with your doctor the benefits and risks of using gemtuzumab ozogamicin during pregnancy. It is unknown if gemtuzumab ozogamicin is excreted in breast milk. Do not breast-feed while taking gemtuzumab ozogamicin.

Possible side effects of gemtuzumab ozogamicin:

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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 gemtuzumab ozogamicin:

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

General information:

  • If you have any questions about gemtuzumab ozogamicin, please talk with your doctor, pharmacist, or other health care provider.
  • Gemtuzumab ozogamicin 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about gemtuzumab ozogamicin. 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: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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