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Overview: Mylotarg is commonly used for acute myeloid leukemia (AML) in certain people. Common side effects include bleeding, infection, fever, stomach problems, changes in labs, rash, mouth or lip sores, and decreased appetite. Call your health care provider right away if you have fever, low blood pressure, yellowing of your skin or the whites of your eyes, or changes in heart rate or rhythm.

Uses

What is Mylotarg used for?

Mylotarg (gemtuzumab ozogamicin) is commonly used for acute myeloid leukemia (AML) in certain people.

Mylotarg may also be used for other conditions as determined by your health care provider.

How does Mylotarg work (mechanism of action)?

Mylotarg is an antibody drug conjugate that works by targeting a specific protein that is on the surface of some cancer cells. It then attaches itself to this protein and delivers a chemotherapy medicine into the cell that kills the cancer cell.

How is Mylotarg supplied (dosage forms)?

Brands and other names

  • Mylotarg

Dosage forms and strengths

Mylotarg is available in an injectable form that is given by a health care provider.

How should I store Mylotarg?

Mylotarg is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Mylotarg?

The most common side effects of Mylotarg are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Bleeding (see below)
  • Infection
  • Fever
  • Nausea and vomiting
  • Constipation
  • Headache
  • Changes in liver function tests
  • Rash
  • Mouth or lip sores
  • Low levels of a type of white blood cell (neutrophils)
  • Decreased appetite

There may be other side effects of Mylotarg that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Mylotarg?

While less common, the most serious side effects of Mylotarg are described below, along with what to do if they happen.

Severe Allergic Reactions. Mylotarg may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage and Blood Flow Problems. Liver damage, also called hepatotoxicity, can happen when using Mylotarg. Mylotarg can also cause a condition where the small blood vessels in your liver become blocked, which can damage the liver. Call your health care provider right away if you have any of the following symptoms of liver damage or blood flow problems.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Weight gain
  • Swelling of the stomach area

Infusion Reactions. Mylotarg can cause reactions that can be serious when it is given to you. These reactions may happen while you receive Mylotarg or up to 24 hours afterward. Tell your health care provider right away if you have any of the following symptoms when you get your infusion or shortly after your infusion.

  • Fever or chills
  • Low blood pressure
  • Fast heartbeat
  • Breathing problems

Severe Bleeding. Mylotarg can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while using Mylotarg. 

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots

Heart Rhythm Changes. Mylotarg may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Warnings & Precautions

Who should not use Mylotarg?

Allergies to Ingredients. People who are allergic to any of the following should not use Mylotarg.

  • Gemtuzumab
  • Gemtuzumab ozogamicin
  • Mylotarg
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Mylotarg.

What should I know about Mylotarg before using it?

Mylotarg is usually given by a health care provider in a hospital or clinic.

Keep all appointments to have your blood tests checked.

Mylotarg may make it hard for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

Females of childbearing age should use effective birth control to avoid becoming pregnant while receiving Mylotarg and for six months after the last dose. Males with female partners of childbearing age should use effective birth control while receiving Mylotarg and for three months after the last dose to avoid getting their partner pregnant. Talk to your health care provider if you have any questions about birth control.

What should I tell my health care provider before using Mylotarg?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Mylotarg is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Mylotarg may interact with other medicines and supplements. Before using Mylotarg, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Vaccines. Talk to your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Mylotarg. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. Mylotarg may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Mylotarg passes into breast milk. You should not breastfeed while receiving Mylotarg and for one month after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Mylotarg?

For more information about Mylotarg, you can visit the drugmaker’s website at www.pfizermedicalinformation.com/patient/mylotarg or call them at 800-438-1985.

Interactions

Does Mylotarg interact with foods or drinks?

There are no known interactions between Mylotarg and foods or drinks.

There are no known interactions between Mylotarg and alcohol, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. 

Does Mylotarg interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Mylotarg may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Mylotarg?

If you or someone else has used too much Mylotarg, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Mylotarg?

Mylotarg is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Mylotarg as scheduled.

If you miss an appointment to get your Mylotarg dose, call to make another appointment as soon as possible.