Mylotarg (gemtuzumab ozogamicin) is a brand-name drug that’s prescribed to treat certain types of acute myeloid leukemia in adults and some children. Mylotarg is given by intravenous infusion by a healthcare professional.

Mylotarg is approved by the Food and Drug Administration (FDA) to treat CD33-positive acute myeloid leukemia (AML) that’s newly diagnosed, has come back after remission, or when other treatments haven’t worked.

Mylotarg is a biologic and belongs to a drug class called monoclonal antibodies. Mylotarg isn’t available in a biosimilar version.

Keep reading for specific information about the dosage of Mylotarg, including its strength and how the medication is used. For a comprehensive look at Mylotarg, see this article.

Note: This article describes typical dosages for Mylotarg provided by the drug’s manufacturer. However, your doctor will prescribe the Mylotarg dosage that’s right for you.

Read below for details about Mylotarg’s dosages for its approved uses.

Mylotarg form

Mylotarg comes as a powder in a single-dose vial. The powder is mixed with a liquid to form a solution for intravenous (IV) infusion. You’ll receive the IV infusion in a hospital or clinic.

Mylotarg strength

Mylotarg comes in one strength: 4.5 milligrams (mg) per single-dose vial.

Typical dosages

The following information describes dosages that are commonly used or recommended.Your doctor will determine the best dosage to fit your needs.

Dosage for acute myeloid leukemia

The dose of Mylotarg your doctor prescribes will depend on which form of AML it’s being used to treat. Your dose will also depend on whether Mylotarg is being used alone or with chemotherapy. The typical dosages recommended for adults are described below.

For newly diagnosed AML, when used with chemotherapy: The recommended dose of Mylotarg when used with chemotherapy is 3 milligrams per square meter (mg per m2 ) of body surface area, up to 4.5 mg (one vial) per dose. One treatment course includes one induction cycle and two consolidation cycles:

  • Induction cycle: Mylotarg is typically given on days 1, 4, and 7 of your first week of treatment. You’ll likely receive chemotherapy every day this week.
  • Consolidation cycle: You’ll likely receive a Mylotarg infusion on day 1 and chemotherapy on days 1–4.

For newly diagnosed AML, when used alone: When Mylotarg is used alone, treatment includes one induction cycle and up to eight consolidation cycles.

  • Induction cycle: The recommended dose of Mylotarg is 6 mg per m2 of body surface area given on day 1 of treatment. A dose of 3 mg per m2 of body surface area is given on day 8 of treatment.
  • Continuation cycles: The recommended dose for each continuation cycle is 2 mg per m2 of body surface. These doses are usually given once every 4 weeks.

For relapsed or refractory AML: Mylotarg is used alone for this purpose. The recommended dose is 3 mg per m2 of body surface area, up to 4.5 mg (one vial) per dose. It’s typically given as one round of treatment on days 1, 4, and 7.

For more information about your specific dosage, talk with your doctor.

Children’s dosage

Mylotarg is approved to treat newly diagnosed AML in children ages 1 month and older. It’s also used for relapsed or refractory AML in children ages 2 years and older.

The dose of Mylotarg is based on the child’s body surface area. The recommended dosages for children are described below.

For newly diagnosed AML: Mylotarg is used with chemotherapy for newly diagnosed AML. Your child will likely have five rounds of chemotherapy. Mylotarg is typically given on day 6 of the first round and on day 7 of the fourth round. The dose depends on your child’s body surface area and will be calculated by your child’s doctor.

  • For children with a body surface area of less than 0.6 m2: The recommended dose is 0.1 mg per kilogram (kg) of body weight. One kg equals about 2.2 pounds (lb).
  • For children with a body surface area of 0.6 m2 or more: The recommended dose is 3 mg per m2 of body surface area.

For relapsed or refractory AML: Mylotarg is used alone for this purpose. The recommended dose is 3 mg per m2 of body surface area, up to 4.5 mg (one vial) per dose. It’s typically given as one round of treatment on days 1, 4, and 7.

Talk with your child’s doctor if you have questions about their dosage.

Long-term treatment

Mylotarg is used in the short term to treat AML. The dosage your doctor prescribes for you will depend on a number of factors, including the type of AML you have, how your body responds to treatment, and what types of side effects you may have.

Talk with your doctor if you have questions about how long you can expect treatment with Mylotarg to last.

The Mylotarg dosage your doctor prescribes will depend on several factors. These include:

  • your age
  • your body surface area (measured in square meters [m2])
  • the type of AML Mylotarg is being used to treat
  • how your body responds to treatment with Mylotarg
  • other treatments used with Mylotarg
  • side effects you may have with Mylotarg

Your doctor or another healthcare professional will give you the IV infusion of Mylotarg. An infusion is an injection that’s given directly into your vein over a period of time.

A healthcare professional will mix the powder form of Mylotarg with a liquid to make a solution. Then, they’ll prepare the solution for your infusion, which is typically given at your doctor’s office, an infusion center, or a hospital. The infusion takes about 2 hours. Your doctor will likely give you medications, including acetaminophen (Tylenol), diphenhydramine, and methylprednisolone, about 1 hour before your infusion to help prevent side effects.

If you miss your appointment for a Mylotarg infusion, call your doctor’s office as soon as possible to reschedule. They’ll adjust your dosing schedule as needed.

If you need help remembering your appointments, try setting an alarm or downloading a reminder app on your phone.

Below are some frequently asked questions about Mylotarg.

How long does it take for Mylotarg to start working?

Mylotarg starts to work after your first dose. Because of how the drug works, you likely won’t feel the drug working in your body. But your doctor will monitor you during treatment to check whether the drug is working to treat your condition.

Talk with your doctor if you have questions about what to expect with Mylotarg treatment.

What is the recommended maximum dosage of Mylotarg?

The maximum recommended dosage of Mylotarg will depend on what type of AML is being treated and your body’s surface area.

  • For newly diagnosed AML, when used with chemotherapy: The maximum dose is one 4.5-mg vial for each infusion.
  • For newly diagnosed AML, when used alone: Your dose will be based on your body surface area and will be calculated by your doctor. Your dose may require more than one vial.
  • For relapsed or refractory AML: The maximum dose is one 4.5-mg vial for each infusion.

For more information about Mylotarg dosages, see the “Mylotarg dosage” section above. If you have questions or concerns about your dosage of Mylotarg, talk with your doctor.

The dosages in this article are typical dosages provided by the drug’s manufacturer. If your doctor recommends Mylotarg for you, they’ll prescribe the dosage that’s right for you. If you have questions about the dosage of Mylotarg that’s best for you, talk with your doctor.

Besides learning about dosage, you may want other information about Mylotarg. These additional articles might be helpful:

  • More about Mylotarg: For information about other aspects of Mylotarg, refer to this article.
  • Side effects: To learn about the side effects of Mylotarg, see this article. You can also look at the Mylotarg prescribing information.
  • Details about your condition: For details about leukemia, see our leukemia hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.