Mylotarg

Mylotarg is a prescription medication used to treat acute myeloid leukemia (AML) that has not responded to previous treatment in patients 2 years and older. It can also be used for newly diagnosed AML in adults.

Mylotarg belongs to a group of drugs called monoclonal antibodies. These work by finding cancer cells and killing them.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Mylotarg include loss of blood, infection, and nausea.

Mylotarg is a prescription medication used to treat leukemia of the white blood cells called acute myeloid leukemia (AML) that has an identification marker on it called CD33. It can be used for CD33 positive AML that:

• has not responded to previous treatment in patients 2 years and older. 
• has come back after previous treatment worked in patients 2 years and older.
• is newly diagnosed in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mylotarg. See the “Mylotarg Precautions” section.

Common side effects of Mylotarg include the following:

• Loss of blood
• Infection
• Fever
• Nausea
• Vomiting
• Constipation
• Headache
• Liver damage
• Rash

This is not a complete list of Mylotarg side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Serious side effects have been reported with Mylotarg including the following:

• infusion related reactions. Symptoms of a reaction due to the injection of Mylotarg into the veins include flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, fast heart rate, itching, rash, fainting, difficulty breathing, asthma, and lowered blood pressure. If this occurs, your doctor will decide to either slow the rate at which Mylotarg is injected into your veins or will stop the injection altogether.
• low platelet count (thrombocytopenia). Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.
• a decline in liver function. Symptoms of liver decline is loss of appetite or weight, nausea, vomiting, stomach pain, and yellowing of the skin or whites of the eyes. Tell your healthcare provider about any signs or symptoms of liver damage.
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity including chest pain, swelling of the face or mouth, difficulty breathing or swallowing, and rash.
• QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Mylotarg. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation such as feeling faint, lightheaded, dizzy, or like your heart is beating irregularly or quickly.

Do not take Mylotarg if you:

• are allergic to Mylotarg or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mylotarg, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mylotarg, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mylotarg or to any of its ingredients
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is recommended to use contraceptives to prevent pregnancy during treatment and for at least 6 months after treatment for females and for at least 3 months after treatment for males.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mylotarg crosses into human milk. Because of the risk for adverse reactions, women should not breastfeed during treatment and for at least 1 month after last dose of Mylotarg.

Take Mylotarg exactly as prescribed. This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, contact your healthcare provider to reschedule. Your cycle schedule may have to be adjusted if you miss a dose.

The Mylotarg dose you receive is based on your height and weight which is used to calculate your body surface area. There are different types of treatment schedules and number of treatments that will be considered by your healthcare provider.

The dose your doctor recommends may be based on the following:

• if you have received prior AML treatment
• if you are taking other medications for AML
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Follow your doctor's instructions about your individual dosing schedule. It is important to keep all of your appointments to receive your Mylotarg dose.

• Newly-diagnosed, de novo AML (combination regimen):

  –Induction: 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine.

  –Consolidation: 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine.

• Newly-diagnosed AML (single-agent regimen):

  –Induction: 6 mg/m2 on Day 1 and 3 mg/m2 on Day 8.

  –Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of Mylotarg 2 mg/m2 on Day 1 every 4 weeks.

• Relapsed or refractory AML(single-agent regimen): 

  –3 mg/m2 on Days 1, 4, and 7.

If Mylotarg is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

It is recommended to receive certain medications before receiving an injection of Mylotarg to decrease the likelihood of an adverse reaction. These medications include a steroid, acetaminophen (Tylenol), and diphenhydramine (Benedryl).

Your healthcare provider will decide if these medications are appropriate for you.

WARNING: HEPATOTOXICITY

Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG.