Mylotarg is a monoclonal antibody linked to a chemotherapy drug. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Mylotarg is used to treat a certain type (CD33-positive) of newly-diagnosed acute myeloid leukemia in adults and children at least 1 month old.

Mylotarg is also used to treat CD33-positive acute myeloid leukemia after other treatments did not work or have stopped working in adults and children at least 2 years old.

Mylotarg can increase your risk of bleeding or liver damage, either of which may be life-threatening.

Call your doctor at once if you have upper stomach pain, yellowing of your skin or eyes, rapid weight gain, swelling in your midsection, sudden numbness or weakness, problems with speech or vision, severe headache, or unusual bleeding (bleeding gums, vaginal bleeding, blood in your urine or stools, coughing up blood).

Before taking this medicine

You should not be treated with Mylotarg if you are allergic to gemtuzumab ozogamicin.

To make sure Mylotarg is safe for you, tell your doctor if you have:

• liver disease;

• long QT syndrome (in you or a family member);

• a stem cell transplant; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Gemtuzumab ozogamicin can harm an unborn baby or cause birth defects if the mother or the father is using Mylotarg.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using Mylotarg and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Mylotarg.

Mylotarg may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because gemtuzumab ozogamicin may harm the baby if a pregnancy does occur.

Do not breastfeed while using Mylotarg, and for at least 1 month after your last dose.

Mylotarg is given as an infusion into a vein. A healthcare provider will give you this injection.

Mylotarg is given in a treatment cycle, and you will receive it only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

You will be given other medications to help prevent serious side effects or an infusion reaction. Start and keep taking these medications exactly as your doctor has prescribed.

Mylotarg must be given slowly, and the infusion can take at least 2 hours to complete.

You will be watched closely for at least 1 hour after receiving Mylotarg, to make sure you do not have an infusion reaction.

Gemtuzumab ozogamicin may cause serious or life-threatening liver problems, including veno-occlusive disease (blocked blood vessels in the liver that can lead to liver damage).

You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Usual Adult Dose for of Mylotarg Acute Myeloid Leukemia:

Newly-diagnosed CD33-positive acute myeloid leukemia (AML):
COMBINATION REGIMEN (therapy consists of 1 induction cycle and 2 consolidation cycles in combination with chemotherapy):
-Induction: 3 mg/m2 (maximum 4.5 mg/dose) IV on Days 1, 4, and 7 in combination with daunorubicin and cytarabine (for patients who require a second induction cycle, gemtuzumab is NOT given during the second induction cycle)
-Consolidation (2 cycles): 3 mg/m2 (maximum 4.5 mg/dose) IV on Day 1 in combination with daunorubicin and cytarabine

Newly-diagnosed CD33-positive acute myeloid leukemia (AML):
SINGLE AGENT REGIMEN (MONOTHERAPY) (therapy consists of 1 induction cycle and up to 8 continuation cycles):
-Induction: 6 mg/m2 IV on Day 1 and 3 mg/m2 IV on Day 8
-Continuation: 2 mg/m2 IV on Day 1 every 4 weeks

Relapsed or Refractory CD33-positive AML:
SINGLE AGENT REGIMEN (MONOTHERAPY):
3 mg/m2 (maximum 4.5 mg/dose) IV on Days 1, 4, and 7
-Treatment in the relapsed or refractory setting consists of a single course of gemtuzumab.

Comments:
-Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or IV one hour prior to infusion, and methylprednisolone (or equivalent) 1 mg/kg orally or IV within 30 minutes prior to infusion. Repeat the same dose of methylprednisolone (or equivalent) for any sign of an infusion reaction (e.g., fever, chills, hypotension, dyspnea) during the infusion or within 4 hours of the infusion.
-Monitor vital signs during infusion and for 4 hours following infusion.
-For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of this drug.

Usual Pediatric Dose of Mylotarg for Acute Myeloid Leukemia:

Newly Diagnosed De Novo CD33-positive AML (Combination Regimen):
ONE MONTH AND OLDER:
-Body surface area (BSA) less than 0.6 m2: 0.1 mg/kg
-BSA 0.6 m2 or greater: 0.3 mg/m2
INDUCTION 1:
-For Induction 1, gemtuzumab is given once in combination with standard chemotherapy; no gemtuzumab is given in the second induction cycle.
INTENSIFICATION:
-No gemtuzumab is given in the first or third intensification cycles; for Intensification 2, gemtuzumab is given once in combination with standard chemotherapy; consider the risks and potential benefits before giving gemtuzumab during Intensification 2.

Relapsed or Refractory CD33-positive AML:
SINGLE AGENT REGIMEN (MONOTHERAPY):
2 YEARS AND OLDER:
3 mg/m2 (maximum 4.5 mg/dose) IV on Days 1, 4, and 7
-Treatment in the relapsed or refractory setting consists of a single course of gemtuzumab.

Comments:
-Premedicate children 1 month and older with acetaminophen 15 mg/kg (maximum of 650 mg) orally and diphenhydramine 1 mg/kg (maximum of 50 mg) orally or IV within 1 hour of infusion, and methylprednisolone 1 mg/kg orally or IV within 30 minutes of infusion. Additional doses of acetaminophen and diphenhydramine may be administered every 4 hours if needed. Repeat with the same dose of methylprednisolone (or equivalent) for an infusion reaction (e.g., fever, chills, hypotension, dyspnea) during the infusion or within 4 hours of the infusion.
-Monitor vital signs during infusion and for 4 hours following infusion.
-For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of this drug.

You should not be treated with Mylotarg if you are allergic to gemtuzumab ozogamicin.

To make sure Mylotarg is safe for you, tell your doctor if you have:

• liver disease;

• long QT syndrome (in you or a family member);

• a stem cell transplant; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Gemtuzumab ozogamicin can harm an unborn baby or cause birth defects if the mother or the father is using Mylotarg.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using Mylotarg and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Mylotarg.

Mylotarg may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because gemtuzumab ozogamicin may harm the baby if a pregnancy does occur.

Do not breastfeed while using Mylotarg, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your Mylotarg.

Since Mylotarg is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction to Mylotarg: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver right away if you feel cold, itchy, feverish, light-headed, or short of breath. These symptoms could also occur up to 1 hour after your Mylotarg injection.

Call your doctor at once if you have:

• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

• signs of liver problems - right-sided upper stomach pain, jaundice (yellowing of the skin or eyes), rapid weight gain, swelling in your arms or legs, painful swelling in your midsection;

• low blood cell counts - fever, flu symptoms, swollen gums, skin sores, cough, trouble breathing, pale skin, unusual tiredness;

• unusual bleeding - bleeding gums, abnormal vaginal bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds; or

• signs of bleeding in the brain - sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or vision.

Mylotarg can increase your risk of bleeding or liver damage, either of which may be life-threatening. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Mylotarg side effects may include:

• bleeding;

• fever, infection;

• mouth sores;

• nausea, vomiting, constipation;

• headache; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Mylotarg can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs interact with gemtuzumab ozogamicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.