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gemtuzumab ozogamicin

Generic Name: gemtuzumab ozogamicin (jem TOOZ ue mab OH zoe ga MYE sin)
Brand Name: Mylotarg

What is gemtuzumab ozogamicin?

Gemtuzumab ozogamicin 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.

Gemtuzumab ozogamicin is used to treat a certain type of acute myeloid leukemia, and is sometimes given when this condition has come back or has not responded after prior chemotherapy.

Gemtuzumab ozogamicin may also be used for purposes not listed in this medication guide.

Important Information

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

Call your doctor at once if you have signs of liver problems, such as upper stomach pain, jaundice (yellowing of the skin or eyes), rapid weight gain, or painful swelling in your midsection.

Gemtuzumab ozogamicin can also weaken (suppress) your immune system, and you may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, flu symptoms, unusual tiredness, mouth sores, pale skin, cough, trouble breathing).

Avoid getting pregnant while receiving gemtuzumab ozogamicin and for at least 6 months after your last dose.

Before taking this medicine

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • 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).

You may need to have a negative pregnancy test before starting this treatment.

Gemtuzumab ozogamicin can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Men should use condoms. Gemtuzumab ozogamicin use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 6 months after your last dose of gemtuzumab ozogamicin. If you are a man, keep using condoms 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 gemtuzumab ozogamicin.

This medicine 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.

It is not known whether gemtuzumab ozogamicin passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using this medicine and for at least 1 month after your last dose.

How is gemtuzumab ozogamicin given?

Gemtuzumab ozogamicin is injected into a vein through an IV. A healthcare provider will give you this injection. Gemtuzumab ozogamicin is sometimes given in combination with other cancer medicines.

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.

Gemtuzumab ozogamicin 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 this medicine, to make sure you do not have an infusion reaction.

Gemtuzumab ozogamicin 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.

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 to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your gemtuzumab ozogamicin injection.

What happens if I overdose?

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

What should I avoid while receiving gemtuzumab ozogamicin?

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Gemtuzumab ozogamicin side effects

Get emergency medical help if you have signs of an allergic reaction: 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 gemtuzumab ozogamicin 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.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

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.

See also: Side effects (in more detail)

Gemtuzumab ozogamicin dosing information

Usual Adult Dose for 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

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.

Uses:
-For newly-diagnosed CD33-positive acute myeloid leukemia (AML)
-For relapsed or refractory CD33-positive AML

Usual Pediatric Dose for Acute Myeloid Leukemia:

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

Comments:
-Premedicate children 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.

Use:
-For relapsed or refractory CD33-positive acute myeloid leukemia (AML) in pediatric patients 2 years and older

What other drugs will affect gemtuzumab ozogamicin?

Gemtuzumab ozogamicin can cause a serious heart problem, especially if you use certain medicines at the same time, such as antibiotics, antifungal medicine, antidepressants, anti-malaria medicine, asthma inhalers, antipsychotic medicine, certain HIV/AIDS medicine, heart or blood pressure medicine, or medicine to prevent vomiting. Tell your doctor about all your current medicines and any medicine you start or stop using.

Other drugs may 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about gemtuzumab ozogamicin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01.

Date modified: January 03, 2018
Last reviewed: October 10, 2017

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