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.
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).
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:
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 gemtuzumab ozogamicin, 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 gemtuzumab ozogamicin 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;
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
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.
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.
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.01.
More about gemtuzumab
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
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- Drug class: CD33 monoclonal antibodies
Other brands: Mylotarg