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MYLOTARG
Gemtuzumab Ozogamicin
$14480.00
5mg · 1 vial
BrandBranded medicine· By Pfizer
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FDA boxed warningHepatotoxicity
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. ( 5.1 and 6.1 )
About MYLOTARG
Overview
MYLOTARG (gemtuzumab ozogamicin) is an antibody linked to a cell-killing medicine, given by intravenous infusion. It treats newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and children aged 1 month and older. It also treats CD33-positive AML that has returned or has not responded to treatment in adults and children aged 2 years and older. It works by attaching to CD33 on leukemia cells and releasing a substance inside them that damages their DNA and causes cell death.
What it treats
- Newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and children aged 1 month and older. - CD33-positive AML that has returned (relapsed) or has not responded to treatment (refractory) in adults and children aged 2 years and older.
Safety information
Side effects
Common side effects include bleeding, infection, fever, nausea, vomiting, constipation, headache, increased liver enzymes, rash, inflammation or sores in the mouth and digestive tract, fever with low levels of infection-fighting white blood cells, and decreased appetite. Serious side effects include liver damage, including blockage of small blood vessels in the liver (veno-occlusive disease), infusion-related reactions including a severe allergic reaction (anaphylaxis), and severe bleeding that can be fatal. Contact a doctor immediately if you suspect any of these effects. The healthcare team will monitor you during the infusion and for at least one hour afterward, and check platelet counts frequently. MYLOTARG can harm an unborn baby. Use effective contraception if you can become pregnant or father a child, and contact your doctor if pregnancy occurs.
FDA boxed 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. ( 5.1 and 6.1 )
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use MYLOTARG if you have a history of an allergic reaction to gemtuzumab ozogamicin or any of its ingredients. Reactions have included anaphylaxis, a severe allergic reaction. MYLOTARG can cause infusion-related reactions, including anaphylaxis. Medicines are given beforehand to help reduce this risk, and patients must be monitored during the infusion and for at least one hour afterwards. Severe bleeding, including fatal bleeding, can occur. Platelet counts must be checked frequently. MYLOTARG can harm an unborn baby. Patients who could conceive or father a child should use effective contraception. Do not breastfeed during treatment.
Using MYLOTARG
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label MYLOTARG (GEMTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] (DailyMed, retrieved 19 September 2026).
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