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Gemtuzumab Ozogamicin is available as a 4.5 mg IV injection.

Gemtuzumab Ozogamicin is an antibody-drug conjugate and is used for the following:

• Newly-diagnosed acute myeloid leukemia (AML) that’s
• CD33-positive in adults and children 1 month or older
• Previously-treated acute myeloid leukemia (AML) that’s
• CD33-positive in adults and children 2 years and older

Gemtuzumab Ozogamicin is a type of cancer medication known as an antibody-drug conjugate. It’s made up of two parts: a monoclonal antibody and a chemotherapy drug called calicheamicin. The antibody takes Gemtuzumab Ozogamicin to acute myeloid leukemia cells in the body that have a specific protein called CD33. Once there, the chemotherapy damages the leukemia cell’s DNA, which kills the cancer cell.

The dose and treatment schedule depends on your age, your AML status, and whether you’re taking Gemtuzumab Ozogamicin along with other chemotherapy.

• In general, Gemtuzumab Ozogamicin is given as an infusion through the vein (IV) by a healthcare provider.
• First-choice treatment for newly-diagnosed AML

Adults

• The dose is based on your body size using body surface area (BSA), which takes into account your weight and height
• When used together with other chemotherapy: A treatment course consists of 1 induction cycle and then 2 consolidation cycles
• Induction cycle: The typical dose is 3 mg/m2 given IV on days 1, 4 and 7
• Consolidation cycles: The typical dose is 3 mg/m2 given IV on day 1.
• When used by itself: A treatment course consists of 1 induction cycle and up to 8 consolidation cycles
• Induction cycle: The typical dose is 6 mg/m2 given IV on day 1 and then 3 mg/m2 given IV on day 8
• Consolidation cycles: The typical dose is 2 mg/m2 given IV on day 1 every 4 weeks
• Children 1 month and older: Treatment days vary based on the treatment protocol that the healthcare team is following. The dose is based on body size, either using body surface area (mg/m2) or using body weight (mg/kg)
• Previously-treated AML
• People 2 years and older: The typical dose is 3 mg/m2 given IV on days 1, 4, and 7 for one course of treatment

Gemtuzumab Ozogamicin is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Gemtuzumab Ozogamicin:

• Fever
• Liver problems
• Tiredness
• Infection
• Heart problems
• Bleeding
• Nausea and vomiting
• Constipation
• Mouth sores

Serious side effects are rare with Gemtuzumab Ozogamicin. Contact your healthcare provider immediately if you experience any of the following.

• Serious liver problems: swollen belly, sudden weight gain, yellow skin, yellow eyes, stomach pain
• Bleeding: nosebleeds, blood in stool, unexplained bruising, blood in urine, sudden headache
• Infusion-related reactions: fever, fast heart rate, chills, trouble breathing, low blood pressure

There are no major drug interactions listed for Gemtuzumab Ozogamicin. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking.

Various FDA-approved generic manufacturers

Based on its mechanism of action and findings from animal studies, Gemtuzumab Ozogamicin can cause embryo-fetal harm when administered to a pregnant woman. Females who can become pregnant should use effective contraception during treatment with Gemtuzumab Ozogamicin and for at least 6 months after the final dose. Males with female partners of reproductive potential to use effective contraception during treatment with Gemtuzumab Ozogamicin and for at least 3 months after the last dose.

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