2025 Medication Fact Sheets Full Document_100825

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Gemtuzumab Ozogamicin (gem-TOO-zoo-mab OH-zoh-ga-MIH-sin) (Mylotarg®) What is this medication used for? Gemtuzumab ozogamicin, a monoclonal antibody linked to an antitumor agent, is used in the treatment of acute myeloid leukemias.

What does it look like? • Liquid How is it given?

What are the rare but serious side effects? • Allergic reactions • Lung damage • Serious bleeding in the head or nose or in the stool or urine • Liver damage, including blockage of veins in the liver Special instructions: • Premedications are often given before gemtuzumab ozogamicin to help prevent flu-like symptoms or allergic reactions. • Gemtuzumab ozogamicini is in an ultraviolet protective IV bag to protect it from light. • Vital signs will be watched closely during and following the infusion. • Complete blood counts, potassium level, and liver function will be monitored closely. • Call your healthcare provider if rapid weight gain or a decrease in urine quantity or urination frequency occurs. • Allergic reactions can occur during infusion and within 24 hours after infusion. Fever, chills, fast heartbeat, trouble breathing, skin rashes, or dizziness should be reported to your healthcare provider immediately. • In utero exposure may cause fetal harm.

• Into the vein (IV) or venous access device What are the common side effects? • Fever and chills (more common with first dose) • Headache • Nausea and vomiting • Constipation • Shortness of breath • Pain in the belly (abdomen) • Tiredness (fatigue) or weakness • Mouth sores • Low potassium level • Low blood cell counts What are the less common side effects? • Rash, hives, or itchiness (pruritis) during transfusion • High or low blood pressure • Cough • Upset stomach • Increase in blood sugar • Difficulty sleeping (insomnia) • Low levels of magnesium, calcium, or phosphorus in the blood • Anxiety or depression

Notes from Your Healthcare Team

Not all of the possible side effects of this medicine and precautions related to taking it are covered in this information sheet. For a complete list of side effects and precautions, ask your healthcare professional (doctor, nurse, pharmacist) for a manufacturer’s package insert or another reference.

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