Gemtuzumab Ozogamicin: uses, dosing, side effects & brands
Gemtuzumab Ozogamicin is a cd33-directed immunoconjugate sold in the U.S. under one brand, for acute myeloid leukemia and acute myelomonocytic leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Cd33-Directed Immunoconjugate
- Treats
- Acute Myeloid Leukemia and Acute Myelomonocytic Leukemia
- Available as
- Injectable
- Sold as
- Mylotarg
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How gemtuzumab ozogamicin is dosed
From the FDA label for Mylotarg (application BLA761060). Other gemtuzumab ozogamicin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Newly-diagnosed, de novo AML (combination regimen) Adults : - Induction: 3 mg/m 2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine ( 2.2 ). - Consolidation: 3 mg/m 2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine ( 2.2 ). Pediatric patients 1 month and older : - 3 mg/m 2 for patients with body surface area (BSA) 0.6 m 2 or greater ( 2.2 ). - 0.1 mg/kg for patients with BSA less than 0.6 m 2 ( 2.2 ). - See Full Prescribing Information for complete dosing information ( 2.2 ). • Newly-diagnosed AML (single-agent regimen): Adults : - Induction: 6 mg/m 2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m 2 (not limited to one 4.5 mg vial) on Day 8 ( 2.2 ). - Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of MYLOTARG 2 mg/m 2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks ( 2.2 ). • Relapsed or refractory AML (single-agent regimen): Adults and pediatric patients 2 years and older: - 3 mg/m 2 (up to one 4.5 mg vial) on Days 1, 4, and 7 ( 2.2 ). • Premedicate with a corticosteroid, antihistamine, and acetaminophen ( 2.1 ). 2.1 Premedication and Special Considerations • Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour prior to MYLOTARG dosing and 1 mg/kg…
Gemtuzumab Ozogamicin side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Hepatotoxicity, including VOD [see Warnings and Precautions (5.1) ] • Infusion-related reactions [see Warnings and Precautions (5.2) ] • Hemorrhage [see Warnings and Precautions (5.3) ] The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, mucositis, febrile neutropenia, and decreased appetite ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Combination Therapy in Newly-Diagnosed De Novo CD33-positive AML The safety of MYLOTARG in first-line combination therapy was evaluated in two prospective clinical trials, Study ALFA-0701 in adults and Study AAML0531 in pediatric patients. Study ALFA-0701 The safety evaluation of MYLOTARG (3 mg/m 2 Day 1, 4 and 7 in combination with daunorubicin and cytarabine [DA]) in adults is based on data from ALFA-0701 for 131 patients treated with MYLOTARG plus DA and in…
Who shouldn’t take gemtuzumab ozogamicin
MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . Hypersensitivity to MYLOTARG or any of its components ( 4 ).
Every gemtuzumab ozogamicin product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Mylotarg.
What people report to the FDA about gemtuzumab ozogamicin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,914 reports naming gemtuzumab ozogamicin, and the FDA flagged 99% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia360 reports
- sepsis148 reports
- venoocclusive liver disease145 reports
- thrombocytopenia136 reports
- pyrexia135 reports
- neutropenia107 reports
- pneumonia94 reports
- venoocclusive disease72 reports
Read these as a signal, not a rate. A report does not mean gemtuzumab ozogamicin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is gemtuzumab ozogamicin?
Mylotarg (Gemtuzumab Ozogamicin) is a cd33-directed immunoconjugate used to treat Acute Myeloid Leukemia, Acute Myelomonocytic Leukemia.
What kind of drug is gemtuzumab ozogamicin?
The FDA classifies gemtuzumab ozogamicin as a cd33-directed immunoconjugate. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take gemtuzumab ozogamicin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run gemtuzumab ozogamicin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does gemtuzumab ozogamicin come in?
Across the brands we track, gemtuzumab ozogamicin is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic gemtuzumab ozogamicin?
We do not currently list a generic-labelled gemtuzumab ozogamicin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Gemtuzumab Ozogamicin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gemtuzumab-ozogamicin
- MLA
- “Gemtuzumab Ozogamicin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gemtuzumab-ozogamicin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for gemtuzumab ozogamicin on DailyMed (NIH) ↗ — including its boxed warning in full.