Prescription medicine
Gemtuzumab ozogamicin Brand names: Mylotarg
Gemtuzumab ozogamicin (Mylotarg) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the gemtuzumab ozogamicin FDA label on DailyMed (effective December 19, 2025, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the BLA 761060 record on Drugs@FDA; every gemtuzumab ozogamicin label on DailyMed.
Highlights of the record
FDA label of December 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. 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.
Used for
From the label: indications and usageMYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ).
Forms and strengths
- 5 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- September 1, 2017 Mylotarg, Wyeth Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,635 through July 30, 2026
What is gemtuzumab ozogamicin used for?
From the label: indications and usageMYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). […]
Conditions named in the indications of gemtuzumab ozogamicin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD33-directed Immunoconjugate.
Source: FDA drug label (Mylotarg), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective December 19, 2025 (SPL set 32fd2bb2-1cfa-4250-feb8-d7956c794e05), via openFDA; the full label on DailyMed
Is there a generic for gemtuzumab ozogamicin (Mylotarg)?
No generic gemtuzumab ozogamicin is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gemtuzumab ozogamicin label say about other medicines?
The gemtuzumab ozogamicin label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Infusion-related reactions (including anaphylaxis): Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. |
| Cytarabine | warnings and precautions | For patients being treated with MYLOTARG in combination with daunorubicin and cytarabine for newly-diagnosed de novo AML, when cytogenetics testing results become available consider whether the potential benefit of continuing treatment with MYLOTARG outweighs the risks for the individual patient. |
| Daunorubicin | warnings and precautions | For patients being treated with MYLOTARG in combination with daunorubicin and cytarabine for newly-diagnosed de novo AML, when cytogenetics testing results become available consider whether the potential benefit of continuing treatment with MYLOTARG outweighs the risks for the individual patient. |
| Diphenhydramine | warnings and precautions | Infusion-related reactions (including anaphylaxis): Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. |
Source: FDA drug label (Mylotarg), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective December 19, 2025 (SPL set 32fd2bb2-1cfa-4250-feb8-d7956c794e05), via openFDA; the full label on DailyMed
What do FAERS reports show for gemtuzumab ozogamicin?
The FDA Adverse Event Reporting System holds 3,635 reports that list gemtuzumab ozogamicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,126 are coded as a death and 1,745 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as gemtuzumab ozogamicin?
36 other medicines are given the same way (intravenous) and in the same FDA class as gemtuzumab ozogamicin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Gemtuzumab ozogamicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other