Molecule
Gemtuzumab ozogamicin is a CD33-directed immunoconjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older, among other approved uses. MedsAcross supplies Gemtuzumab ozogamicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
MYLOTARG 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. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.
Source: US FDA prescribing information
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes human CD33 antigen. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Source: US FDA prescribing information
• 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. - Consolidation: 3 mg/m 2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine. Pediatric patients 1 month and older: - 3 mg/m 2 for patients with body surface area (BSA) 0.6 m 2 or greater. - 0.1 mg/kg for patients with BSA less than 0.6 m 2. - See Full Prescribing Information for complete dosing information. • 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. - 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.
Source: US FDA prescribing information
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. Hypersensitivity to MYLOTARG or any of its components.
Source: US FDA prescribing information
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. • Infusion-related reactions (including anaphylaxis): Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. Monitor patients during and for at least 1 hour after the end of the infusion. Interrupt the infusion, administer steroids or antihistamines, or permanently discontinue treatment as necessary. • Hemorrhage: Severe, including fatal, hemorrhage may occur when MYLOTARG is used at recommended doses. Monitor platelet counts frequently. • Embryo-fetal toxicity: Can cause fetal harm.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Hepatotoxicity, including VOD • Infusion-related reactions • Hemorrhage 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.
Source: US FDA prescribing information
Refrigerate (2°C to 8°C, 36°F to 46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Gemtuzumab ozogamicin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Mylotarg 5 mg/5 mL powder for injectionIntravenous Cold chain | Wyeth Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Gemtuzumab ozogamicin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Gemtuzumab ozogamicin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Gemtuzumab ozogamicin, including Mylotarg.
Yes. The US FDA first approved Gemtuzumab ozogamicin on 1 September 2017, according to Drugs@FDA.
Yes. Gemtuzumab ozogamicin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Gemtuzumab ozogamicin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Gemtuzumab ozogamicin is classified under ATC code L01FX02 (Gemtuzumab ozogamicin).
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