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gemtuzumab ozogamicin

Mylotarg · ATC code 333

Also known as: Gemtuzumab ozogamisin

Key facts
Active substance
gemtuzumab ozogamicin
ATC code
333
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
MYLOTARG 5 mg powder for concentrate for solution for infusion
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-28

Key facts

Gemtuzumab ozogamicin (Mylotarg) is a CD33-directed antibody-drug conjugate used with chemotherapy to treat newly diagnosed CD33-positive acute myeloid leukaemia.

What it is used for

  • Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for patients aged 15 years and above with previously untreated de novo CD33-positive AML, except acute promyelocytic leukaemia (APL).
  • Only for patients eligible for intensive induction chemotherapy.

Dosing

  • Induction: 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over 2 hours on Days 1, 4 and 7, with DNR 60 mg/m2/day (Day 1 to 3) and AraC 200 mg/m2/day (Day 1 to 7).
  • If a second induction is required, MYLOTARG is not given; only DNR and AraC.
  • Consolidation after complete remission: up to 2 courses with MYLOTARG 3 mg/m2 on the first day in addition to DNR and AraC – details see the full text.
  • Premedication with a corticosteroid, antihistamine and paracetamol 1 hour before dosing; measures against tumour lysis-related hyperuricaemia.
  • Dose modifications for hyperleukocytosis, hepatic or haematological toxicity see the full text.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Hepatotoxicity including life-threatening veno-occlusive disease (VOD/SOS); check liver tests before each dose; higher risk in moderate/severe hepatic impairment and in relation to stem cell transplant.
  • Infusion-related reactions including anaphylaxis, some fatal.
  • Myelosuppression with severe infection and bleeding; blood counts before each dose.
  • Tumour lysis syndrome, including fatal cases with acute renal failure.
  • Benefit is uncertain in adverse-risk cytogenetics.

Side effects

  • In the combination study ALFA-0701 clinically relevant serious reactions: VOD/SOS (3.8%), haemorrhage (9.9%), severe infection (41.2%) and tumour lysis syndrome (1.5%).
  • In monotherapy studies also infusion-related reactions (2.5%) and thrombocytopenia (21.7%).

Interactions

  • No clinical drug interaction studies have been conducted.

Pregnancy and breastfeeding

  • Women of childbearing potential and partners should use 2 effective contraceptive methods during treatment and for at least 7 months (females) or 4 months (males) after the last dose.
  • Limited data in pregnancy; animal studies show reproductive toxicity.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • MylotargPfizer Europe MA EEIG · EMEA/H/C/004204

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Mylotarg
Liechtenstein
Mylotarg
Norway
Mylotarg

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Another question about this substance?

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Sources

  1. European Medicines Agency. Mylotarg – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/mylotarg-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.