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Antibody-Drug Conjugate — AML

Gemtuzumab Ozogamicin

Brand names: Mylotarg

Gemtuzumab ozogamicin is an antibody-drug conjugate targeting CD33, used in the treatment of CD33-positive acute myeloid leukaemia.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

The anti-CD33 antibody delivers a cytotoxic calicheamicin payload into leukaemic cells, where it causes DNA damage and cell death.

Prescribing in practice

  • It can cause hepatotoxicity including veno-occlusive disease (sinusoidal obstruction syndrome), which can be fatal, so liver function and clinical signs must be monitored closely.
  • Severe infusion-related reactions and tumour lysis syndrome can occur, requiring premedication and monitoring.
  • It causes profound myelosuppression with risk of serious infection and bleeding.

Monitoring

Monitor liver function tests, full blood count, and for signs of veno-occlusive disease, infusion reactions and tumour lysis during treatment.

Counselling the patient

  • Report yellowing of the skin or eyes, abdominal swelling or sudden weight gain promptly.
  • Seek urgent help for fever, bleeding or signs of infection.
  • This treatment is given under close specialist haematology supervision.

Evidence & guidelines

Gemtuzumab ozogamicin improves outcomes in CD33-positive acute myeloid leukaemia, supported by randomised trial evidence and its licensed indication.

Reference: ALFA-0701 Trial (Castaigne et al. Lancet 2012); NICE TA545; SPC Mylotarg; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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