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Anti-CD33 antibody-drug conjugate

Gemtuzumab ozogamicin (Specialist drug)

Brand names: Mylotarg

Gemtuzumab ozogamicin is an intravenous antibody-drug conjugate used by haemato-oncology specialists to treat 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

Its anti-CD33 antibody binds leukaemic blasts and, on internalisation, releases the DNA-damaging calicheamicin derivative that causes double-strand breaks and apoptosis.

Prescribing in practice

  • Hepatotoxicity, including potentially fatal veno-occlusive disease (sinusoidal obstruction syndrome), is a key risk and requires close monitoring of liver function and clinical vigilance, particularly around stem-cell transplant.
  • Severe and sometimes fatal infusion reactions can occur, so give premedication and administer under supervision with the infusion slowed or stopped if reactions develop.
  • Profound myelosuppression and tumour lysis syndrome can occur; ensure supportive care and blood-count monitoring.

Monitoring

Monitor liver function tests (watching for veno-occlusive disease), full blood count, and for infusion reactions and tumour lysis around each dose.

Counselling the patient

  • Report any fever, chills, breathlessness or rash during or after the infusion.
  • Tell your team about abdominal pain, swelling or yellowing of the skin or eyes.
  • Attend all blood tests, as your counts and liver will be monitored closely.

Evidence & guidelines

Gemtuzumab ozogamicin is licensed for CD33-positive acute myeloid leukaemia on the basis of randomised trial data, with its veno-occlusive disease risk well characterised in the SPC and haematology literature.

Reference: NICE TA545; SmPC; 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.