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Antibody-Drug Conjugate — AML Pregnancy: Contraindicated — genotoxic and embryotoxic; effective contraception required during and for 7 months (women) or 4 months (men) after treatment

Gemtuzumab Ozogamicin

Brand names: Mylotarg

Adult dose

Dose: 3 mg/m² IV on days 1, 4, and 7 (combined with daunorubicin + cytarabine induction)
Route: IV infusion over 2 hours
Frequency: Days 1, 4, 7 of induction cycle
Max: 3 mg/m² per dose (max 4.5 mg per dose — rounded to nearest vial)
Anti-CD33 antibody conjugated to calicheamicin (cytotoxic). Used in newly diagnosed CD33+ AML (combined with 7+3 induction — ALFA-0701 regimen) and relapsed/refractory CD33+ AML (monotherapy 3 mg/m² days 1, 4, 7 or fractionated dosing). Must test for CD33 expression before use.

Paediatric dose

Dose: 0.1 mg/kg (if <10 kg) mg/kg
Route: IV infusion over 2 hours
Frequency: Days 1, 4, 7 of induction cycle
Max: 3 mg/m² per dose if ≥10 kg
BNFc: licensed in children ≥2 years with newly diagnosed CD33+ AML. Weight-based dosing for <10 kg.

Dose adjustments

Renal

No dose adjustment required

Hepatic

Avoid if bilirubin >2× ULN — risk of severe hepatotoxicity and sinusoidal obstruction syndrome (SOS)

Paediatric weight-based calculator

BNFc: licensed in children ≥2 years with newly diagnosed CD33+ AML. Weight-based dosing for <10 kg.

Clinical pearls

  • ALFA-0701 trial: fractionated dose 3 mg/m² × 3 with 7+3 induction significantly improved EFS and OS in newly diagnosed AML (especially favourable-risk and intermediate-risk cytogenetics)
  • Sinusoidal obstruction syndrome (SOS/VOD): most serious toxicity — hepatomegaly, weight gain, ascites, hyperbilirubinaemia, right upper quadrant pain; fatal in severe cases
  • SOS risk increased in patients proceeding to HSCT — timing and conditioning regimen selection important; discuss with transplant team
  • Monitor LFTs closely during and for 4 weeks post-treatment — delay or discontinue if significant hepatic toxicity
  • CD33 expression must be confirmed (IHC or flow cytometry) before use
  • Re-introduced after market withdrawal in 2010 (initial high-dose single infusion caused excess mortality from SOS) — fractionated lower dose regimen is safer

Contraindications

  • Bilirubin >2× ULN
  • Severe hepatic impairment
  • CD33-negative AML
  • Pregnancy

Side effects

  • Sinusoidal obstruction syndrome / veno-occlusive disease (SOS/VOD — most serious)
  • Myelosuppression
  • Infusion-related reactions
  • Haemorrhage (thrombocytopenia)
  • Nausea/vomiting
  • Hepatotoxicity
  • Prolonged thrombocytopenia

Interactions

  • No clinically significant pharmacokinetic interactions; additive hepatotoxicity with other hepatotoxic agents

Monitoring

  • LFTs (before each dose and weekly for 4 weeks after last dose)
  • Bilirubin
  • FBC
  • Weight and fluid balance (SOS surveillance)
  • Infusion-related reactions

Reference: BNFc; BNF 90; BNFc; ALFA-0701 Trial (Castaigne et al. Lancet 2012); NICE TA545; SPC Mylotarg. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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