Darzalex 20 mg/mL Concentrate for solution for infusion

Darzalex 20 mg/mL Concentrate for solution for infusion

S4
PDF Leaflet Revision Date: 15 January 2026


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of multiple myeloma.

Dosage (summary)

16 mg/kg IV infusion; schedule varies by therapy type.

Special Populations

  • Renal impairment
  • Hepatic impairment
  • Elderly

Pregnancy & Breastfeeding

Contraindicated in pregnancy; avoid breastfeeding.

Key Drug Interactions

  • Live attenuated vaccines
  • Indirect Coombs test interference

Contraindications

  • Hypersensitivity to daratumumab
  • Pregnancy
  • Breastfeeding

Common side effects

  • Infusion-related reactions
  • Fatigue
  • Nausea
  • Diarrhoea
  • Neutropenia

Counselling Points

  • Pre-medicate to reduce IRRs
  • Monitor for signs of infection
  • Avoid live vaccines

Serious warnings

  • Serious infusion-related reactions
  • HBV reactivation risk

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Darzalex 20 mg/mL Concentrate for solution for infusion
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