Darzalex 20 mg/mL Concentrate for solution for infusion
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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