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
Important Disclaimer
The Darzalex 20 mg/mL Concentrate for solution for infusion professional information leaflet below is the property of Janssen Pharmaceutica (Pty) Ltd and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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