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daratumumab

Darzalex · ATC code L01FC01

Key facts
Active substance
daratumumab
ATC code
L01FC01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
DARZALEX 20 mg/mL concentrate for solution for infusion · DARZALEX 1800 mg solution for injection
Marketing authorisation holder
2168
Information as of
2026-10-27

Key facts

Daratumumab is an IgG1 monoclonal antibody directed against CD38. It is used in adults with multiple myeloma, alone or combined with other myeloma therapies.

What it is used for

  • Newly diagnosed multiple myeloma ineligible for autologous stem cell transplant (with lenalidomide/dexamethasone or bortezomib/melphalan/prednisone)
  • Newly diagnosed multiple myeloma eligible for transplant (with bortezomib/thalidomide/dexamethasone)
  • Multiple myeloma after at least one prior therapy (with lenalidomide or bortezomib plus dexamethasone)
  • Monotherapy for relapsed and refractory multiple myeloma after a proteasome inhibitor and an immunomodulatory agent
  • Subcutaneous formulation only: further combinations (e.g. pomalidomide/dexamethasone) and indications per the full text

Dosing

  • Intravenous infusion (20 mg/mL): 16 mg/kg body weight; in 4-week cycles weekly in weeks 1 to 8, every two weeks in weeks 9 to 24, every four weeks from week 25 until progression
  • Subcutaneous injection: 1800 mg over approximately 3-5 minutes on the same schedule; subcutaneous use only, not intravenous
  • Dexamethasone 40 mg/week (reduced to 20 mg/week for patients over 75 years)
  • Pre- and post-medication to reduce infusion-related reactions; give where resuscitation facilities are available
  • Other schedules (e.g. 6-week cycles with bortezomib/melphalan/prednisone) in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Infusion-related reactions including anaphylaxis, which can be life-threatening; mostly with the first dose; monitor during and after administration
  • Ocular reactions (choroidal effusion, acute myopia, acute angle closure glaucoma)
  • Hepatitis B reactivation, in some cases fatal; screen for HBV before starting
  • Interference with the indirect antiglobulin (Coombs) test, up to 6 months after the last dose
  • Traceability: record name and batch number

Side effects

  • Most frequent (≥20%): infusion-related reactions, fatigue, nausea, diarrhoea, constipation, pyrexia, cough, neutropenia, thrombocytopenia, anaemia, peripheral oedema, peripheral neuropathy, upper respiratory tract infection, COVID-19
  • Serious: sepsis, pneumonia, bronchitis, pulmonary oedema, dehydration, atrial fibrillation, syncope
  • Subcutaneous formulation: lower rate of infusion-related reactions

Interactions

  • No clinically relevant interactions with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone
  • Positive indirect Coombs test can interfere with blood transfusion work-up

Pregnancy and breastfeeding

  • Women of childbearing potential: effective contraception during and for 3 months after treatment; not recommended in pregnancy
  • Unknown whether daratumumab is excreted in human milk

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Turkey

  • DarzalexJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Darzalex
Liechtenstein
Darzalex
Norway
Darzalex

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Darzalex – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.