Daratumumab 400mg/20ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Daratumumab
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Daratumumab
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1 branded products available
MHRA licensed products
View all licensed products for Daratumumab on the MHRA register
Darzalex 400mg/20ml concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(14)
Daratumumab monotherapy for treating relapsed and refractory multiple myeloma (TA783)
Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma (TA897)
Daratumumab in combination for treating newly diagnosed systemic amyloid light-chain amyloidosis (TA959)
Daratumumab in combination for untreated multiple myeloma when a stem cell transplant is suitable (TA763)
Daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable (TA917)
Daratumumab with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable (TA1170)
Daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma (terminated appraisal) (TA634)
Daratumumab with bortezomib, melphalan and prednisone for untreated multiple myeloma (terminated appraisal) (TA771)
Daratumumab with pomalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal) (TA726)
Carfilzomib with daratumumab and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal) (TA841)
Daratumumab with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal) (TA454)
Belantamab mafodotin with pomalidomide and dexamethasone for previously treated multiple myeloma (TA1133)
Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma (TA658)
Selinexor with bortezomib and dexamethasone for previously treated multiple myeloma (TA974)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
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Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 8 · Randomised trials: 15 · 2015–2026
Showing the 50 most relevant studies, sorted by most relevant.
Sagar Lonial, Brendan M. Weiss, Saad Z. Usmani, et al.
The Lancet, 2016
- Antibodies, Monoclonal
- Antineoplastic Agents
- Antineoplastic Combined Chemotherapy Protocols
María‐Victoria Mateos, Michèle Cavo, Joan Bladé, et al.
The Lancet, 2019
- Bortezomib
- Antibodies, Monoclonal
- Asia
Thierry Façon, Shaji Kumar, Torben Plesner, et al.
The Lancet Oncology, 2021
- Lenalidomide
- Progression-Free Survival
- Antibodies, Monoclonal
Meletios Α. Dimopoulos, Evangelos Terpos, Mario Boccadoro, et al.
The Lancet Oncology, 2021
- Progression-Free Survival
- Antibodies, Monoclonal
- Antineoplastic Combined Chemotherapy Protocols
María‐Victoria Mateos, Hareth Nahi, Wojciech Legieć, et al.
The Lancet Haematology, 2020
- Antibodies, Monoclonal
- Antineoplastic Agents
- Injections, Subcutaneous
Peter M. Voorhees, Douglas W. Sborov, Jacob P. Laubach, et al.
The Lancet Haematology, 2023
- Multiple Myeloma
- Thrombocytopenia
- Bortezomib
Philippe Moreau, Cyrille Hulin, Aurore Perrot, et al.
The Lancet Oncology, 2021
- Bortezomib
- Progression-Free Survival
- Antibodies, Monoclonal
Meletios Α. Dimopoulos, Albert Oriol, Hareth Nahi, et al.
Journal of Clinical Oncology, 2023
- Multiple Myeloma
- Lenalidomide
- Antibodies, Monoclonal
Marie‐Therese Holzer, Nikolas Ruffer, Tobias B. Huber, et al.
RMD Open, 2023
- Antibodies, Monoclonal
- Autoimmune Diseases
- Rituximab
S. Usmani, T. Facon, V. Hungria, et al.
Nature Medicine, 2025
- Bortezomib
- Lenalidomide
- Progression-Free Survival
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
9 days
Mechanism
CD38 is a glycoprotein present on the surface of hematopoietic cells and is resp…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
592µg/mL
[L13296]…
Half-life
9 days
[L13290]
Subcutaneous daratumumab has a half life of 20 days.
[L13296]
Protein binding
[L13290][L13296]
Volume of distribution
1.3L
Metabolism
[A19126]
Elimination
[A19126]
Clearance
95.3mL
[L13290]
Subcutaneous daratumumab has a clearance of 119mL/day.
[L13296]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Daratumumab was granted FDA approval on 16 November 2015.[L13290] It is approved for the treatment of multiple myeloma as monotherapy or combination therapy and light chain (AL) amyloidosis in combination with other drugs.[L13290][L13296]
A subcutaneous formulation of daratumumab co-formulated with hyaluronidase-fihj is also approved for the treatment of adults with multiple myeloma. In July 2024, it was further approved in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy in newly diagnosed, transplant-eligible patients. This approval was based on results from the Phase 3 PERSEUS study, which demonstrated significant improvement in progression-free survival and higher rates of minimal residual disease (MRD) negativity compared to standard VRd therapy.[L52535]. Most recently, in November 2025, the subcutaneous formulation received approval as a monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma. [L54658]
[L13290]
Daratumumab is also approved for subcutaneous administration in combination with hyaluronidase (human recombinant) for the treatment of adults with multiple myeloma (as monotherapy or in combination), light chain (AL) amyloidosis (in combination), and high-risk smoldering multiple myeloma (as monotherapy).
[L13296][L52535][L54658]
"
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 417 interactions
[L13290][L13296]
Patients should be treated with symptomatic and supportive measures.
[L13290][L13296]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L13296]
The AUC of subcutaneous daratumumab is 4017µg/mL\*day compared to intravenous daratumumab, which has an AUC of 4019µg/mL\*day.
[L13296]
[L13290]
Subcutaneous daratumumab has a half life of 20 days.
[L13296]
[L13290][L13296]
[L13290]
Subcutaneous daratumumab has a volume of distribution of the central compartment of 5.2L and a volume of distribution of the peripheral compartment of 3.8L.
[L13296]
[A19126]
[A19126]
[L13290]
Subcutaneous daratumumab has a clearance of 119mL/day.
[L13296]
Proteins and enzymes this drug interacts with in the body
PMID:7961800 PMID:8253715
Synthesizes the Ca(2+) mobilizer nicotinate-adenine dinucleotide phosphate, NAADP(+), from 2'-phospho-cADPR and nicotinic acid, as well as from NADP(+) and nicotinic acid. At both pH 5.0 and pH 7.4 preferentially transforms 2'-phospho-cADPR into NAADP(+), while preferentially cleaving NADP(+) to cADPR and ADPRP rather than into NADDP(+) .
PMID:16690024
Has cADPR hydrolase activity PMID:7961800 PMID:8253715
ATC L01FC01
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Daratumumab
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q5222113), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.