Key points
- Daratumumab (Darzalex) is an antibody that sticks to myeloma cells and destroys them, both directly and with the help of the immune system [1, 2].
- It comes in two forms: an IV drip that takes several hours, and an injection under the skin of the abdomen over about 3 to 5 minutes [1, 2].
- It is used with other drugs at almost every stage of multiple myeloma; the under-the-skin form is also approved in some situations before full myeloma (high-risk smouldering myeloma) and for amyloidosis [1, 2].
- A reaction during the injection is the main problem with the first dose; it is much less common with the under-the-skin form [1, 2].
- For 6 months after the last dose, tell the blood bank before any blood transfusion that you have had this drug; it interferes with one of the blood matching tests [1, 2].
What is this drug and how does it work?
For physicians
Daratumumab (brand name Darzalex) is a human IgG1κ monoclonal antibody that binds CD38, a glycoprotein on the surface of haematopoietic cells, including malignant plasma cells in multiple myeloma [1, 2].
It inhibits the growth of CD38-expressing cells in several ways: direct induction of apoptosis and immune-mediated cell destruction through complement (CDC), killer cells (ADCC) and phagocytosis (ADCP). It also reduces some CD38-positive immunosuppressive cells [1].
The subcutaneous form (Darzalex Faspro) is combined with the enzyme recombinant hyaluronidase, which temporarily increases the permeability of the subcutaneous tissue so that the 15 mL dose can be injected in a few minutes [2]. In the COLUMBA trial, the subcutaneous form was non-inferior to the intravenous form for response and drug levels in the blood (overall response 41% vs 37%) [8].
Which cancers is it used for?
What is this drug for?
Your doctor may prescribe this drug for:
- Newly diagnosed multiple myeloma, not suitable for a transplant [1, 2]
- Newly diagnosed multiple myeloma, suitable for a transplant [1, 2]
- Multiple myeloma that has come back or not responded [1, 2]
- Multiple myeloma that has come back after at least one line of treatment (including a proteasome inhibitor and an immunomodulatory drug) [7]
- High-risk smouldering myeloma [2]
- Newly diagnosed light-chain (AL) amyloidosis [2]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Setting |
|---|---|
| Newly diagnosed multiple myeloma, transplant-ineligible | With lenalidomide and dexamethasone (DRd); or with bortezomib, melphalan and prednisone; or (subcutaneous form) with bortezomib, lenalidomide and dexamethasone [1, 2] |
| Newly diagnosed multiple myeloma, transplant-eligible | Induction and consolidation with bortezomib, lenalidomide and dexamethasone (D-VRd, subcutaneous form) or with bortezomib, thalidomide and dexamethasone [1, 2] |
| Relapsed or refractory multiple myeloma | With lenalidomide, bortezomib, carfilzomib or pomalidomide and dexamethasone; or monotherapy after at least 3 lines of treatment [1, 2] |
| Multiple myeloma relapsed after at least one line of treatment (including a proteasome inhibitor and an immunomodulatory drug) | Subcutaneous form with teclistamab [7] |
| High-risk smouldering myeloma | Subcutaneous form, monotherapy, up to 3 years or until multiple myeloma is diagnosed [2] |
| Newly diagnosed light-chain (AL) amyloidosis | Subcutaneous form with bortezomib, cyclophosphamide and dexamethasone; not recommended in NYHA IIIB/IV heart disease or Mayo stage IIIB [2] |
The intravenous form is not approved for smouldering myeloma or AL amyloidosis [1]. The exact approved combinations may differ between countries.
| Cancer | Key evidence |
|---|---|
| Newly diagnosed multiple myeloma, transplant-ineligible | MAIA: 30-month progression-free survival 70.6% with DRd vs 55.6% with Rd; HR 0.56 [3] |
| Newly diagnosed multiple myeloma, transplant-eligible | PERSEUS: 48-month progression-free survival 84.3% vs 67.7% with VRd; HR 0.42 [4] |
| Multiple myeloma relapsed after at least one line of treatment (including a proteasome inhibitor and an immunomodulatory drug) | MajesTEC-3: 36-month progression-free survival 83.4% vs 29.7% with DPd or DVd; HR 0.17 [6] |
| High-risk smouldering myeloma | AQUILA: 5-year progression-free survival 63.1% vs 40.8% with active monitoring; HR 0.49 [5] |
How it is taken and dosing
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Treatment regimens and doses: index8 regimens
- Daratumumab is always given by healthcare staff at a treatment centre: either as an intravenous infusion, where the first infusion takes about 7 hours and later ones about 3 to 4 hours, or as an injection under the skin of the abdomen, which takes about 3 to 5 minutes [1, 2].
- It is usually given once a week for the first 8 weeks, then every 2 (or 3) weeks and later every 4 weeks; the exact schedule depends on your combination regimen [1, 2].
- 1 to 3 hours before each dose, medicines to prevent a reaction (paracetamol, an antihistamine and a steroid) are given, and you may also take a steroid tablet the next day [1, 2].
- Your blood group and an antibody screening test are done before starting [1, 2].
- To prevent shingles, an antiviral medicine is prescribed from the first week until 3 months after treatment ends [1, 2].
- If a dose is missed, it is given as soon as possible and the schedule is adjusted; do not stop treatment without talking to your doctor [1, 2].
Shared safety points
- Before starting: blood typing and antibody screening (daratumumab makes the indirect Coombs test positive for up to 6 months after the last dose; inform the blood bank) [1, 2].
- Intravenous: diluted in 0.9% sodium chloride with a 0.2 or 0.22 µm PES filter. Week 1: 1000 mL (or split as 8 + 8 mg/kg on days 1 and 2, 500 mL each), starting at 50 mL/h and increasing by 50 mL every hour to a maximum of 200; week 2: 500 mL (if there was no reaction), same rates; from week 3: start at 100 mL/h if the previous infusion had no reaction [1].
- Subcutaneous (Faspro): 15 mL into the abdomen, about 7.5 cm to the right or left of the navel, over 3 to 5 minutes; rotate sites; never intravenously [2].
- Premedication (1 to 3 hours before each dose): oral paracetamol 650 to 1000 mg, diphenhydramine 25 to 50 mg, and a corticosteroid: as monotherapy methylprednisolone 100 mg (60 mg may be used after the second dose); in combination regimens dexamethasone 20 mg (the regimen's dexamethasone that day replaces it; do not give the regimen's prednisone on these days) [1, 2].
- After the dose: monotherapy: oral methylprednisolone 20 mg for 2 days starting the next day; combination: consider methylprednisolone ≤20 mg the next day (not needed if the regimen's steroid is given the next day). In COPD, short- and long-acting bronchodilators and inhaled steroids; may be stopped after the first 4 doses without a major reaction [1, 2].
- Herpes zoster prophylaxis: an antiviral within 1 week of starting until 3 months after treatment ends [1, 2].
- Dose modification: no dose reductions are recommended; with neutropenia or thrombocytopenia, delay the dose until recovery. Missed dose: give as soon as possible and adjust the schedule to keep the intervals [1, 2].
- Infusion reaction (intravenous): any grade: stop immediately. Grade 1–2: once resolved, resume at no more than half the previous rate. Grade 3: consider resuming at half the rate; a third grade ≥3 reaction: discontinue permanently. Grade 4: discontinue permanently [1].
- Monitoring: periodic CBC; signs of infection; hepatitis B reactivation (including fatal cases) has been reported in trials [1, 2].
For physicians
Daratumumab dosing schedules (FDA label)
4-week cycle schedule: D-Rd, D-Pd, D-Kd and monotherapy
Newly diagnosed transplant-ineligible myeloma (D-Rd); relapsed or refractory myeloma (D-Rd, D-Pd, D-Kd, monotherapy after ≥3 lines)Cycle length: 28-day cycles
Newly diagnosed transplant-ineligible myeloma (D-Rd); relapsed or refractory myeloma (D-Rd, D-Pd, D-Kd, monotherapy after ≥3 lines)
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 8 | |||
| Daratumumab | 16 mg/kg IV or 1800 mg subcutaneous | IV or subcutaneous | Weekly (8 doses) |
| Weeks 9 to 24 | |||
| Daratumumab | Same dose | Every 2 weeks (8 doses) | |
| From week 25 | |||
| Daratumumab | Same dose | Every 4 weeks until progression | |
D-VMP (6-week cycle)
Newly diagnosed transplant-ineligible myeloma
Newly diagnosed transplant-ineligible myeloma
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 6 | |||
| Daratumumab | 16 mg/kg or 1800 mg | IV or subcutaneous | Weekly (6 doses) |
| Weeks 7 to 54 | |||
| Daratumumab | Same dose | Every 3 weeks (16 doses) | |
| From week 55 | |||
| Daratumumab | Same dose | Every 4 weeks until progression | |
D-VTd or D-VRd for transplant-eligible patients (4-week cycle)
Newly diagnosed transplant-eligible myeloma: induction and consolidation (D-VRd with the subcutaneous form only)Cycle length: 28-day cycles
Newly diagnosed transplant-eligible myeloma: induction and consolidation (D-VRd with the subcutaneous form only)
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Induction: weeks 1 to 8 | |||
| Daratumumab | 16 mg/kg or 1800 mg | IV or subcutaneous | Weekly (8 doses) |
| Induction: weeks 9 to 16 | |||
| Daratumumab | Same dose | Every 2 weeks (4 doses) | |
| Pause | |||
| High-dose chemotherapy and autologous transplant | |||
| Consolidation: weeks 1 to 8 after transplant | |||
| Daratumumab | Same dose | Every 2 weeks (4 doses) | |
D-VRd for transplant-ineligible patients (3-week cycle, subcutaneous)
Newly diagnosed transplant-ineligible myelomaCycle length: 21-day cycles
Newly diagnosed transplant-ineligible myeloma
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 6 | |||
| Daratumumab | 1800 mg | Subcutaneous | Weekly (6 doses) |
| Weeks 7 to 24 | |||
| Daratumumab | 1800 mg | Subcutaneous | Every 3 weeks (6 doses) |
| From week 25 | |||
| Daratumumab | 1800 mg | Subcutaneous | Every 4 weeks until progression |
D-Vd (3-week cycle)
Myeloma after at least 1 line of treatmentCycle length: 21-day cycles
Myeloma after at least 1 line of treatment
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 9 | |||
| Daratumumab | 16 mg/kg or 1800 mg | IV or subcutaneous | Weekly (9 doses) |
| Weeks 10 to 24 | |||
| Daratumumab | Same dose | Every 3 weeks (5 doses) | |
| From week 25 | |||
| Daratumumab | Same dose | Every 4 weeks until progression | |
Subcutaneous daratumumab + teclistamab
Relapsed or refractory myeloma (as per the teclistamab label)Cycle length: As scheduled
Relapsed or refractory myeloma (as per the teclistamab label)
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Day 0, then weekly to week 8; every 2 weeks in weeks 9 to 24; every 4 weeks from week 25 | |||
| Daratumumab | 1800 mg | Subcutaneous | |
| Step-up dosing | |||
| Teclistamab | 0.06 mg/kg (day 1, ≥20 hours after daratumumab), 0.3 mg/kg (day 3), 1.5 mg/kg (day 7) | Subcutaneous | |
| Maintenance | |||
| Teclistamab | 1.5 mg/kg weekly (weeks 2 to 8), then 3 mg/kg every 2 weeks (weeks 9 to 24), then 3 mg/kg every 4 weeks | Subcutaneous | |
The first treatment dose of teclistamab at least 3 hours, and later doses at least 15 minutes, after daratumumab. Manage CRS and ICANS as per the teclistamab label [7].
High-risk smouldering myeloma (monotherapy, subcutaneous)
High-risk smouldering myelomaCycle length: 28-day cycles
High-risk smouldering myeloma
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 8 / 9 to 24 / from 25 | |||
| Daratumumab | 1800 mg | Subcutaneous | Weekly / every 2 weeks / every 4 weeks |
AL amyloidosis: D-VCd (subcutaneous)
Newly diagnosed light-chain amyloidosis; not recommended outside a trial in NYHA IIIB/IV or Mayo stage IIIBCycle length: 28-day cycles
Newly diagnosed light-chain amyloidosis; not recommended outside a trial in NYHA IIIB/IV or Mayo stage IIIB [2]
Before prescribing: Shared safety points| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Weeks 1 to 8 / 9 to 24 / from 25 | |||
| Daratumumab | 1800 mg | Subcutaneous | Weekly / every 2 weeks / every 4 weeks |
| Bortezomib + cyclophosphamide + dexamethasone | As per the drug labels | ||
Monitor patients with cardiac involvement more closely for cardiac adverse reactions [2].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
The most common side effects:
- A reaction during the injection (mostly with the first one): a runny or blocked nose, cough, chills or shortness of breath; this is why medicines are given beforehand [1].
- Cold-like infections, cough and shortness of breath [1, 2].
- Tiredness, diarrhoea, constipation, nausea, swollen legs, fever and back pain [1].
- Numbness and tingling of the hands and feet, and low blood counts; some of these side effects come from the partner drugs [1].
For physicians
Common adverse reactions
In the pooled safety population for the intravenous form (2459 patients), the most common adverse reactions (20% or more) were upper respiratory tract infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhoea, constipation, anaemia, peripheral sensory neuropathy, fatigue, peripheral oedema, nausea, cough, pyrexia, dyspnoea and asthenia [1]. Because daratumumab is usually given with other drugs, some of these reactions come from the partner drugs. The table below shows two examples from the FDA label [1, 2].
| Adverse reaction | MAIA: IV daratumumab + lenalidomide and dexamethasone (364 patients) | AQUILA: subcutaneous daratumumab monotherapy in smouldering myeloma (193 patients) |
|---|---|---|
| Upper respiratory tract infection | 52% [1] | 66% [2] |
| Diarrhoea | 57% [1] | 27% [2] |
| Fatigue | 40% [1] | 42% [2] |
| Infusion- or injection-related reaction | 41% [1] | 17%; local injection-site reaction 20% [2] |
| Oedema | Peripheral oedema 41% [1] | 15% [2] |
| Pneumonia | 26% [1] | 16% [2] |
| Cough | 30% [1] | 19% [2] |
| Dyspnoea | 32% [1] | 18% [2] |
| Sensory neuropathy | 24% [1] | 20% [2] |
| Musculoskeletal pain | Back pain 34% [1] | 59% [2] |
The MAIA adverse reactions include the effects of lenalidomide and dexamethasone. In MAIA, laboratory neutropenia was seen in 91% of patients in the DRd arm [1].
Serious side effects
These are less common but serious; tell your team early if you notice any sign of them:
- A severe reaction during the injection: wheezing, severe shortness of breath, throat swelling or sudden blurred vision; tell the nurse straight away [1, 2].
- Serious infection such as a chest infection: fever, chills or a cough with phlegm [1].
- Hepatitis B becoming active again (rare); your doctor tests for it before and during treatment [1].
- Effect on blood bank tests: for 6 months after the last dose, tell your doctor and the blood bank before any blood transfusion that you have had this drug [1, 2].
For physicians
Daratumumab has no boxed warning, but these important warnings appear in the FDA label [1, 2]:
- Infusion-related and hypersensitivity reactions: can be severe or fatal (bronchospasm, hypoxia, dyspnoea, hypertension, tachycardia, laryngeal oedema). With the intravenous form, 37% of patients had a reaction with the first infusion, 2% with the second and cumulatively 6% with later infusions, and almost all reactions occurred during the infusion or within 4 hours after it [1]. With the subcutaneous form, systemic reactions occurred in 7% of patients (mostly with the first injection) and local injection-site reactions in 8% [2]. Ocular adverse reactions such as acute myopia and angle-closure glaucoma have also been reported [1, 2].
- Interference with blood bank tests: daratumumab binds CD38 on red cells and makes the indirect Coombs test (antibody screening and crossmatch) positive for up to 6 months after the last dose; ABO and Rh typing are not affected [1, 2].
- Serious infections: in the pooled intravenous population, serious infections occurred in 22.6% and fatal infections in 1.2% of patients; pneumonia was the most common [1].
- Hepatitis B reactivation: reported in less than 1% of patients in trials (including fatal cases); monitor before, during and for some time after treatment [1].
- Neutropenia and thrombocytopenia: daratumumab may worsen cytopenias caused by the partner drugs [1, 2].
- Interference with response assessment: as an IgG kappa antibody itself, the drug may be detected on serum protein electrophoresis and immunofixation and interfere with the assessment of complete response in IgG kappa myeloma [1, 2].
- Cardiotoxicity in AL amyloidosis: serious cardiac adverse reactions were reported in 16% and fatal ones in 10% of patients [2].
When should I call my doctor?
- During or after the injection: itching, a runny or blocked nose, chills, nausea, a sore throat, cough, headache, shortness of breath or wheezing, chest pain, or blurred vision or any sudden problem with your eyesight — tell the healthcare staff straight away [1, 2].
- Fever or any sign of infection [1, 2].
- Unusual bruising or bleeding [1, 2].
- Increasing tiredness or yellow skin or whites of the eyes (possible hepatitis B reactivation) [1, 2].
- If you are going to have a blood transfusion, be sure to tell your doctor and the blood bank that you have had daratumumab [1, 2].
Interactions, pregnancy and precautions
- Blood bank: transfusion centres use methods such as treating red cells with DTT or genotyping to get round the drug's interference with compatibility tests, and in an emergency ABO/RhD-compatible blood can be given without a crossmatch [1, 2].
- Drug interactions: the FDA label lists no important clinical drug interactions (of the liver enzyme type) for daratumumab; its important interactions are with laboratory tests. Even so, give your doctor a list of all your medicines, supplements and herbal products [1, 2].
- Chronic obstructive pulmonary disease (COPD): extra inhaled medicines and bronchodilators may be prescribed after the injections [1, 2].
- Pregnancy: daratumumab may harm an unborn baby; women who could become pregnant should use effective contraception for 3 months after the last dose. Its combination with lenalidomide, thalidomide or pomalidomide is forbidden in pregnancy, and the rules of these drugs' REMS programmes must also be followed [1, 2].
- Breastfeeding: breastfeeding is not recommended during treatment [1, 2].
- Newborns: in babies exposed to daratumumab before birth, live vaccines should be postponed until a blood assessment [1, 2].
Frequently asked questions
What is the difference between intravenous and subcutaneous daratumumab?
Both contain the same active ingredient. The subcutaneous form is combined with hyaluronidase and injected under the skin of the abdomen over about 3 to 5 minutes, while the first intravenous infusion takes about 7 hours [1, 2]. Reactions are several times less common with the under-the-skin form than with the drip [1, 2], and in a large study both forms worked equally well [8].
Why do I have to tell the blood bank that I am having daratumumab?
Does a reaction happen with every dose?
How long does daratumumab treatment go on?
Scientific evidence
Show detailsHide
Key studies
4 itemsClinical trial · Phase 3
Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
N Engl J Med · 2024
84.3% vs 67.7%48-month progression-free survival
Clinical trial · Phase 3
Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma
N Engl J Med · 2025
63.1% vs 40.8%5-year progression-free survival
Clinical trial · Phase 3
Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
N Engl J Med · 2026
83.4% vs 29.7%36-month progression-free survival
Clinical trial · Phase 3
Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma
N Engl J Med · 2019
70.6% vs 55.6%30-month progression-free survival
Clinical guidelines
1 itemClinical guideline
International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma
Lancet Oncol · 2014
Related cancer types
Treatment regimens (physicians)
References
8 referencesShow all references, 5 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1DARZALEX (daratumumab) injection, for intravenous use — Prescribing Information
- 2DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use — Prescribing Information
- 3Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma
- 4Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
- 5Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma
- 6Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
- 7
- 8Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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