Daratumumab

Pronunciation: dar-a-TOOM-yoo-mab.

Generic name
daratumumab
Drug class
CD38-directed monoclonal antibody
Form
Subcutaneous injection (1,800 mg/30,000 units) or IV concentrate for infusion
Route
Subcutaneous injection (Darzalex Faspro) or intravenous infusion (original Darzalex)
Legal status
Prescription-only, specialist-initiated (oncology/haematology, given at an infusion/injection centre)

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Darzalex / Darzalex SC (4) · Full directory

What daratumumab is and how it works

Daratumumab is a prescription-only cancer medicine (a monoclonal antibody) used to treat multiple myeloma and a related condition called AL amyloidosis. It targets a protein called CD38 found on myeloma cells. (1)

Daratumumab is given by injection under the skin or by IV infusion at a cancer treatment centre, always alongside other required medicines given before and after each dose to reduce the risk of a reaction. It is prescribed and monitored throughout by a cancer specialist.

Mechanism of action: how daratumumab works

Daratumumab is a human IgG1 kappa monoclonal antibody targeting CD38, a protein highly expressed on multiple myeloma cells, triggering immune-mediated destruction of these cells. (1)

What daratumumab is used for

Multiple myeloma

Used, often together with other cancer medicines, to treat multiple myeloma -- both in people newly diagnosed (whether or not they are having a stem cell transplant) and in people whose myeloma has come back or not responded to previous treatment. Also used alone for high-risk smoldering multiple myeloma and for people who have already tried several other treatments. (1)

Light chain (AL) amyloidosis

Used together with bortezomib, cyclophosphamide, and dexamethasone to treat AL amyloidosis, a condition where abnormal proteins build up in organs. Not generally recommended for people with advanced heart involvement from this condition outside of a clinical trial. (1)

Before taking daratumumab

Do not take / not appropriate for

  • Do not use daratumumab if you have had a severe allergic reaction to daratumumab, hyaluronidase, or any ingredient in the product. (all countries) (1)

Tell your clinician about

  • Any previous reaction to daratumumab or a similar cancer antibody medicine.
  • Any history of shingles (herpes zoster) or chickenpox.
  • Any eye problems.
  • Any low blood cell counts.
  • Whether you have ever needed a blood transfusion, and let any future blood bank know you have had this medicine.
  • Pregnancy, plans for pregnancy, or breastfeeding, and any other cancer medicines you are taking (some combinations are not safe in pregnancy).
(1)

How to take daratumumab

  • Daratumumab is given by a healthcare professional, either as an injection under the skin of the abdomen or as an IV infusion -- never self-injected without direct medical supervision.
  • You will be given other medicines before each dose (usually a painkiller, an antihistamine, and a steroid) and, in some cases, after each dose, to reduce the risk of a reaction.
  • You will usually also be prescribed an antiviral medicine to prevent shingles, starting within a week of your first dose and continuing for 3 months after your last dose.
  • How often you receive daratumumab changes over the course of treatment -- often weekly at first, then less frequently as treatment continues.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

If a dose is missed, your treatment team will give it as soon as possible and adjust your schedule to keep your doses at the right interval. This is managed entirely by your care team, not something to arrange yourself.

Overdose

Daratumumab is given under direct medical supervision, so overdose is managed by the treating team at the time of administration. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Upper respiratory infections (colds, sinus infections) are very common.

What to notice: Upper respiratory infections (colds, sinus infections) are very common.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Tiredness, muscle or joint pain, diarrhoea or constipation, sleep problems, and rash.

What to notice: Tiredness, muscle or joint pain, diarrhoea or constipation, sleep problems, and rash.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Numbness or tingling (peripheral neuropathy), swelling (oedema), fever, and cough, particularly in combination regimens.

What to notice: Numbness or tingling (peripheral neuropathy), swelling (oedema), fever, and cough, particularly in combination regimens.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Blood test changes: lower white blood cells, platelets, and red blood cells are common and are monitored throughout treatment.

What to notice: Blood test changes: lower white blood cells, platelets, and red blood cells are common and are monitored throughout treatment.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of a reaction during or shortly after an injection or infusion — emergency

Symptoms: Difficulty breathing, wheezing, chest tightness, a fast heartbeat, high blood pressure, or eye symptoms such as pain, redness, or vision changes.

Action: Tell the treatment team immediately -- reactions are monitored closely during and after each dose. Any eye symptoms need an eye specialist's assessment before another dose is given. Severe, life-threatening reactions mean daratumumab must be permanently stopped. (1)

Signs of low blood counts — high caution

Symptoms: Unusual bruising or bleeding, frequent infections, or extreme tiredness.

Action: Your specialist will check your blood counts regularly and may delay a dose until your counts recover. (1)

Signs of shingles (herpes zoster) — high caution

Symptoms: A painful, blistering rash, often in a band on one side of the body.

Action: Tell your treatment team promptly -- this is why an antiviral preventive medicine is usually prescribed alongside daratumumab. (1)

Interactions

  • Daratumumab can cause a false-positive result on certain blood compatibility tests (used before a blood transfusion) for up to 6 months after your last dose -- always tell any blood bank or hospital that you have had this medicine. (1)
  • Daratumumab can interfere with certain blood tests used to monitor myeloma treatment response (protein electrophoresis) -- your specialist is aware of this and accounts for it when interpreting your results. (1)
  • Combining daratumumab with lenalidomide, thalidomide, or pomalidomide is not safe during pregnancy because of those medicines' own risks -- effective contraception is required. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Daratumumab can harm an unborn baby, including effects on the baby's immune cells and bone development. Effective contraception is required during treatment and for 3 months after the last dose. Some combination regimens (with lenalidomide, thalidomide, or pomalidomide) must not be used in pregnancy at all. (1) (2) (3) (4) (5)

Breastfeeding

Not established in the source reviewed for this dossier; discuss with your specialist given the medicine's other pregnancy-related risks. (1) (2) (3) (4) (5)

Children

Not established as safe/effective in children in the source reviewed. (1) (2) (3) (4) (5)

Elderly

No specific dose adjustment based on age alone is described in the source reviewed. (1) (2) (3) (4) (5)

Hepatic_impairment

Not established in the source reviewed for this dossier. (1) (2) (3) (4) (5)

Renal_impairment

Not established in the source reviewed for this dossier. (1) (2) (3) (4) (5)

Monitoring

Before starting

  • Full blood count
  • Blood type and antibody screen (before the interference from this medicine begins)
  • Screening for shingles/chickenpox history

During treatment

  • Regular full blood counts.
  • Close monitoring during and immediately after each dose for reaction symptoms, including eye symptoms.
  • Ongoing monitoring for infection, particularly shingles.
(1)

Storage

Daratumumab is stored and prepared by the treatment centre; patients do not typically store or handle it themselves.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: Multiple myeloma / AL amyloidosis (regimen-dependent)

Dose summary: Darzalex Faspro: 1,800 mg daratumumab + 30,000 units hyaluronidase SC, abdomen, over ~3-5 min. Typical schedule weekly (weeks 1-8), every 2-3 weeks (weeks 9-24, regimen-dependent), every 4 weeks (week 25+) until progression. Mandatory pre-medication (acetaminophen, diphenhydramine, corticosteroid) and post-medication per regimen; herpes zoster antiviral prophylaxis from week 1 through 3 months post-treatment.

Renal context: Not established in the source reviewed for this dossier. (1)

Mechanism of action

Hepatic guidance

Not established in the source reviewed for this dossier.

Overdose note

Administered under direct medical supervision at every dose; no self-administered overdose scenario applies. (1)

Frequently asked questions

Is Darzalex (daratumumab) available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is approved and available in the US, UK, EU, and Australia. Canadian approval is referenced in available sources but not fully confirmed against a primary register in this review. New Zealand's status is genuinely (1) (2) (3) (4) (5)

Why do I need to carry a card after taking daratumumab?

Daratumumab can cause a false-positive result on certain blood compatibility tests for up to 6 months after your last dose. Carrying a card and telling any blood bank or hospital that you've had this medicine helps them interpret your test results correctly if you ever need a blood transfusion. (1)

Why do I need other medicines before and after each Darzalex dose?

Your care team gives pre-medications (a pain reliever, an antihistamine, and a corticosteroid) 1 to 3 hours before each dose to reduce the chance and severity of an infusion/injection-related reaction, which can occur especially with the first couple of doses. Some regimens also require a follow-up corticosteroid the day after, and antiviral medicine to prevent shingles reactivation, continuing for 3 months after treatment ends. (1)

What is the mechanism of action of daratumumab?

Daratumumab is a human IgG1 kappa monoclonal antibody targeting CD38, a protein highly expressed on multiple myeloma cells, triggering immune-mediated destruction of these cells. (1)

What is the generic name of Daratumumab?

The generic name is daratumumab. (1)

What class of drug is daratumumab?

Daratumumab is classed as: CD38-directed monoclonal antibody. (1)

References

  1. DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Janssen Biotech, Inc. · United States · accessed 2026-07-29 · source 1
  2. European Commission approval history for Darzalex (daratumumab)Johnson & Johnson / Janssen corporate press releases · European Union · accessed 2026-07-29 · source 2
  3. Darzalex 1800mg solution for injection -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Janssen-Cilag Ltd · United Kingdom · accessed 2026-07-29 · source 3
  4. DARZALEX / DARZALEX SC -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 4
  5. Health Canada approval of daratumumab subcutaneous formulationHealth Canada (via secondary search summary) · Canada · accessed 2026-07-29 · source 5

Brand names by country

Single-ingredient daratumumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • DARZALEX100 mg/5mL · janssen biotech, inc.
  • Darzalex IV100 mg/5mL · janssen biotech, inc.

United Kingdom

  • Darzalex (3)MHRA licensed emc smpc confirmed · 1800 mg SC, 20 mg/mL IV concentrate · Janssen-Cilag Ltd

Canada

  • DARZALEX

Australia

  • Darzalex / Darzalex SC (4)TGA ARTG registered 2017-07-17 · 100 mg/5 mL, 400 mg/20 mL · Janssen-Cilag Pty Ltd
View brands in additional countries.

European Union

Darzalex (2)

This page provides general reference information about daratumumab (Darzalex/Darzalex Faspro) and is not a substitute for advice from the cancer specialist managing your treatment. All dosing, scheduling, and treatment decisions should be made with your specialist care team.

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