Darzalex (daratumumab)
Also marketed as Darzalex Faspro. An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Daratumumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Daratumumab
- Brand names
- Darzalex, Darzalex Faspro
- Drug class
- Anti-CD38 monoclonal antibody (CD38-directed cytolytic antibody)
- Manufacturer
- Janssen Biotech (Johnson & Johnson)
- How it's taken
- IV infusion by a healthcare provider, weekly at first, then every 2 to 4 weeks; Darzalex Faspro is a 3 to 5 minute injection under the skin
Darzalex (daratumumab) is an anti-CD38 antibody given by IV infusion to adults with multiple myeloma, both newly diagnosed and relapsed[1].
- The FDA first approved Darzalex on November 16, 2015, under accelerated approval for myeloma after at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent[6][3].
- In the MAIA trial of 737 newly diagnosed adults who could not have a transplant, Darzalex with lenalidomide and dexamethasone lowered the risk of death by 32% (hazard ratio 0.68)[1].
- Darzalex has no boxed warning, and its main label warnings are infusion reactions, infections, low blood counts and interference with blood bank testing[1].
- Darzalex Faspro, the version injected under the skin, has its own label, which adds high-risk smoldering myeloma and AL amyloidosis to its myeloma uses[2].
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Where Daratumumab fits
Darzalex IV is approved only as part of combinations, or alone, for adults with multiple myeloma[1]. Its label uses are: - Newly diagnosed, transplant not an option: with lenalidomide and dexamethasone, or with bortezomib, melphalan and prednisone[1] - Newly diagnosed, transplant eligible: with bortezomib, thalidomide and dexamethasone[1] - After at least 1 prior therapy: with lenalidomide and dexamethasone, or with bortezomib and dexamethasone[1] - After 1 to 3 prior lines: with carfilzomib and dexamethasone[1] - After at least 2 prior therapies including lenalidomide and a proteasome inhibitor: with pomalidomide and dexamethasone[1] - Alone, after at least 3 prior lines including a proteasome inhibitor and an immunomodulatory agent, or when the myeloma no longer responds to both[1] Darzalex Faspro covers these same combinations plus bortezomib, lenalidomide and dexamethasone for newly diagnosed myeloma (transplant eligible or not) and high-risk smoldering myeloma, and its pomalidomide combination starts after 1 prior line rather than 2[2]. Tecvayli is also approved with Darzalex Faspro after at least 1 prior line that included a proteasome inhibitor and an immunomodulatory agent[12].
How Daratumumab works
Darzalex is a monoclonal antibody, a lab-made immune protein designed to stick to one target[1]. Its target is CD38, a protein on the surface of myeloma cells and some other blood-forming cells[1].
Once Darzalex attaches to CD38, the label describes several ways the myeloma cell can be killed[1]:
CD38 is also found on red blood cells, which is why Darzalex can interfere with blood bank tests used to match blood for a transfusion[1]. Darzalex Faspro contains the same antibody plus hyaluronidase, an enzyme that lets a larger volume be absorbed under the skin[2].
Side effects and safety
- Infusion-related reactions. 37% with the first infusion, 2% with the second and 6% cumulatively after that; can be severe or fatal, and eye reactions such as acute myopia and angle-closure glaucoma have occurred.
- Interference with blood bank testing. Causes a positive indirect Coombs test that can last up to 6 months after the last dose; blood type and screen is done before starting, and blood banks should be told.
- Infections. Serious infections in 22.6% and fatal infections in 1.2% in a pooled group of 2,066 people, most often pneumonia.
- Neutropenia. Can deepen low white blood cell counts caused by the other medicines in the combination; doses may be held until counts recover.
- Thrombocytopenia. Can deepen low platelet counts caused by the other medicines in the combination; doses may be held until counts recover.
- Interference with response testing. Darzalex can show up on protein electrophoresis and immunofixation tests, which can affect how a complete response is judged in IgG kappa myeloma.
- Embryo-fetal toxicity. May harm an unborn baby; effective birth control during treatment and for 3 months after the last dose.
- Blood type and antibody screen before the first dose
- Close watching during the whole infusion for infusion reactions
- Complete blood counts during treatment
- Signs of infection before and during treatment
- Eye symptoms during infusions, with an eye exam if they appear
Darzalex IV does not carry a boxed warning[1]. The main safety issue is infusion-related reactions, which happened in 37% of people with the first infusion, 2% with the second and 6% cumulatively with later infusions[1]. Nearly all happened during the infusion or within 4 hours after it, and reactions can be severe, life-threatening or fatal[1]. Eye problems such as sudden nearsightedness and a type of glaucoma have also occurred during infusions[1].
Other warnings on the current label:
- Infections: in a pooled group of 2,066 people, serious infections occurred in 22.6% and fatal infections in 1.2%, most often pneumonia[1]
- Low white blood cells (neutropenia) and low platelets (thrombocytopenia), which Darzalex can make worse on top of the other medicines in the combination[1]
- Blood bank interference: Darzalex causes a positive indirect Coombs test that can last up to 6 months after the last infusion, although ABO and Rh blood typing are not affected[1]
- Interference with the protein tests used to confirm a complete response in some people with IgG kappa myeloma[1]
- Possible harm to an unborn baby, with birth control advised during treatment and for 3 months after the last dose[1]
The most common side effects (in 20% or more) across trials were upper respiratory infection, low neutrophils, infusion reactions, low platelets, diarrhea, constipation, anemia, nerve tingling or numbness, tiredness, swelling in the legs, nausea, cough, fever, shortness of breath and weakness[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Daratumumab
Darzalex IV is given as an infusion into a vein by a healthcare provider, with emergency equipment nearby[1]. The dose is 16mg/kg of actual body weight, and the first dose may be split over 2 days as 8mg/kg each day[1].
How long infusions take, per the label:
With lenalidomide, pomalidomide or carfilzomib combinations, or used alone, Darzalex is given weekly in weeks 1 to 8, every 2 weeks in weeks 9 to 24, and every 4 weeks from week 25 until the myeloma worsens[1]. With carfilzomib, the week 1 dose is always split as 8mg/kg on 2 days in a row[1]. The schedule differs with bortezomib-based combinations, and before and after a stem cell transplant with bortezomib, thalidomide and dexamethasone[1].
Before every infusion, people get a corticosteroid, acetaminophen and an antihistamine 1 to 3 hours ahead to lower the risk of reactions, and an oral steroid is given after infusions to reduce delayed reactions[1]. Darzalex has no REMS program[1].
Darzalex Faspro is a fixed dose of 1,800mg daratumumab with 30,000 units of hyaluronidase, injected under the skin of the abdomen over about 3 to 5 minutes[2].
Availability and cost
Only available as the brand-name product.
Help paying for Darzalex
With private insurance, the drugmaker's copay card can lower what you pay for Darzalex. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. Without insurance, you can apply to the drugmaker's free medicine program, which sets its own eligibility rules. Pick your insurance below to see which offers fit you.
- Copay help
Eligible commercially insured patients may pay as little as $5 per dose for Darzalex or Darzalex Faspro through the J&J withMe Savings Program. A maximum program benefit per calendar year applies, and the program does not cover the cost of giving the treatment.
For: private insurance · source - Insurance and case manager help
A dedicated Care Navigator helps explain insurance coverage and out-of-pocket costs, points to state programs, Medicare Savings Program, Medicaid and independent foundations, and connects people to transportation services. Call 833-565-9631, Monday through Friday, 8:00 AM to 8:00 PM ET.
For: private insurance, Medicare, Medicaid, no insurance · source - Free medicine program
The Johnson & Johnson Patient Assistance Program may provide treatment at no cost for up to 1 year to uninsured people who meet its eligibility and income rules. Call 833-742-0791 or see PatientAssistanceInfo.com.
For: no insurance, underinsured · source
Good to know: Darzalex withMe is free for people 18 or older prescribed Darzalex or Darzalex Faspro for an approved use. The savings program does not require sharing income information, and the offer can change or end without notice. The savings program is for commercial insurance; people with Medicare, Medicaid or military coverage get help finding other options.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
Darzalex IV myeloma uses rest on several randomized trials, each reported in the label's Clinical Studies section[1].
Newly diagnosed myeloma:
- MAIA (NCT02252172), 737 people who could not have a transplant: Darzalex with lenalidomide and dexamethasone versus lenalidomide and dexamethasone; at the first analysis the progression-free survival hazard ratio was 0.56, and at a median follow-up of 64 months median progression-free survival was 61.9 versus 34.4 months; the overall survival hazard ratio was 0.68 at a median follow-up of 56 months, and after 89 months median overall survival was 90.3 versus 64.1 months[1][9]
- ALCYONE (NCT02195479), 706 people who could not have a transplant: adding Darzalex to bortezomib, melphalan and prednisone gave a progression-free survival hazard ratio of 0.50 and an overall survival hazard ratio of 0.60[1]
- CASSIOPEIA (NCT02541383), 1,085 people aged 65 or younger eligible for transplant: adding Darzalex to bortezomib, thalidomide and dexamethasone raised the stringent complete response rate at day 100 after transplant from 20.3% to 28.9%[1]
Relapsed or refractory myeloma:
- POLLUX (NCT02076009), 569 people: Darzalex with lenalidomide and dexamethasone had median progression-free survival of 45.0 versus 17.5 months, and median overall survival of 67.6 versus 51.8 months[1]
- CASTOR (NCT02136134), 498 people: Darzalex with bortezomib and dexamethasone had median progression-free survival of 16.7 versus 7.1 months[1]
- CANDOR (NCT03158688), 466 people: Darzalex with carfilzomib and dexamethasone had a progression-free survival hazard ratio of 0.63[1]
- SIRIUS (NCT01985126), 106 people after at least 3 prior lines: 29.2% responded to Darzalex alone[1]
- COLUMBA (NCT03277105), 522 people after at least 3 prior lines: Darzalex Faspro under the skin against IV Darzalex, with 41% versus 37% responding, which met the goal of being no worse, and median progression-free survival of 5.6 versus 6.1 months[2]
The MAIA overall survival result was also published in a peer-reviewed paper[10].
Development history
The FDA first approved Darzalex IV on November 16, 2015, under accelerated approval, for myeloma after at least 3 prior lines including a proteasome inhibitor and an immunomodulatory agent, or myeloma that no longer responded to both[6]. The current label lists that use without an accelerated approval note[1].
Later myeloma approvals for Darzalex IV, by date from Drugs@FDA[3]:
- November 21, 2016: with lenalidomide and dexamethasone, and with bortezomib and dexamethasone, after at least 1 prior therapy[3][1]
- June 16, 2017: with pomalidomide and dexamethasone after at least 2 prior therapies[3][1]
- May 7, 2018: with bortezomib, melphalan and prednisone for newly diagnosed myeloma when a transplant is not an option[3][1]
- June 27, 2019: with lenalidomide and dexamethasone for newly diagnosed myeloma when a transplant is not an option[3][1]
- September 26, 2019: with bortezomib, thalidomide and dexamethasone for newly diagnosed myeloma before and after a transplant[3][1]
- August 20, 2020: with carfilzomib and dexamethasone after 1 to 3 prior lines, based on CANDOR[4][1]
The under-the-skin version, Darzalex Faspro, was first approved on May 1, 2020[5]. Its label later added high-risk smoldering myeloma on November 6, 2025, and the 4-drug combination with bortezomib, lenalidomide and dexamethasone for newly diagnosed people who cannot have a transplant on January 27, 2026, after an earlier complete response letter dated July 30, 2025[7][8].
Darzalex Faspro is also approved for newly diagnosed AL amyloidosis, covered on its own page at [/drugs/daratumumab-hyaluronidase](/drugs/daratumumab-hyaluronidase)[2].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Darzalex and Sarclisa (isatuximab) are the 2 FDA-approved anti-CD38 antibodies for myeloma, and both are given with other myeloma medicines[1][11]. No trial has compared Darzalex with Sarclisa directly. Many newer myeloma medicines target a different protein, BCMA, including the CAR-T therapies Abecma and Carvykti and the bispecific antibodies Tecvayli, Elrexfio and Lynozyfic, and several of their labels are for people whose myeloma has already been treated with an anti-CD38 antibody[12][13].
Common questions about Daratumumab
▸What is Daratumumab (Darzalex)?
Darzalex (daratumumab) is an anti-CD38 antibody given by IV infusion to adults with multiple myeloma, both newly diagnosed and relapsed[1]. The FDA first approved Darzalex on November 16, 2015, under accelerated approval for myeloma after at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent[6][3]. In the MAIA trial of 737 newly diagnosed adults who could not have a transplant, Darzalex with lenalidomide and dexamethasone lowered the risk of death by 32% (hazard ratio 0.68)[1]. Darzalex has no boxed warning, and its main label warnings are infusion reactions, infections, low blood counts and interference with blood bank testing[1]. Darzalex Faspro, the version injected under the skin, has its own label, which adds high-risk smoldering myeloma and AL amyloidosis to its myeloma uses[2].
▸How does Daratumumab work?
Darzalex is a monoclonal antibody, a lab-made immune protein designed to stick to one target[1]. Its target is CD38, a protein on the surface of myeloma cells and some other blood-forming cells[1].
Once Darzalex attaches to CD38, the label describes several ways the myeloma cell can be killed[1]:
- Immune cells are drawn in to destroy it, a process called antibody-dependent cell-mediated cytotoxicity[1]
- Complement, a group of blood proteins, punches holes in the cell[1]
- Immune cells called macrophages swallow it[1]
- Some cells are pushed into programmed cell death[1]
CD38 is also found on red blood cells, which is why Darzalex can interfere with blood bank tests used to match blood for a transfusion[1]. Darzalex Faspro contains the same antibody plus hyaluronidase, an enzyme that lets a larger volume be absorbed under the skin[2].
▸What are the side effects of Daratumumab?
Darzalex IV does not carry a boxed warning[1]. The main safety issue is infusion-related reactions, which happened in 37% of people with the first infusion, 2% with the second and 6% cumulatively with later infusions[1]. Nearly all happened during the infusion or within 4 hours after it, and reactions can be severe, life-threatening or fatal[1]. Eye problems such as sudden nearsightedness and a type of glaucoma have also occurred during infusions[1].
Other warnings on the current label: Infections: in a pooled group of 2,066 people, serious infections occurred in 22.6% and fatal infections in 1.2%, most often pneumonia[1] Low white blood cells (neutropenia) and low platelets (thrombocytopenia), which Darzalex can make worse on top of the other medicines in the combination[1] Blood bank interference: Darzalex causes a positive indirect Coombs test that can last up to 6 months after the last infusion, although ABO and Rh blood typing are not affected[1] Interference with the protein tests used to confirm a complete response in some people with IgG kappa myeloma[1] Possible harm to an unborn baby, with birth control advised during treatment and for 3 months after the last dose[1]
The most common side effects (in 20% or more) across trials were upper respiratory infection, low neutrophils, infusion reactions, low platelets, diarrhea, constipation, anemia, nerve tingling or numbness, tiredness, swelling in the legs, nausea, cough, fever, shortness of breath and weakness[1].
▸How is Daratumumab taken?
Darzalex IV is given as an infusion into a vein by a healthcare provider, with emergency equipment nearby[1]. The dose is 16mg/kg of actual body weight, and the first dose may be split over 2 days as 8mg/kg each day[1].
How long infusions take, per the label:
- About 7 hours for the first infusion[1]
- About 4 hours for the second infusion[1]
- About 3 hours for later infusions[1]
With lenalidomide, pomalidomide or carfilzomib combinations, or used alone, Darzalex is given weekly in weeks 1 to 8, every 2 weeks in weeks 9 to 24, and every 4 weeks from week 25 until the myeloma worsens[1]. With carfilzomib, the week 1 dose is always split as 8mg/kg on 2 days in a row[1]. The schedule differs with bortezomib-based combinations, and before and after a stem cell transplant with bortezomib, thalidomide and dexamethasone[1].
Before every infusion, people get a corticosteroid, acetaminophen and an antihistamine 1 to 3 hours ahead to lower the risk of reactions, and an oral steroid is given after infusions to reduce delayed reactions[1]. Darzalex has no REMS program[1].
Darzalex Faspro is a fixed dose of 1,800mg daratumumab with 30,000 units of hyaluronidase, injected under the skin of the abdomen over about 3 to 5 minutes[2].
▸Is Daratumumab FDA approved?
Yes, Daratumumab (Darzalex) is FDA approved (2015) for the treatment of Multiple Myeloma.
▸How long does a Darzalex infusion take?
The first Darzalex IV infusion takes about 7 hours, according to the median times on the label[1].
Second infusion: About 4 hours[1].
Later infusions: About 3 hours[1].
Split option: The first dose can be split over 2 days as 8mg/kg each day[1].
Faspro: Darzalex Faspro is injected under the skin over about 3 to 5 minutes[2].
Source: Darzalex and Darzalex Faspro prescribing information (DailyMed)
▸What is the difference between Darzalex and Darzalex Faspro?
Both contain the same antibody, daratumumab, but Darzalex is an IV infusion and Darzalex Faspro is an injection under the skin[1][2].
Dose: Darzalex IV is 16mg/kg by body weight; Darzalex Faspro is a fixed 1,800mg dose with hyaluronidase[1][2].
Uses: Darzalex Faspro's label also covers high-risk smoldering myeloma, a 4-drug combination with bortezomib, lenalidomide and dexamethasone, and AL amyloidosis[2].
Comparison: Trial Friend does not rank one over the other; which one fits is a question for the care team.
Source: Darzalex and Darzalex Faspro prescribing information (DailyMed)
▸Does Darzalex affect blood transfusions?
Yes, Darzalex can make blood bank antibody screening tests come back positive, which can delay matching blood for a transfusion[1].
How long: The positive indirect Coombs test may last up to 6 months after the last infusion[1].
Not affected: ABO and Rh blood typing still work normally[1].
What the label advises: A blood type and screen before starting, and telling the blood bank about Darzalex treatment[1].
Source: Darzalex prescribing information (DailyMed)
▸Is Darzalex chemotherapy?
The Darzalex label describes it as a CD38-directed cytolytic antibody, a type of monoclonal antibody rather than a traditional chemotherapy drug[1].
How it works: It attaches to CD38 on myeloma cells and helps the immune system destroy them[1].
Combinations: Several approved Darzalex regimens include other medicines, such as melphalan, which works differently[1].
Source: Darzalex prescribing information (DailyMed)
▸How much does Darzalex cost?
A list price is not stated on the label, and Trial Friend does not publish a price it cannot confirm.
Savings: Johnson & Johnson says eligible commercially insured patients may pay as little as $5 per dose, with a yearly maximum, and the program does not cover the cost of giving the treatment[14].
No insurance: J&J says uninsured people who meet its rules may get the medicine at no cost for up to 1 year through its Patient Assistance Program[14].
Source: Darzalex Savings and Support page (Johnson & Johnson)
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-09. DARZALEX (daratumumab) injection, for intravenous use, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-09. DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0
- U.S. Food and Drug Administration · 2026-05-28. Drugs@FDA: DARZALEX, BLA 761036, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761036
- U.S. Food and Drug Administration · 2020-08-20. BLA 761036/S-029 supplement approval: Darzalex with carfilzomib and dexamethasone after 1 to 3 prior lines. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761036Orig1s029ltr.pdf
- U.S. Food and Drug Administration · 2026-02-12. Drugs@FDA: DARZALEX FASPRO, BLA 761145, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761145
- U.S. Food and Drug Administration · 2015-11-16. BLA 761036 accelerated approval letter, Darzalex (daratumumab). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761036Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2025-11-06. BLA 761145/S-029 supplement approval: high-risk smoldering multiple myeloma. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s029ltr.pdf
- U.S. Food and Drug Administration · 2026-01-27. BLA 761145/S-028 supplement approval: with bortezomib, lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761145Orig1s028ltr.pdf
- ClinicalTrials.gov · 2026-11. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma (MAIA). https://clinicaltrials.gov/study/NCT02252172
- The Lancet Oncology · 2021-11. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. https://doi.org/10.1016/S1470-2045(21)00466-6
- U.S. National Library of Medicine, DailyMed (sanofi-aventis U.S. LLC) · 2026-07. SARCLISA (isatuximab-irfc) injection, for intravenous use, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0473462-6f9d-4eca-a5bf-8620aea68e8a
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-03. TECVAYLI (teclistamab-cqyv) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e
- U.S. National Library of Medicine, DailyMed (Regeneron Pharmaceuticals) · 2025-07. LYNOZYFIC (linvoseltamab-gcpt) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9fd0739-1b3f-4b8b-824a-1f0a902384d3
- Johnson & Johnson · 2026-11. Savings and Support, DARZALEX withMe. https://www.darzalex.com/savings-support/