Daratumumab – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 28 min read
Daratumumab - Uses, Dosage, Side Effects, Interaction
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Article Summary

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light-chain amyloidosis. Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab.[rx] It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.[rx] Daratumumab, sold under the brand name Darzalex,...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
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Definition

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of and light-chain amyloidosis. Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab.[rx] It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple cells; the first of its kind.[rx]

Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38,[rx] which is overexpressed in multiple myeloma cells.[rx] Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.[rx]

Daratumumab was granted FDA approval on 16 November 2015.[rx] It is approved for the treatment of multiple myeloma as monotherapy or combination therapy and light chain (AL) amyloidosis in combination with other drugs.[rx,rx]

Mechanism of action

CD38 is a glycoprotein present on the surface of hematopoietic cells and is responsible for a number of cell signaling functions. Daratumumab is an immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that targets CD38.[rx] Cancers like multiple myeloma overexpress CD38, allowing daratumumab to have a higher affinity for these cells.[rx] This binding allows daratumumab to induce apoptosis, antibody-dependent cellular phagocytosis, and antibody and complement-dependent cytotoxicity.[rx] Antibody-dependent cellular phagocytosis is mediated by the FC region of the antibody-inducing phagocytes such as macrophages, antibody-dependent cellular cytotoxicity is mediated by the FC region of the antibody-inducing effector cells such as natural killer cells, and complement dependent cytotoxicity is mediated by the FC region of the antibody binding to and inducing complement protein activity.[rx]

Daratumumab is a monoclonal antibody that targets and induces apoptosis in cells that highly express CD38, including multiple myeloma cells.[rx,rx] It has a long duration of action as it is given every 1-4 weeks.[rx,rx] Patients should be counseled regarding the risk of hypersensitivity, , , embryo-fetal toxicity, and interferences with cross-matching and red blood cell antibody .[rx]

Indications

  • Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma.[rx] It is available as a combination product with hyaluronidase for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs.[rx]
  • Light-Chain Amyloidosis
  • Multiple Myeloma (MM)
  • Multiple Myeloma
  • Relapsed Multiple Myeloma

Use in Cancer

Daratumumab is approved to be used alone or with other drugs to treat:

  • Multiple myeloma. It is used:
    • In adults with newly diagnosed diseases. It is used:
    • In adults with relapsed or refractory disease. It is used:
      • With dexamethasone and bortezomib in patients who have received at least one therapy.
      • With dexamethasone and carfilzomib in patients who have received one to three other types of therapy.
      • With pomalidomide and dexamethasone in patients who have received at least two therapies that included lenalidomide and a proteasome inhibitor.
      • Alone in patients who have received at least three types of therapy that included a proteasome inhibitor and an immunomodulating agent or whose disease is refractory to both a proteasome inhibitor and an immunomodulatory agent.

Daratumumab is also available in a different form, combined with hyaluronidase. For more information, see the Drug Information Summary for Daratumumab and hyaluronidase-fihj.

Daratumumab is also being studied in the treatment of other types of cancer.

Contraindications

  • decreased blood platelets
  • low levels of a type of white blood cell called neutrophils
  • pregnancy
  • reactivation of B

Strengths: 20 mg/mL

Multiple Myeloma

DOSING SCHEDULE IN COMBINATION WITH LENALIDOMIDE OR POMALIDOMIDE (4-WEEK CYCLE) AND LOW-DOSE DEXAMETHASONE AND FOR MONOTHERAPY:

  • Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses)
  • Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); the first dose of the every-2-week dosing schedule is given at Week 9
  • Week 25 and onwards until : 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25

DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB, MELPHALAN, AND PREDNISONE 6-WEEK CYCLE:

  • Weeks 1 to 6: 16 mg/kg IV weekly (total of 6 doses)
  • Weeks 7 to 54: 16 mg/kg IV every 3 weeks (total of 16 doses); the first dose of the every-3-week dosing schedule is given at Week 7
  • Week 55 onwards until disease : 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 55

DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB, THALIDOMIDE, AND DEXAMETHASONE 4-WEEK CYCLE:
INDUCTION:

  • Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses)
  • Weeks 9 to 16: 16 mg/kg IV every 2 weeks (total of 4 doses); the first dose of every-2-week dosing schedule is given at Week 9
  • Stop high-dose and ASCT.

CONSOLIDATION:

  • Weeks 1 to 8: 16 mg/kg IV every 2 weeks; the first dose of the every-2-week dosing schedule is given at Week 1 upon reinitiation of therapy following ASCT

DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE 3-WEEK CYCLE:

  • Weeks 1 to 9: 16 mg/kg IV weekly (total of 9 doses)
  • Weeks 10 to 24: 16 mg/kg IV every 3 weeks (total of 5 doses); the first dose of every-3-week dosing schedule is given at Week 10
  • Week 25 onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25

DOSING SCHEDULE WITH CARFILZOMIB AND DEXAMETHASONE 4-WEEK CYCLE:

  • Week 1: 8 mg/kg IV on Days 1 and 2 (total of 2 doses)
  • Weeks 2 to 8: 16 mg/kg IV weekly (total of 7 doses)
  • Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); the first dose of the every-2-week dosing schedule is given at Week 9
  • Week 25 onwards until disease progression: 16 mg/kg every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25
  • Dosing is based on actual body weight.
  • The first 16 mg/kg dose at Week 1 may be split over 2 consecutive days (i.e., 8 mg/kg on Day 1 and Day 2, respectively.
  • Pre-and post-infusion medications should be given prior to initiating therapy.

Manufacturer-recommended infusion rates and management of infusion-related reactions (IRRs):
OPTION 1 (SINGLE DOSE INFUSION):
Week 1 Day 1 (16 mg/kg):

  • Dilution volume: 1000 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

OPTION 2 (SPLIT DOSE INFUSION):
Week 1 Day 1 (8 mg/kg):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

Week 1 Day 2 (8 mg/kg):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

WEEK 2 (16 mg/kg):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

WEEK 3 ONWARDS (16 MG/KG):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 100 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr
  • Consider incremental escalation of the infusion rate only in the absence of infusion reactions.
  • Use a dilution volume of 500 mL for the 16 mg/kg dose only if there were no infusion reactions the previous week; otherwise, continue to use a dilution volume of 1000 mL.
  • Use a modified initial rate (100 mL/hour) for subsequent infusions (i.e., Week 3 onwards) only if there were no infusion reactions during the previous infusion; otherwise, continue to use instructions indicated for the Week 2 infusion rate.

PREMEDICATIONS:
Premedicate approximately 1 to 3 hours prior to every infusion:
1) Corticosteroid (long- or intermediate-acting);

  • Monotherapy: Methylprednisolone (or equivalent) 100 mg IV; following the second infusion, consider reducing the dose to 60 mg (or equivalent) IV or orally.
  • Combination therapy: Administer 20 mg dexamethasone (or equivalent) IV or orally. When dexamethasone is the background regimen specific corticosteroid, the dexamethasone dose that is part of the background regimen will serve as premedication on daratumumab infusion days.
  • Do not administer background regimen-specific corticosteroids (e.g., prednisone) on daratumumab infusion day.
  • Daratumumab infusion days when patients have received dexamethasone (or equivalent) as a premedication.

2) Antipyretic: Acetaminophen 650 to 1000 mg orally
3) Antihistamine: Diphenhydramine (or equivalent) 25 to 50 mg IV or orally

POST-INFUSION MEDICATION:

  • MONOTHERAPY: Administer methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of daratumumab.
  • IN COMBINATION: Consider administering oral methylprednisolone at a dose of less than or equal to 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) beginning the day after the administration of daratumumab.
    If a background regimen-specific corticosteroid (e.g., dexamethasone, prednisone) is administered the day after the daratumumab infusion, additional corticosteroids may not be needed.
  • For patients with a history of , consider prescribing short and long-acting bronchodilators and inhaled corticosteroids. Following the first 4 daratumumab infusions, consider discontinuing these additional post-infusion medications if the patient does not experience a major infusion-related reaction.

PROPHYLAXIS FOR HERPES ZOSTER REACTIVATION:

  • Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting daratumumab and continue for 3 months after.
  • For dosing instructions of combination agents administered with this drug see the manufacturer product information.
  • In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant or with relapsed or refractory multiple myeloma who have received at least 1 prior therapy
  • In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT)
  • In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
  • In combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy
  • In combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
  • As monotherapy, in patients who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

Dose Adjustments

  • No dose reductions of daratumumab are recommended. Consider withholding therapy to allow recovery of blood cell counts in the event of myelosuppression.

INFUSION-RELATED REACTIONS (IRRs):
For infusion-related reactions (IRRs) of any grade/severity, interrupt the infusion and manage symptoms (this may require further reduction in the rate of infusion or discontinuation of therapy):

  • Grade 1 to 2 ( to ): After symptoms resolve, resume the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, infusion rate escalation may resume at increments up to the maximum rate of 200 mL/hour.
  • Grade 3 (): After symptoms resolve, restart the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, resume infusion rate escalation as outlined in the “Manufacturer recommended infusion rates and management of IRRs”. Repeat this procedure in the event of of Grade 3 symptoms. Permanently discontinue therapy upon the third occurrence of Grade 3 or greater IRR.
  • Grade 4 (life-threatening): Permanently discontinue therapy.

Administration advice:

  • This drug should be administered by a healthcare professional, with immediate access to equipment and appropriate medical support to manage IRRs.
  • Administer only as an IV infusion after dilution.
  • For dosing instructions of combination agents administered with this drug see the manufacturer product information.
  • If a dose is missed, administer as soon as possible and adjust the dosing schedule accordingly maintaining the treatment interval.

Side Effects

The Most Common

  • tiredness
  • back or joint
  • pain in your arms, legs, or chest
  • decreased appetite
  • of the hands, ankles, or feet
  • pain, burning, or in the hands or feet
  • muscle spasms
  • difficulty falling asleep or staying asleep
  • or bleeding
  • extreme tiredness
  • yellowing of the skin or eyes
  • with yellow or green mucus;
  • stabbing , wheezing, feeling short of breath;
  • numbness, tingling, burning pain; or
  • low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands, and feet, feeling light-headed or short of breath.
  • shortness of breath;
  • nerve problems causing tingling, numbness, or pain;
  • feeling tired or weak;
  • swelling in your hands, ankles, or feet; or
  • cold symptoms such as stuffy nose, sneezing, cough, sore throat.

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chest pain or tightness
  • chills
  • confusion
  • cough
  • difficulty swallowing
  • dizziness
  • ear congestion
  • facial swelling
  • fast heartbeat
  • fever
  • headache
  • hoarseness
  • loss of voice
  • nausea
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, lips, or tongue
  • rapid, shallow breathing
  • skin rash, hives, or itching
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tingling of the hands or feet
  • trouble breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting

Rare

  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • painful blisters on the trunk of body
  • sweating
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • constipation
  • coughing that sometimes produce a pink frothy sputum
  • darkened urine
  • lower back or side pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • swelling in the legs and ankles
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • yellow eyes or skin

Daratumumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Drug Interactions

Pregnancy and Lactation

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Pregnancy

Safety has not been established during pregnancy. IgG1 monoclonal antibodies cross the placenta after the first trimester of pregnancy; therefore, this drug should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus. If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus. Women of reproductive potential should use effective contraception during therapy and for 3 months after cessation of therapy; however, when this drug is used in combination with lenalidomide and dexamethasone, patients should also follow advice about use in pregnancy of those products. Administration of live vaccines to neonates and infants exposed to this drug in utero should be deferred until a hematology evaluation is completed.

Lactation

The effects in the nursing infant are unknown. Human IgG is known to be present in human milk. Data suggest antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

How should this medicine be used?

Daratumumab comes as a liquid (solution) that is given intravenously (into a vein) by a doctor or nurse in a healthcare setting. Your doctor will decide how often you are to receive daratumumab based on other medications that may be given and your body’s response to this medication.

A doctor or nurse will watch you closely while you are receiving the infusion and afterward to be sure you are not having a serious reaction to the medication. You will be given other medications to help prevent and treat reactions to daratumumab prior to your infusion and for the first and second days after you receive your medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: cough, wheezing, throat tightness and irritation, itchy, runny, or stuffy nose, headache, itching, nausea, vomiting, fever, chills, rash, hives, dizziness, lightheadedness, difficulty breathing, chest discomfort, or shortness of breath.

Your doctor may decrease your dose of daratumumab or temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with daratumumab. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

What special precautions should I follow?

Before receiving a daratumumab injection,

  • tell your doctor and pharmacist if you are allergic to daratumumab, any other medications, or any of the ingredients in daratumumab injection. Ask your pharmacist or check the manufacturer’s patient information for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you are receiving blood transfusions or if you have or have ever had shingles (a painful rash that occurs after infection with herpes zoster or chickenpox), breathing problems, hepatitis B (a virus that infects the liver and may cause severe liver damage), or a lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases, which includes chronic bronchitis and emphysema).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should use birth control to prevent pregnancy during your treatment with daratumumab and for at least 3 months after your final dose. Talk to your doctor about the types of birth control that will work for you. If you become pregnant while receiving a daratumumab injection, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving a daratumumab injection.

References

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  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

Internal learning pathway

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