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Darzalex (Daratumumab): Uses, Side Effects and Dosage

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Prescription (Rx)
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100 mg/5 mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Darzalex

What is DARZALEX?

DARZALEX is a prescription medicine used to treat adults with multiple myeloma:

  • in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment who have received at least one prior medicine to treat multiple myeloma.
  • in combination with the medicines bortezomib, melphalan and prednisone, in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
  • in combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
  • in combination with the medicines bortezomib and dexamethasone, in people who have received at least one prior medicine to treat multiple myeloma.
  • in combination with the medicines carfilzomib and dexamethasone, in people whose multiple myeloma has come back or did not respond to treatment who have received one to three prior medicines to treat multiple myeloma.
  • in combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor.
  • alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent.

It is not known if DARZALEX is safe and effective in children.

Do not receive DARZALEX:

  • if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX. See the end of this leaflet for a complete list of ingredients in DARZALEX.

Before you receive DARZALEX, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of breathing problems.
  • have had shingles (herpes zoster).
  • have ever had or might now have a hepatitis B infection as DARZALEX could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during and for some time after treatment with DARZALEX. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes.
  • have hereditary fructose intolerance (HFI). DARZALEX contains sorbitol. Sorbitol is a source of fructose. People with HFI cannot break down fructose, which may cause serious side effects.

  • are pregnant or plan to become pregnant. DARZALEX may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX.

    • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of DARZALEX. Talk to your healthcare provider about birth control methods that you can use during this time.

    • Before starting DARZALEX in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program.

      • The lenalidomide, pomalidomide, and thalidomide REMS has more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
      • For males who have female partners who can become pregnant, there is information in the lenalidomide, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen.
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX passes into your breast milk. You should not breastfeed during treatment with DARZALEX. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive DARZALEX?

  • DARZALEX may be given alone or together with other medicines used to treat multiple myeloma.
  • DARZALEX will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
  • Your healthcare provider will decide the time between doses as well as how many treatments you will receive.

  • Your healthcare provider will give you medicines before each dose of DARZALEX and after each dose of DARZALEX to help reduce the risk of infusion-related reactions.

    If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of DARZALEX?

DARZALEX may cause serious reactions, including:

  • Infusion-related reactions. Infusion-related reactions are common with DARZALEX. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms:
  • shortness of breath or trouble breathing
  • dizziness or lightheadedness (hypotension)
  • cough
  • wheezing
  • heart beating faster than usual
  • low oxygen in the blood (hypoxia)
  • throat tightness or irritation
  • runny or stuffy nose
  • headache
  • itching
  • high blood pressure
  • eye pain
  • nausea
  • vomiting
  • chills
  • fever
  • chest discomfort
  • blurred vision
  • Changes in blood tests. DARZALEX can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX. Tell all of your healthcare providers that you are being treated with DARZALEX before receiving blood transfusions.
  • Infections. DARZALEX can cause serious life-threatening infections that can lead to death. Tell your healthcare provider right away if you develop a fever, trouble breathing, cough, burning or pain when you urinate, or any other signs and symptoms of infection during treatment.
  • Decreases in blood cell counts. DARZALEX can decrease white blood cell counts which help fight infections and blood cells called platelets which help to clot blood. Decreases in blood cell counts are common with DARZALEX, but can be severe. Your healthcare provider will check your blood cell counts during treatment with DARZALEX. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.

The most common side effects of DARZALEX include:

  • cold-like symptoms (upper respiratory infection)
  • diarrhea
  • constipation
  • decreased red blood cells
  • nerve damage causing tingling, numbness or pain
  • tiredness
  • swollen hands, ankles, or feet
  • nausea
  • cough
  • fever
  • shortness of breath
  • feeling weak

These are not all the possible side effects of DARZALEX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DARZALEX that is written for health professionals.

What are the ingredients in DARZALEX?

Active ingredient: daratumumab

Inactive ingredients: may include glacial acetic acid, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, sorbitol, and water for injection.

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA; U.S. License Number 1864

For patent information: www.janssenpatents.com

© 2021 Janssen Pharmaceutical Companies

For more information, call 1-800-526-7736 or go to www.DARZALEX.com.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761036 · View the label on DailyMed

Revision date stated in the text: June 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Darzalex

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class CD38-directed Cytolytic Antibody
Active ingredient Daratumumab 100 mg/5 mL
Dosage form Injection, solution, concentrate
Route Intravenous
Marketing status not in the current FDA NDC Directory
Company (applicant) JANSSEN BIOTECH
FDA approval BLA 761036Biologics License Application (BLA) Approved November 16, 2015
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg/5 mL – 5 ml in 1 vial / 1 in 1 carton NDC 57894-502-05
100 mg/5 mL – 20 ml in 1 vial / 1 in 1 carton NDC 57894-502-20
100 mg/5 mL – 5 ml in 1 vial, single-dose / 1 in 1 box NDC 57894-505-05
100 mg/5 mL – 20 ml in 1 vial, single-dose / 1 in 1 box NDC 57894-505-20

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.