Darzalex: Uses, Dosage & Side Effects - Drugs.com https://www.drugs.com/darzalex.

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Darzalex
Pronunciation: Dar'-zah-lex
Generic name: daratumumab
Dosage form: infusion solution (100 mg/5 mL, 400 mg/20 mL)
Drug class: CD38 monoclonal antibodies

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 11, 2024.

What is Darzalex?
Darzalex (daratumumab) is used to treat multiple myeloma, which is a cancer of white blood cells
called plasma cells. Darzalex can be used alone as a single therapy but is often used together with
other medicines, depending on your clinical situation. Darzalex is given as an infusion.

Darzalex works by blocking a protein called CD38 on myeloma cells, which reduces the growth of
cancer. Darzalex is from a class of medicines called CD38 monoclonal antibodies.

Darzalex (daratumumab) is an infusion that is given into a vein over a period of hours by your
healthcare provider. Darzalex Faspro is a different product. It contains both daratumumab and
hyaluronidase-fihj and is given subcutaneously over 3 to 5 minutes.

How does Darzalex work?

Darzalex mechanism of action:

• Multiple myeloma cells have a large number of proteins called CD38 on their surface. Darzalex
works by binding to the CD38 protein, which kills the myeloma cells, and Darzalex also helps to
increase the ability of the immune system to fight cancer.

What is the difference between Darzalex and Darzalex Faspro?

The difference between Darzalex and Darzalex Faspro is the number of active ingredients, how they
are given, the specific conditions they treat, and the number of systemic administration-related
reactions.

• Darzalex contains the active ingredient daratumumab. It is given intravenously over a period of
hours and is used to treat specific multiple myeloma patients.

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• Darzalex Faspro contains both daratumumab and hyaluronidase-fihj, and is given

subcutaneously over 3 to 5 minutes. Darzalex Faspro is used to treat specific multiple myeloma
patients and is also FDA-approved to treat adults with newly diagnosed light chain (AL)
amyloidosis.

• Darzalex Faspro advantages over Darzalex are that it is faster to administer, it has less systemic
administration-related reactions (ARRs), and is also indicated to treat adults with newly
diagnosed light chain (AL) amyloidosis as well as adults with certain multiple myeloma.

Click this link for more information on Darzalex Faspro.

Related/similar drugs
Darzalex Faspro, Tecvayli, Revlimid, Velcade, Pomalyst, Ninlaro, Kyprolis

Darzalex side effects

Common Darzalex side effects of may include nausea, constipation, diarrhea, fever, shortness
of breath, nerve problems causing tingling, numbness, or pain, feeling tired or weak, swelling
in your hands, ankles, or feet and also cold symptoms such as stuffy nose, sneezing, cough,
sore throat.

Serious Darzalex side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing,
swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, itchy,
or nauseated or if you have a headache, stuffy nose, runny nose, cough, fever, chills, wheezing,
trouble breathing, or a tight feeling in your throat.

Darzalex may cause other serious side effects. Call your doctor at once if you have:

• cough with yellow or green mucus;

• stabbing chest pain, 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.

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Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice
about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Darzalex side effects (more detail)

Who can take Darzalex?

Darzalex is FDA-approved to treat:

• newly diagnosed patients who cannot have autologous stem cell transplant and in patients with
relapsed or refractory multiple myeloma who have received at least one prior therapy (Darzalex to
be used in combination with lenalidomide and dexamethasone)

• newly diagnosed patients who cannot have autologous stem cell transplant combination
(Darzalex to be used in combination with bortezomib, melphalan, and prednisone)

• newly diagnosed patients who can have an autologous stem cell transplant (when used in
combination with bortezomib, thalidomide, and dexamethasone)

• patients who have received at least one prior multiple myeloma medical treatment (Darzalex to be
used in combination with bortezomib and dexamethasone).

• patients with relapsed or refractory multiple myeloma who have received one to three prior
multiple myeloma medical treatments (Darzalex to be used in combination with carfilzomib and
dexamethasone)

• patients who have received at least two prior medical treatments, including lenalidomide and a
proteasome inhibitor (Darzalex to be used in combination with pomalidomide and
dexamethasone)

• patients who have received at least three prior medical treatments, including a proteasome
inhibitor (PI) and an immunomodulatory agent that they have not responded to (Darzalex can be
used alone as a single therapy)

Warnings
If you need to receive a blood transfusion, be sure to tell your caregivers that you are being treated
with Darzalex as it can affect blood tests that are used to match your blood type. Darzalex can affect
blood-typing tests for up to 6 months after you stop using this medicine.

If you've ever had hepatitis B, using daratumumab can cause this virus to become active or get worse.

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Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of
appetite, or yellowing of your skin or eyes. You may need frequent liver function tests while using this
medicine and for several months after you stop.

Men and women should carefully follow all instructions about the use of birth control while you are
using Darzalex in combination with other medicines. See Pregnancy information below.

Before taking this medicine

You should not be treated with Darzalex if you are allergic to daratumumab.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a breathing disorder; or

• herpes zoster (also called shingles) you may be prescribed antiviral medicine to prevent
reactivation of shingles.

• hepatitis B as hepatitis B virus may become active again. Tell your healthcare provider right away
if you get worsening tiredness or yellowing of your skin or the white part of your eyes.

• have hereditary fructose intolerance (HFI). This medicine contains sorbitol which is a source of
fructose. People with HFI cannot break down fructose, which may cause serious side effects.

Pregnancy

Darzalex

• Daratumumab may harm an unborn baby.

• Tell your healthcare provider right away if you become pregnant or think that you may be
pregnant during treatment with this medicine.

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

Darzalex in combination with lenalidomide, pomalidomide, or thalidomide.

• Both men and women using these other drugs must use effective birth control. Even one
dose can cause severe, life-threatening birth defects or death of a baby, if the mother or the
father is taking lenalidomide, pomalidomide, or thalidomide at the time of conception or during

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pregnancy.

• 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 have 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.

◦ Carefully follow all instructions about the use of birth control while you are using Darzalex in
combination with other medicines.

Breastfeeding

If you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast
milk. You should not breastfeed during treatment with this medicine. Talk to your healthcare provider
about the best way to feed your baby during treatment with Darzalex.

Darzalex pregnancy and breastfeeding warnings (more detail)

How is Darzalex given?

• Darzalex is given as an infusion into a vein over a period of hours by your healthcare provider.

• Darzalex is usually given every 1 to 3 weeks during the first several weeks of treatment. Then it is
given once every 4 weeks until your body no longer responds to the medicine. Your doctor will
determine how long to treat you with this medicine.

• You may be given other medications before and after your infusion to help prevent serious side
effects or an allergic reaction (infusion-related reactions.)Keep using these medicines for as long
as your doctor has prescribed.

• You will need frequent medical tests while having treatment with this medicine

Dosage
Usual Adult Dose for Multiple Myeloma

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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); first dose of the every-2-week
dosing schedule is given at Week 9.

• Week 25 and onwards until disease progression: 16 mg/kg IV every 4 weeks; 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); first dose of the every-3-week
dosing schedule is given at Week 7.

• Week 55 onwards until disease progression: 16 mg/kg IV every 4 weeks; 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); first dose of every-2-week dosing
schedule is given at Week 9.

• Stop for high dose chemotherapy and ASCT.

Consolidation

• Weeks 1 to 8: 16 mg/kg IV every 2 weeks; 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).

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

Comments:

• 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.

Detailed Darzalex dosage information

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Darzalex injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely
to occur.

What other drugs will affect Darzalex?

Other drugs may interact with daratumumab, including prescription and over-the-counter medicines,
vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you
start or stop using.

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Darzalex drug interactions (more detail)

Darzalex Package Insert

Review the full Darzalex prescribing information here for more detailed information about this
medicine. Discuss any medical questions you have with your doctor or other health care provider. This
is not all the information you need to know about Darzalex for safe and effective use and does not
take the place of talking to your doctor about your treatment.

Storage
• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).

• Do not freeze or shake.

• Protect from light.

• This product contains no preservatives.

Ingredients
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.

Manufacturer
Janssen Biotech, Inc., Horsham, PA 19044, USA;

Popular FAQ

How long does Darzalex work?

Can Darzalex cure Multiple Myeloma?

Is Darzalex chemotherapy?

How is Darzalex administered?

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References

1. CD38 targeted treatment for multiple myeloma

2. Darzalex (daratumumab) Full Prescribing Information FDA

3. The Good, the Bad and the Unknown of CD38 in the Metabolic Microenvironment and Immune Cell
Functionality of Solid Tumors

Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to
your personal circumstances.

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