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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:

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.

Click this link for more information on Darzalex Faspro.

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:

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.

Who can take Darzalex? 

Darzalex is FDA-approved to treat:

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. 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:

Pregnancy

Darzalex

Darzalex in combination with lenalidomide, pomalidomide, or thalidomide. 

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.

How is Darzalex given?

Dosage

Usual Adult Dose for Multiple Myeloma

Dosing schedule in combination with lenalidomide or pomalidomide (4-week cycle) and low-dose dexamethasone and for monotherapy: 

Dosing schedule in combination with bortezomib, melphalan, and prednisone 6-week cycle:

Dosing schedule in combination with bortezomib, thalidomide, and dexamethasone 4-week cycle:

Induction

Consolidation

Dosing schedule in combination with bortezomib and dexamethasone 3-week cycle: 

Dosing schedule with carfilzomib and dexamethasone 4-week cycle:

Comments:

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.

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

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

Darzalex is administered until signs of progression of multiple myeloma (MM) occur, or side effects become intolerable. Continue reading

Although Darzalex cannot cure multiple myeloma it can improve the quality and length of life in most people. There are two types of Darzalex: Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase). Continue reading

Darzalex is NOT chemotherapy it is a monoclonal antibody that may also be called a targeted treatment. Darzalex works by binding to a specific protein called CD38 on the surface of multiple myeloma cells, causing cell death. Continue reading

Darzalex IV is administered by an intravenous infusion (a bag of the solution is transfused directly into a vein) and Darzalex Faspro is given as a subcutaneous (SC) injection under the skin. Continue reading

Further information

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