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What Is Darzalex?

Darzalex is a prescription CD38-directed monoclonal antibody containing daratumumab. It is used in adults with multiple myeloma in several combination regimens and as monotherapy after specified prior treatment. Darzalex is administered by intravenous infusion after dilution and is distinct from the subcutaneous daratumumab product Darzalex Faspro.

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What Is Darzalex?

Darzalex is a prescription CD38-directed monoclonal antibody containing daratumumab. It is used in adults with multiple myeloma in several combination regimens and as monotherapy after specified prior treatment. Darzalex is administered by intravenous infusion after dilution and is distinct from the subcutaneous daratumumab product Darzalex Faspro.

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How Does Darzalex Target Myeloma Cells?

Daratumumab binds to CD38, a protein expressed on myeloma cells and other cells. Binding can directly trigger apoptosis and can recruit immune mechanisms including complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and antibody-dependent cellular phagocytosis. These actions contribute to destruction of CD38-expressing tumor cells.

Who Is Treated With Darzalex?

Darzalex is used for adults with multiple myeloma across newly diagnosed and relapsed or refractory settings. Regimens pair daratumumab with medicines such as lenalidomide, bortezomib, melphalan, thalidomide, carfilzomib, pomalidomide, dexamethasone, or prednisone according to transplant eligibility and prior treatment. Monotherapy is reserved for heavily pretreated disease.

How Are Darzalex Infusions Scheduled?

The recommended intravenous dose is 16 mg per kg of actual body weight for most schedules. In monotherapy and selected combination regimens, treatment is weekly during weeks 1 through 8, every two weeks during weeks 9 through 24, then every four weeks from week 25 onward. Premedication and post-infusion corticosteroids are used.

What Serious Risks Are Linked to Darzalex?

Serious risks include infusion-related reactions, anaphylaxis, infections, neutropenia, thrombocytopenia, and fetal harm. Daratumumab can interfere with blood compatibility testing for up to six months after the final infusion, so blood type and antibody screening are completed before treatment and blood banks are informed about prior therapy.

Frequently Asked Questions About Darzalex

What condition does Darzalex treat?

Darzalex is used in adults with multiple myeloma under treatment-stage and regimen-specific criteria.

How is Darzalex administered?

Darzalex is diluted and given by intravenous infusion by a healthcare professional.

What is the usual Darzalex dose?

The recommended intravenous dose is 16 mg per kg of actual body weight for most regimens.

Can Darzalex affect blood compatibility testing?

Yes. Daratumumab can interfere with antibody screening and cross-matching for up to six months after treatment.

References

DailyMed - DARZALEX (daratumumab) injection, solution, concentrate. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b. Date Accessed September 24, 2026.

Daratumumab. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/drugs/daratumumab. Date Accessed September 24, 2026.

Daratumumab Injection. MedlinePlus. https://medlineplus.gov/druginfo/meds/a616002.html. Date Accessed September 24, 2026.

DARZALEX (daratumumab) Prescribing Information. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf. Date Accessed September 24, 2026.

Definition of Daratumumab. National Cancer Institute Drug Dictionary. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/daratumumab. Date Accessed September 24, 2026.