Prescription medicine

Daratumumab and hyaluronidase Brand names: Darzalex

Daratumumab and hyaluronidase (Darzalex) is a prescription medicine. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the daratumumab and hyaluronidase FDA label on DailyMed (effective September 3, 2026); every daratumumab and hyaluronidase label on DailyMed.

Highlights of the record

FDA label of September 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, l

Forms and strengths

1800 mg/15ml / 15ml

Injection.

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 2,880 through July 30, 2026

What is daratumumab and hyaluronidase used for?

From the label: indications and usage
DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple […]

Conditions named in the indications of daratumumab and hyaluronidase's FDA labels, with every medicine labeled for each:

Leukemia, lymphoma and myeloma

From other daratumumab and hyaluronidase labels
Leukemia, lymphoma and myeloma: High-Risk Smoldering Multiple Myeloma DARZALEX FASPRO as monotherapy is indicated for the treatment of adult patients with high-risk smoldering multiple myeloma.

FDA pharmacologic class: CD38-directed Cytolytic Antibody and Endoglycosidase.

Source: FDA drug label (Darzalex Faspro), Janssen Biotech, Inc., effective September 3, 2026 (SPL set 4bb241af-4299-4373-8762-2d6709515db0), via openFDA; the full label on DailyMed

Is there a generic for daratumumab and hyaluronidase (Darzalex)?

No generic daratumumab and hyaluronidase is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the daratumumab and hyaluronidase label say about other medicines?

The daratumumab and hyaluronidase label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Acetaminophen	warnings and precautions	Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen and corticosteroids [see Dosage and Administration (2.6) ].
Bortezomib	warnings and precautions	Toxicity in Patients with Light Chain (AL) Amyloidosis Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone [see Adverse Reactions (6.1) ].
Cyclophosphamide	warnings and precautions	Toxicity in Patients with Light Chain (AL) Amyloidosis Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone [see Adverse Reactions (6.1) ].
Dexamethasone	warnings and precautions	Toxicity in Patients with Light Chain (AL) Amyloidosis Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone [see Adverse Reactions (6.1) ].
Lenalidomide	warnings and precautions	The combination of DARZALEX FASPRO with lenalidomide, thalidomide or pomalidomide is contraindicated in pregnant women, because lenalidomide, thalidomide or pomalidomide may cause birth defects and death of the unborn child.
Pomalidomide	warnings and precautions	The combination of DARZALEX FASPRO with lenalidomide, thalidomide or pomalidomide is contraindicated in pregnant women, because lenalidomide, thalidomide or pomalidomide may cause birth defects and death of the unborn child.
Thalidomide	warnings and precautions	The combination of DARZALEX FASPRO with lenalidomide, thalidomide or pomalidomide is contraindicated in pregnant women, because lenalidomide, thalidomide or pomalidomide may cause birth defects and death of the unborn child.

Check daratumumab and hyaluronidase against other medicines

Source: FDA drug label (Darzalex Faspro), Janssen Biotech, Inc., effective September 3, 2026 (SPL set 4bb241af-4299-4373-8762-2d6709515db0), via openFDA; the full label on DailyMed

What do FAERS reports show for daratumumab and hyaluronidase?

The FDA Adverse Event Reporting System holds 2,880 reports that list daratumumab and hyaluronidase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 111 are coded as a death and 423 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Fatigue (named in the label)218
Product Dose Omission Issue (a use or a product term, not a reaction)215
Off Label Use (a use or a product term, not a reaction)203
Rash (named in the label)151
Diarrhoea (named in the label)136
Nausea (named in the label)113
Dyspnoea (named in the label)100
Neuropathy Peripheral (named in the label)99

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as daratumumab and hyaluronidase?

6 other medicines are given the same way (subcutaneous) and in the same FDA class as daratumumab and hyaluronidase or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (subcutaneous)	Pharmacy cost	Shortage
Isatuximab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Elranatamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Epcoritamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Mosunetuzumab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Talquetamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Teclistamab	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry

Every medicine labeled for the same conditions as daratumumab and hyaluronidase

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to daratumumab and hyaluronidase: 6 medicines for the same use
Other cd38-directed cytolytic antibodys: the pharmacologic class, with prices and generics
Daratumumab and hyaluronidase side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other