Darzalex Faspro
Darzalex Faspro ingredients
| Active ingredient | Strength |
|---|---|
| Daratumumab | 1800 mg/15mL |
| Hyaluronidase (Human Recombinant) | 30000 U/15mL |
What Darzalex Faspro is used for
The FDA lists the approved uses on the official label (below). In the EU, daratumumab is approved as Darzalex for:
Multiple Myeloma Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Darzalex Faspro
- Generic name
- Daratumumab and hyaluronidase-fihj (human recombinant)
- Made by
- Janssen Biotech, Inc.
- Forms
- Injection
- Given
- Subcutaneous
- Drug class
- CD38-directed Cytolytic Antibody, Endoglycosidase
- FDA approval
- Biologic licence (BLA) BLA761145
- On the US market since
- 2020
Official information
- MedlinePlus drug information (search for Daratumumab and hyaluronidase-fihj (human recombinant))
In India
- Daratumumab: 2 brands in India
- Hyaluronidase (human recombinant): 7 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Darzalex Faspro?
Darzalex Faspro (Daratumumab and hyaluronidase-fihj (human recombinant)) is a cancer medicine made by Janssen Biotech, Inc., approved by the US FDA.
What are the ingredients of Darzalex Faspro?
Darzalex Faspro contains Daratumumab (1800 mg/15mL); Hyaluronidase (Human Recombinant) (30000 U/15mL).
Is Darzalex Faspro approved in Europe?
The same active substance is approved in the EU as Darzalex.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA