Daratumumab
Cd38 (Clusters Of Differentiation 38) Inhibitors
Sold as DARZALEX · DARZALEX SC
- Drug class
- Cd38 (Clusters Of Differentiation 38) Inhibitors
- Availability
- See label
- Routes
- Subcutaneous, Intravenous
- Markets covered
- 3
- Products on record
- 13
Overview
Daratumumab is an active pharmaceutical ingredient in the Cd38 (Clusters Of Differentiation 38) Inhibitors group (L01FC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 9 | May 15, 2026 |
| CA Canada | Health Canada | 3 | December 31, 2025 |
| EU European Union | EMA | 1 | April 28, 2026 |
GBUnited Kingdom· MHRA
9 products
Uses
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. 1). • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
CACanada· Health Canada
3 products
Uses
DARZALEX® (daratumumab for injection) is indicated: • in combination with bortezomib, thalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
• in combination with lenalidomide and dexamethasone, or with bortezomib, melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
• in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy. • for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD.
EUEuropean Union· EMA
1 product
Uses
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, 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.
as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Drug interactions
Known interactions involving Daratumumab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB002420677 · revised May 15, 2026
- [2]Health Canada (DPD) · 02455951 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/004077 · revised April 28, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.