Daratumumab 100 mg/5 mL, 400 mg/20 mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 100 mg/5 mL, 400 mg/20 mL

Reference Brands: Darzalex (USA/EU)

Category: Oncology Cancer Care

Daratumumab is a human monoclonal antibody and a targeted immunotherapy used primarily in the treatment of multiple myeloma and light chain (AL) amyloidosis. It works by binding to CD38, a protein highly expressed on malignant plasma cells, and induces cancer cell death through multiple mechanisms including complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis.

Product Description:

Daratumumab is a human monoclonal antibody against CD38, a glycoprotein expressed at very high density on malignant plasma cells and only sparsely on normal tissue. It kills through several routes at once — complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and phagocytosis, and direct apoptosis — and it also depletes CD38-positive immunosuppressive cells, which restores some anti-tumour immune function.

It is used across multiple myeloma, from newly diagnosed transplant-eligible and ineligible patients to relapsed disease, in combination with immunomodulators, proteasome inhibitors and dexamethasone, and in light chain amyloidosis. Infusion-related reactions are common with the first dose and require premedication and a slow rate. Two laboratory interferences matter clinically: CD38 on red cells causes a false-positive indirect Coombs test, so pre-transfusion phenotyping must be done before treatment starts, and the antibody itself can be mistaken for an M-protein on electrophoresis.

Sourcing notes. Originator biologic under patent. Note that a subcutaneous fixed-dose presentation now dominates use in many markets and is a different product from the intravenous vials listed here — specify which is required. Strict cold chain at 2–8 degrees, no freezing, no shaking.