Products
Daratumumab was approved as an infusion product in the United States in 2015 and in many countries and the EU in 2016 (Darzalex).
Structure and properties
Daratumumab is a humanized IgG1κ monoclonal antibody with a molecular mass of approximately 148 kDa. It is produced by biotechnological methods.
Effects
Daratumumab (ATC L01XC24) has antitumor and cytotoxic properties. The effects are due to binding to the transmembrane glycoprotein CD38, which is overexpressed on the surface of malignant hematopoietic cells. CD38 plays a role in cell adhesion and signal transduction, among other functions. It also has catalytic (enzymatic) functions. Binding of the antibody leads to cell death via several mechanisms. The half-life of daratumumab is approximately 18 days.
Indications
For the treatment of patients with multiple myeloma who have received prior three drug therapies.
Dosage
According to the SmPC. The drug is administered as an intravenous infusion.
Contraindications
- Hypersensitivity
For complete precautions, see the drug label.
Adverse effects
The most common possible adverse effects include infusion reactions, fatigue, nausea, back pain, fever, cough, upper respiratory tract infection, anemia, neutropenia, and thrombocytopenia.