- Active ingredient
- daratumumab
- Strength
- 400mg/20ml
- Form
- vial
- Manufacturer
- janssen cilag > soficopharm
- Route
- injection
Uses
Daratumumab is an anti-CD38 monoclonal antibody indicated for treatment of multiple myeloma in adults, including newly diagnosed patients ineligible for autologous stem cell transplant (in combination with lenalidomide/dexamethasone, bortezomib/melphalan/prednisone, or bortezomib/thalidomide/dexamethasone) and patients with relapsed or refractory multiple myeloma after at least one prior therapy.
Do not use if
Contraindicated in patients with a history of severe hypersensitivity reactions (such as anaphylaxis) to daratumumab or any component of the formulation.
Side effects
The most common adverse reactions include infusion-related reactions (fever, chills, nausea, cough), fatigue, neutropenia, thrombocytopenia, anemia, and infections. Infusion-related reactions are most common with the first infusion.
Warnings
Infusion-related reactions may be severe; premedicate and monitor patients during and after infusion. Increased risk of serious infections; monitor for signs of infection. Daratumumab interferes with blood bank compatibility testing (anti-CD38 reactivity); inform blood bank of treatment. Embryo-fetal toxicity: avoid during pregnancy.
How it works
Daratumumab is an IgG1-kappa human monoclonal antibody that binds to CD38, a transmembrane glycoprotein highly expressed on multiple myeloma cells. It induces tumor cell death through multiple mechanisms including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and apoptosis.
Storage
Store refrigerated at 2°C–8°C (36°F–46°F). Do not freeze or shake. Protect from light.
