|Brand name(s), other common name(s)||DARZALEX™|
|Drug type||Monoclonal antibody|
|How the drug is given||Injection|
Indications and Usage
Daratumumab is FDA approved 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, or who are double-refractory to a PI and an immunomodulatory agent.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Side effects needing medical attention
Infusion reactions (such as shortness of breath or trouble breathing, headache, dizziness or lightheadedness (hypotension), rash or hives, cough, itching, wheezing, nausea, throat tightness, vomiting, runny or stuffy nose, chills), fatigue, nausea, back pain, fever, cough, cold-like symptoms (upper respiratory infection).