|Brand name(s), other common name(s)||CopiktraTM|
|Drug type||Inhibitor of phosphoinositide 3-kinase (PI3K)|
|How the drug is given||Oral/by mouth|
Indications and Usage
Duvelisib is approved for the treatment of adult patients with
- Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
- Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. This indication is approved under accelerated approval based on overall 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
Diarrhea or colitis, neutropenia, rash, fatigue, fever, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
Use of Copiktra is associated with a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.
Additionally, use of Copiktra is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of Copiktra. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity.