Indications and Usage

Ibrutinib has been FDA-approved to treat:

• Patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
• Patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
• Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (SLL) with 17p deletion
• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
  • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 
• Patients with Waldenström macroglobulinemia (WM)
• Adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
   

Side effects needing medical attention

Low blood platelet count; diarrhea; low white blood cell count; low red blood cell count; fatigue; muscle and bone pain; swelling of legs and feet; upper respiratory tract infection; nausea; bruising; shortness of breath; constipation; rash; stomach (abdomen) pain; vomiting; decreased appetite; fever; joint pain; mouth sores; sinus infection; and dizziness.

Serious side effects

Bleeding problems; infections; decrease in blood cell counts; kidney problems; second primary cancers. 

For information on how to manage the costs of drug therapy, please see Financial Support, or to speak with an Information Specialist, call (800) 955-4572.