Brief Summary of Prescribing Information for IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib) capsules, for oral use
See package insert for Full Prescribing Information
IMBRUVICA® (ibrutinib) capsules
INDICATIONS AND USAGE
Mantle Cell Lymphoma: IMBRUVICA is indicated for the treatment of 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. Improvements
in survival or disease-related symptoms have not been established. Continued approval for this
indication may be contingent upon verification of clinical benefit in confirmatory trials [see Clinical
Studies (14.1) in full Prescribing Information].
Chronic Lymphocytic Leukemia: IMBRUVICA is indicated for the treatment of patients with chronic
lymphocytic leukemia (CLL) who have received at least one prior therapy [see Clinical Studies (14.2)
in full Prescribing Information].
Chronic Lymphocytic Leukemia with 17p deletion: IMBRUVICA is indicated for the treatment of
patients with chronic lymphocytic leukemia (CLL) with 17p deletion [see Clinical Studies (14.2) in full
Prescribing Information].
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Hemorrhage: Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding,
hematuria and post procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events
of any grade, including bruising and petechiae, occurred in approximately half of patients treated
with IMBRUVICA.
The mechanism for the bleeding events is not well understood.
IMBRUVICA may increase the risk of hemorrhage in patients receiving antipl FV