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. 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].
Waldenström’s Macroglobulinemia: IMBRUVICA is indicated for the treatment of patients with
Waldenström’s macroglobulinemia (WM) [see Clinical Studies (14.3) in Full Prescribing Information].
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA. 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 antiplatelet or anticoagulant
therapies.
Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery
depending upon the type of surgery and the risk of bleeding [see Clinical Studies (14) in Full
Prescribing Information].
Infections: Fatal and non-fatal infections have occurred with IMBRUVICA therapy. Grade 3 or
greater infections occurred in 14% to 26% of patients. [See Adverse Reactions]. Cases of progressive
multifocal leukoencephalopat