Established safety and tolerability profile over 5 years2

*Of the 106 patients included in the safety population, 75 received IMBRUVICA® + rituximab and 31 received IMBRUVICA® monotherapy2

All-grade TEAEs occurring in ≥20% of patients with WM (N=106)*

Data suggest all-grade AE rates generally decreased or remained stable over time except hypertension and muscle spasms.

  • Infusion-related reactions occurred in 30% patients from 0-1 year and did not occur from 1-5 years.2

Grade ≥3 treatment-emergent AEs occurring in ≥4% of patients with WM (N=106)*

Data suggest Grade ≥3 AE rates generally decrease or remained stable over time.

The median treatment duration was 47.7 months (range, 1.0 to 58.9) with IMBRUVICA® + rituximab and 40.7 months (range, 0.3 to 61.1) with IMBRUVICA® monotherapy.2

Includes multiple preferred terms.

Major hemorrhage was a subset of hemorrhagic events, including the following: Grade ≥3 nonserious treatment-emergent adverse events, serious adverse events, and treatment-emergent adverse events (regardless of grade or seriousness) representing CNS hemorrhage.2

These long term safety data have not been reviewed by the FDA and are not included in the Prescribing Information for IMBRUVICA®.

In a long-term safety analysis over 5 years of 1,284 patients with B-cell malignancies treated for a median of 36 months (range, 0 to 98 months):1

  • The cumulative rate of hypertension increased over time
  • The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 7% (year 1-2), 9% (year 2-3), 9% (year 3-4), and 9% (year 4-5)
  • The overall incidence for the 5-year period was 11%
  • Warnings and precautions include: hemorrhage; infections; cardiac arrhythmias, cardiac failure, and sudden death; hypertension; cytopenias; second primary malignancies; tumor lysis syndrome; and embryo-fetal toxicity.1


AE=adverse event, CNS=central nervous system, FDA=Food and Drug Administration, TEAE=treatment-emergent adverse event, WM=Waldenström’s Macroglobulinemia.

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2Data on file.