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IMBRUVICA (ibrutinib) Approved by U.S. FDA for the First-line Treatment of Chronic Lymphocytic Leukemia
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The safety of IMBRUVICA in this patient population was consistent with previously reported studies. The adverse reactions (AR) reported in the U.S. Prescribing Information reflect exposure to IMBRUVICA with a median duration of 17.4 months versus a median exposure to chlorambucil of 7.1 months: nearly 2.5 times longer exposure for IMBRUVICA. Warnings and Precautions include hemorrhage, infections, cytopenias, atrial fibrillation, hypertension, second primary malignancies, embryo-fetal toxicity and tumor lysis syndrome. The most commonly occurring adverse reactions of all Grades in CLL patients treated with IMBRUVICA in the RESONATE-2 trial (>20%) were diarrhea, musculoskeletal pain, cough and rash.
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Related Keywords Imbruvica, Ibrutinib, Fda, Chronic Lymphocytic Leukemia, Resonate-2, Chlorambucil, Chemotherapy, Hematologic Malignancies, Tumor Suppressor Gene P53, Chromosome 17