b'B:8.125"T:7.875"S:6.875"Start with IMBRUVICA in 1L CLL 1L I V I N GL O N G E RW I T H O U TP R O G R E S S I O NSuperior PFS: IMBRUVICA + rituximab vs FCR in E1912 189% (95% CI: 85, 92) estimated PFS rate with IMBRUVICA + rituximabat 3 years vs 70% (95% CI: 61, 78) with FCR in patients 70 years old 1,2HR=0.34 (95% CI: 0.22, 0.52; P 1,30.0001) (primary endpoint)CLL/ IMBRUVICA (ibrutinib) is a kinase inhibitor indicated for the treatment of adult patients with:SLLChronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). 1L=frontline, CI=con\x1f dence interval, FCR=\x1e udarabine, cyclophosphamide, and rituximab, HR=hazard ratio, PFS=progression-free survival.Visit IMBRUVICAHCP.com to learn moreSecond Primary Malignancies: Other malignancies (10%), includingApproximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and non-skin carcinomas (4%), occurred among the 1,476 patients whoMZL [13%]) of patients discontinued due to adverse reactions. received IMBRUVICA in clinical trials. The most frequent second* Treatment-emergent decreases (all grades) were based on laboratory measurements. S:9.75" T:10.75" B:11"primary malignancy was non-melanoma skin cancer (6%).Tumor Lysis Syndrome: Tumor lysis syndrome has beenDRUG INTERACTIONSinfrequently reported with IMBRUVICA. Assess the baseline riskCYP3A Inhibitors: Co-administration of IMBRUVICA with strong (e.g., high tumor burden) and take appropriate precautions. or moderate CYP3A inhibitors may increase ibrutinib plasma Monitor patients closely and treat as appropriate. concentrations. Dose modifi cations of IMBRUVICA may be recommended when used concomitantly with posaconazole, Embryo-Fetal Toxicity: Based on fi ndings in animals, IMBRUVICAvoriconazole, and moderate CYP3A inhibitors. Avoid concomitant can cause fetal harm when administered to a pregnant woman.use of other strong CYP3A inhibitors. Interrupt IMBRUVICA if Advise pregnant women of the potential risk to a fetus. Advisestrong inhibitors are used short-term (e.g., for7 days). See dose females of reproductive potential to use effective contraceptionmodifi cation guidelines in USPI sections 2.3 and 7.1.during treatment with IMBRUVICA and for 1 month after the lastCYP3A Inducers: Avoid coadministration with strong CYP3A inducers.dose. Advise males with female partners of reproductive potential to use effective contraception during the same time period. SPECIFIC POPULATIONSHepatic Impairment (based on Child-Pugh criteria): Avoid use ADVERSE REACTIONS of IMBRUVICA in patients with severe hepatic impairment. In The most common adverse reactions (30%) in patients with B-cellpatients with mild or moderate impairment, reduce recommended malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopeniaIMBRUVICA dose and monitor more frequently for adverse (54.5%)*, diarrhea (43.8%), fatigue (39.1%), musculoskeletal painreactions of IMBRUVICA.(38.8%), neutropenia (38.6%)*, rash (35.8%), anemia (35.0%)*, and bruising (32.0%). Please see Brief Summary on the following pages.The most common Grade3 adverse reactions (5%) in patientsReferences: 1. IMBRUVICA (ibrutinib) Prescribing Information. with B-cell malignancies (MCL, CLL/SLL, WM and MZL) werePharmacyclics LLC. 2. Data on fi le. Pharmacyclics LLC. neutropenia (20.7%)*, thrombocytopenia (13.6%)*, pneumonia3. Shanafelt TD, Wang XV, Kay NE, et al. Ibrutinib-rituximab (8.2%), and hypertension (8.0%). or chemoimmunotherapy for chronic lymphocytic leukemia. Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10%N Engl J Med. 2019;381(5):432-443.(MZL) of patients had a dose reduction due to adverse reactions.Pharmacyclics LLC 2021 Janssen Biotech, Inc. 202102/21 PRC-07705aDate: November 17, 2021 1:03 PM Brand: IMBRUVICAColors: CMYKFile Name: PRC-07705a_868128_v1 Size: 7.875" x 10.75"page 2 (Right Hand Page) 100, 0, 0, 35 =Customer Code: PRC-07705a Description: Living Longer Without Progression 54, 0, 100, 0 =We Are Alexander #: 868128 Pub: U.S. Medicine Directory'