b'84 Available on theIMPORTANT SAFETY INFORMATION(CONT)VA National andWARNINGS AND PRECAUTIONS(CONT)TRICARE Formularies InfectionsFatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate NOW APPROVED IN CLL/SLL patients for fever or other signs and symptoms of infection and treat appropriately.CytopeniasGrade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%) and anemia (7%) based on DEMONSTRATED SUPERIORITYlaboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients. WITH BRUKINSA IN CHRONICMonitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or LYMPHOCYTIC LEUKEMIAdiscontinue treatment as warranted. Treat using growth factor or transfusions, as needed.Second Primary Malignancies(CLL)/SMALL LYMPHOCYTICSecond primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer LYMPHOMA (SLL) reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor BRUKINSA is the onlyBRUKINSA achievedpatients for the development of second primary malignancies.kinase inhibitor to achievesuperiority in first-lineCardiac Arrhythmiassuperiority in second-linetherapy vs bendamustineSerious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or therapy vs ibrutinib + rituximab higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be ALPINE (Study 305) SEQUOIA (Study 304)at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients. Phase 3; primary endpoint: Phase 3; primary endpoint:Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest overall response rate progression-free survival discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.Embryo-Fetal ToxicityBased on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking To learn more about the Bruton tyrosine kinase (BTK) inhibitorBRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for BRUKINSA and all its indications, visit BRUKINSA.com 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.ADVERSE REACTIONSIn this pooled safety population, the most common adverse reactions, including laboratory abnormalities, INDICATION in 30% of patients who received BRUKINSA (N=1550) included decreased neutrophil count (42%), upper BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocyticrespiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletalleukemia (CLL) or small lymphocytic lymphoma (SLL). pain (30%).DRUG INTERACTIONSIMPORTANT SAFETY INFORMATION CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA WARNINGS AND PRECAUTIONS dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to Hemorrhage 80 mg twice daily.Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated withCYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinalbe recommended with moderate CYP3A inducers.hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSASPECIFIC POPULATIONSmonotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excludingHepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is purpura and petechiae, occurred in 30% of patients.80 mg orally twice daily.Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the riskPlease see Brief Summary of Prescribing Information on the following pages.of hemorrhage.Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. BRUKINSA and BeiGene are registered trademarks owned by BeiGene, Ltd or its affiliates.BeiGene, Ltd. 2023 Please see Brief Summary of Prescribing Information on the following pages. All Rights Reserved. 0123-BRU-PRC-051 02/23BeiGene Market AccessBrukinsa Trim: 7.875 x 10.75CLL Now Approved Federal Bleed: 0.125 all around 0123-BRU-PRC-051 02/23 Safety:0.375 all aroundSix page (3 spreads) journal ad'