FDA label 6c13a497-8849-4b37-a84d-692910963567

5 WARNINGS AND PRECAUTIONS Tumor Lysis Syndrome (TLS) : Anticipate TLS; assess risk in all patients. Premedicate with anti-hyperuricemics, ensure adequate hydration, and monitor. ( 5.1 ) Serious Infections : Monitor for infection and treat promptly. ( 5.2 ) Neutropenia: Monitor blood counts regularly. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Tumor Lysis Syndrome BEQALZI can cause serious or life-threatening tumor lysis syndrome (TLS). BEQALZI can cause rapid reduction in tumor and changes in blood chemistries consistent with TLS that require prompt management. This can occur as early as 4 hours after the first dose, at any dose increases, and upon restart following dosage interruption. Laboratory or clinical TLS occurred in 7% of the 115 patients with MCL who followed the recommended dose ramp-up. Risk factors for TLS include higher tumor burden such as bulky lymphadenopathy or lymphocytosis and reduced renal function. Assess all patients for TLS risk and provide appropriate prophylaxis, including hydration and anti-hyperuricemics begun prior to the first dose of BEQALZI. Correct relevant chemistry abnormalities prior to starting BEQALZI. Consider hospitalization with intravenous hydration and monitoring and employ more frequent monitoring for patients with high TLS risk. Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed; when restarting BEQALZI, follow the dose modification guidance [see Dosage and Administration (2.3) ] . Concomitant use of sonrotoclax with strong or moderate CYP3A inhibitors increases sonrotoclax exposure, which may increase the risk of TLS at initiation and during the ramp-up phase [see Dosage and Administration (2.4) and Drug Interactions (7.1) ] . 5.2 Serious Infections BEQALZI can cause fatal or serious infections [see Adverse Reactions (6.1) ] . Among patients who received BEQALZI at the recommended dosage in the clinical trial, serious infections occurred in 14% of patients and Grade 3 or higher infections in 17%, with fatal infections in 2.6% of patients. The most common Grade 3 or greater infection was pneumonia (10%). Monitor for signs and symptoms of infection and treat appropriately. Consider prophylactic antimicrobials and immunoglobulins according to guidelines. Withhold or dose reduce BEQALZI based on severity [see Dosage and Administration (2.3) ] . 5.3 Neutropenia BEQALZI can cause serious or severe cytopenias, including neutropenia. Among 115 patients with MCL who received BEQALZI, new or worsening Grade 3 or 4 decrease in neutrophils developed in 18% (Grade 4, 6%). Febrile neutropenia occurred in 1.7% of patients. Monitor complete blood counts throughout treatment. Based on severity, reduce dose, interrupt, or permanently discontinue BEQALZI [see Dosage and Administration (2.3) ] . 5.4 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, BEQALZI can cause fetal harm when administered to a pregnant woman. In embryo-fetal development toxicity studies conducted in pregnant mice and rabbits, oral administration of sonrotoclax during the period of organogenesis caused adverse developmental outcomes, including structural abnormalities and altered fetal growth at approximately ≥2 times the clinical exposure based on the area under the concentration-time curve (AUC) at the recommended dose in humans (320 mg/day). Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BEQALZI and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Lysis Syndrome [see Warnings and Precautions (5.1) ] Serious Infections [see Warnings and Precautions (5.2) ] Neutropenia [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥15%) are pneumonia and fatigue. The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes and neutrophils. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Mantle Cell Lymphoma The safety of BEQALZI was evaluated in 115 adult patients with previously treated MCL in a single-arm, multicenter clinical trial, BGB-11417-201 (NCT05471843) [see Clinical Studies (14.1) ] . The trial required prior receipt of anti-CD20–based therapy and a BTK inhibitor. The trial excluded patients on moderate or strong CYP3A inhibitors or strong CYP3A inducers and required an absolute neutrophil count (ANC) ≥1000/mm 3 ; platelets ≥75,000/mm 3 ; creatinine clearance ≥50 mL/min; AST and ALT ≤3 × upper limit of normal (ULN); and serum total bilirubin ≤2 × ULN. Patients received BEQALZI 320 mg orally once daily following completion of a 4-week ramp-up dosing schedule. Of the 115 patients who received BEQALZI, 52% were exposed for at least 6 months and 34% were exposed for at least 1 year. Serious adverse reactions were reported in 37% of patients who received BEQALZI, most frequently (≥2%) from pneumonia (10%). Fatal adverse reactions occurred in 4.3% of patients, including from pneumonia (2.6%) and sudden death (1.7%). Adverse reactions led to dose interruption of BEQALZI in 27% of patients, dose reduction in 0.9%, and permanent discontinuation in 8%. The most common reasons for dose interruption were infections (10%) and neutropenia (5%). The most common adverse reaction leading to treatment discontinuation was infection (1.7%). Table 7 summarizes select adverse reactions in Study BGB-11417-201, excluding laboratory terms. Table 7: Adverse Reactions (≥10%) in Patients with MCL Who Received BEQALZI in BGB-11417-201 Adverse Reaction BEQALZI (N=115) All Grades (%) Grade 3 or 4 (%) Infections Pneumonia Includes pneumonia, COVID-19 pneumonia, pneumonia bacterial, and other related terms. 16 Additionally includes three fatal cases (2.6%) of pneumonia. 10 Upper respiratory tract infection Includes upper respiratory tract infection, pharyngitis, sinusitis, and other related terms. 12 1.7 General Disorders Fatigue Includes fatigue and asthenia. 16 0.9 Edema Includes edema peripheral, generalized edema, and other related terms. 14 0 Pyrexia 10 0.9 Gastrointestinal Disorders Diarrhea 14 1.7 Constipation 10 0 Skin and Subcutaneous Tissue Disorders Rash Includes rash, dermatitis, drug eruption, and other related terms. 10 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal pain Includes musculoskeletal pain, back pain, bone pain, and other related terms. 10 0 Clinically relevant adverse reactions in <10% of patients who received BEQALZI included: TLS, headache, nausea, vomiting, mucositis, peripheral sensory neuropathy, febrile neutropenia, pneumonitis, herpes zoster infection, and sepsis. Table 8 summarizes new or worsening laboratory abnormalities throughout treatment. Grade 4 laboratory abnormalities in ≥2% of patients included decreases in neutrophils (6%) and platelet count (3.5%). Table 8: Select Laboratory Abnormalities (≥20%) That Worsened from Baseline in Patients with Previously Treated MCL Who Received BEQALZI Laboratory Abnormality The denominator used to calculate the rate varied from 103 to 115 based on the number of patients with a baseline value and at least one post-treatment value. BEQALZI All Grades, % Grade 3 or 4 (%) Hematology Lymphocytes decreased 66 29 Hemoglobin decreased 52 9 Neutrophils decreased 50 18 Platelets decreased 36 9 Chemistry Calcium decreased 42 1.7 Uric acid increased 42 0 Glucose increased 35 0 Creatinine increased 32 1.7 Potassium decreased 30 4.3 Sodium decreased 29 9 Aspartate aminotransferase increased 27 2.8 Alkaline phosphatase increased 25 0 Alanine aminotransferase increased 22 0.9 Calcium increased 21 0

<table width="85%"><caption>Table 7: Adverse Reactions (&#x2265;10%) in Patients with MCL Who Received BEQALZI in BGB-11417-201</caption><col width="56%" align="left" valign="middle"/><col width="22%" align="center" valign="middle"/><col width="22%" align="center" valign="middle"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2">Adverse Reaction</th><th styleCode="Rrule" colspan="2">BEQALZI (N=115)</th></tr><tr><th styleCode="Rrule" align="center">All Grades (%)</th><th styleCode="Rrule">Grade 3 or 4 (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Infections</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pneumonia<footnote>Includes pneumonia, COVID-19 pneumonia, pneumonia bacterial, and other related terms.</footnote></td><td styleCode="Rrule">16<footnote>Additionally includes three fatal cases (2.6%) of pneumonia.</footnote></td><td styleCode="Rrule">10</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Upper respiratory tract infection<footnote>Includes upper respiratory tract infection, pharyngitis, sinusitis, and other related terms.</footnote></td><td styleCode="Rrule">12</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">General Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Fatigue<footnote>Includes fatigue and asthenia.</footnote></td><td styleCode="Rrule">16</td><td styleCode="Rrule">0.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Edema<footnote>Includes edema peripheral, generalized edema, and other related terms.</footnote></td><td styleCode="Rrule">14</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pyrexia</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0.9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Gastrointestinal Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Diarrhea</td><td styleCode="Rrule">14</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Constipation</td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Rash<footnote>Includes rash, dermatitis, drug eruption, and other related terms.</footnote></td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Musculoskeletal and Connective Tissue Disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr><td styleCode="Lrule Rrule">Musculoskeletal pain<footnote>Includes musculoskeletal pain, back pain, bone pain, and other related terms.</footnote></td><td styleCode="Rrule">10</td><td styleCode="Rrule">0</td></tr></tbody></table>

<table width="85%"><caption>Table 8: Select Laboratory Abnormalities (&#x2265;20%) That Worsened from Baseline in Patients with Previously Treated MCL Who Received BEQALZI</caption><col width="36%" align="left" valign="middle"/><col width="30%" align="center" valign="middle"/><col width="34%" align="center" valign="middle"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2">Laboratory Abnormality<footnote>The denominator used to calculate the rate varied from 103 to 115 based on the number of patients with a baseline value and at least one post-treatment value.</footnote></th><th styleCode="Rrule" colspan="2">BEQALZI</th></tr><tr><th styleCode="Rrule" align="center">All Grades, %</th><th styleCode="Rrule">Grade 3 or 4 (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Hematology</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Lymphocytes decreased</td><td styleCode="Rrule">66</td><td styleCode="Rrule">29</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hemoglobin decreased</td><td styleCode="Rrule">52</td><td styleCode="Rrule">9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Neutrophils decreased</td><td styleCode="Rrule">50</td><td styleCode="Rrule">18</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Platelets decreased</td><td styleCode="Rrule">36</td><td styleCode="Rrule">9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Chemistry</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Calcium decreased</td><td styleCode="Rrule">42</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Uric acid increased</td><td styleCode="Rrule">42</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Glucose increased</td><td styleCode="Rrule">35</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Creatinine increased</td><td styleCode="Rrule">32</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Potassium decreased</td><td styleCode="Rrule">30</td><td styleCode="Rrule">4.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Sodium decreased</td><td styleCode="Rrule">29</td><td styleCode="Rrule">9</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Aspartate aminotransferase increased</td><td styleCode="Rrule">27</td><td styleCode="Rrule">2.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Alkaline phosphatase increased</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Alanine aminotransferase increased</td><td styleCode="Rrule">22</td><td styleCode="Rrule">0.9</td></tr><tr><td styleCode="Lrule Rrule">Calcium increased</td><td styleCode="Rrule">21</td><td styleCode="Rrule">0</td></tr></tbody></table>