BRUKINSA® (zanubrutinib) Tablets: NOW AVAILABLE

Stylized blue tablet illustration representing the new BRUKINSA tablet formulation and same flexibility

BRUKINSA® (zanubrutinib)
tablets have replaced capsules

The previously available BRUKINSA capsules, packaged as a 120-count bottle of 80-mg capsules (NDC 72579-0011-02), have been replaced by the new BRUKINSA tablets, packaged as a 60-count bottle of 160-mg tablets (NDC 72579-0122-01).*

This new formulation provides the same flexibility and convenience of taking BRUKINSA. Based on bioequivalence, the same efficacy and safety can be expected.1-3

SEE FAQs ABOUT THE NEW
TABLET FORMULATION

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*NDC has been “zero-filled” to ensure creation of an 11-digit code that meets Health Insurance Portability and Accountability Act (HIPAA) standards.4

The only BTK inhibitor with dosing designed to meet your patients’ needs

DAILY PILL BURDEN HALVED

With BRUKINSA 160-mg tablets, the daily pill burden is reduced by 50%, from four capsules to two tablets¹

REDUCED SIZE FOR EASIER SWALLOWING

The film-coated tablet is almost one-third smaller in length than the capsule, which may make it easier for patients to swallow¹

REDUCE IN SMALL INCREMENTS

BRUKINSA tablets are scored, making them easy for patients to split¹

BRUKINSA tablets offer continued dosing flexibility¹

NEW DOSING RECOMMENDATIONS

Consider for patients with compliance
concerns or for those who prefer taking
their medication once a day

320 mg daily dose

Two tablets taken once daily

Consider for patients who take other
twice-daily medications to maintain a
consistent drug-dosing schedule

320 mg daily dose

One tablet in the morning

One tablet in the evening

STRAIGHTFORWARD DOSAGE MODIFICATIONS

Icon of 1 in a circle highlighting dosage modifications with BRUKINSA tablets continue to be straightforward, with small, incremental dose reductions for adverse reactions

Dosage modifications with BRUKINSA tablets continue to be straightforward, with small, incremental dose reductions for adverse reactions

No dose exchanges are necessary for patients taking BRUKINSA

BRUKINSA tablets are scored, making them easy for patients to split

Reimbursement information and support are just a call away. Call 1-833-234-4363

Oncology Nurse Advocates are available Monday through Friday from 8 AM to 8 PM ET.

To learn more about BRUKINSA and all its indications, visit www.BRUKINSA.com

Images may vary in size based on viewing device and are not exact representations.

Abbreviations: BTK, Bruton tyrosine kinase; FAQs, frequently asked questions; NDC, National Drug Code.

Indications

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

•	Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

•	Waldenström’s macroglobulinemia (WM)

•	Mantle cell lymphoma (MCL) who have received at least one prior therapy.

•	Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

•	Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.

The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

WARNINGS AND PRECAUTIONS

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients.
Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

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 risk 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 before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% 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 patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% of patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

Embryo-Fetal Toxicity

Based 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 BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 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 REACTIONS

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

DRUG INTERACTIONS

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full Prescribing Information.

References: 1. BRUKINSA. Package insert. BeOne Medicines USA, Inc.; 2025. 2. Bioequivalence
of a zanubrutinib tablet compared to capsules in healthy adult participants. NCT05767398.
ClinicalTrials.gov. Updated October 26, 2024. Accessed June 18, 2025. h‌ttp‌s:‌//cli‌nica‌ltrials‌.go‌v/
study/NCT05767398 3. Relative bioavailability of zanubrutinib tablets compared to capsules and
effects of food on the pharmacokinetics of the tablet in healthy adults. NCT05547399.
ClinicalTrials.gov. Updated October 26, 2024. Accessed June 18, 2025. htt‌ps:/‌/‌clini‌caltr‌ial‌s.g‌ov/
study/NCT05547399 4. National Drug Code database background information. US Food and Drug
Administration. Updated March 20, 2017. Accessed June 18, 2025. htt‌ps:/‌/‌w‌ww.fda‌.g‌ov/dr‌ugs/
development-approval-process-drugs/national-drug-code-database-background-information 5.
Calquence. Package insert. AstraZeneca Pharmaceuticals LP; 2025. 6. Imbruvica. Package insert.
Pharmacyclics LLC, Janssen Biotech, Inc; 2024. 7. Jaypirca. Package insert. Lilly USA, LLC; 2024.

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