BRUKINSA patients can call the myBeOne Support^™ program to talk to a dedicated nurse: 1-833-234-4363

DOSING SCHEDULE FOR BRUKINSA + OBINUTUZUMAB^1,2

BRUKINSA® (zanubrutinib) + obinutuzumab dosing schedule

Maximum total duration of obinutuzumab: ~30 months (maximum 20 doses)²

Flexibility to tailor the schedule to your patients

ONCE DAILY

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

320 mg daily dose

(four 80-mg capsules once daily)

TWICE DAILY

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

320 mg daily dose

(two 80-mg capsules AM
and two 80-mg capsules PM)

In Cycle 1, 100 mg obinutuzumab could be administered on Day 1 and 900 mg on Day 2 at investigator discretion in ROSEWOOD (Study 212).¹

Refer to obinutuzumab Prescribing Information for additional dosing and administration information.

The only BTKi with
recommended dosage for
severe hepatic impairment^1,3,4

Adjust dose to 80 mg twice daily
No dose adjustment needed for mild to moderate hepatic impairment

Although the safety of BRUKINSA has not been evaluated in patients with severe hepatic impairment, there is no caution to avoid use in these patients.

ADDITIONAL FLEXIBILITY: STRAIGHTFORWARD DOSE MODIFICATIONS WITHOUT EXCHANGES¹

Straightforward dose modification

Simply reduce the number of BRUKINSA capsules

Ability to reduce the dose in small increments

Rates of dose reductions (0.8%-11%) were low across BRUKINSA studies

No dose exchanges needed

BRUKINSA does not require a new prescription or dose exchange for dose reductions

Can be taken with or without food. Can be taken with a high-fat meal—BRUKINSA drug concentration (AUC) is not affected
Advise patients to swallow capsules whole with water—do not open, break, or chew capsules

If a dose of BRUKINSA is missed, it should be taken as soon as possible with a return to the normal schedule the following day

BRUKINSA should be taken until disease progression or unacceptable toxicity.

AUC=area under the concentration-time curve; BTKi=Bruton’s tyrosine kinase inhibitor; FL=follicular lymphoma; R/R=relapsed/refractory.

DOWNLOAD GUIDE TO DOSING AND ADMINISTRATION OF BRUKINSA

NO DOSE ADJUSTMENTS REQUIRED WITH THESE COMMON MEDICATIONS

Gastric Acid Reducing Agents¹

Proton pump inhibitors

Including, but not limited to:

Omeprazole
Esomeprazole

Lansoprazole

H2-receptor antagonists

Including, but not limited to:

Famotidine
Ranitidine
Nizatidine

Anticlotting Medication^1,5

Anticoagulants

Heparins
Direct thrombin inhibitors
Factor Xa inhibitors

Vitamin K antagonists

Antiplatelets

Aspirin
P2Y12 inhibitors
Phosphodiesterase inhibitors
PAR-1 antagonists

BRUKINSA was allowed to be coadministered in clinical trials with antiplatelets and anticoagulants (as long as INR was ≤1.5 and aPTT ≤1.5 x ULN).^5-7

Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding.¹

WITH BRUKINSA, DOSE MODIFICATIONS ARE AS STRAIGHTFORWARD AS REDUCING THE NUMBER OF PILLS, WITH THE ABILITY TO DOSE REDUCE IN SMALL INCREMENTS¹

≥Grade 3 events requiring dose modifications

Grade 3 or Grade 4 febrile neutropenia
Platelet count decreased to 25,000-50,000/mm³ with significant bleeding

Neutrophil count decreased to <500/mm³*
Platelet count decreased to <25,000/mm³*
Severe or life-threatening non-hematological toxicities^†

*Lasting more than 10 consecutive days.

^†Evaluate the benefit-risk before resuming treatment at the same dosage for Grade 4 non-hematological toxicity.

aPTT=activated partial thromboplastin time; INR=International Normalized Ratio; PAR-1=protease-activated receptor 1; ULN=upper limit of normal.

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IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking BRUKINSA?

Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:

have bleeding problems.
have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.
have an infection.
have or had heart rhythm problems.
have high blood pressure.
have liver problems, including a history of hepatitis B virus (HBV) infection.
are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.

Females should avoid getting pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
Males should avoid getting female partners pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.

are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for 2 weeks after the last dose of BRUKINSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:

Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:

blood in your stools or black stools (looks like tar)
pink or brown urine
unexpected bleeding, or bleeding that is severe or you cannot control
vomit blood or vomit that looks like coffee grounds
cough up blood or blood clots
increased bruising
dizziness
weakness
confusion
change in speech
headache that lasts a long time

Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.
Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:

your heartbeat is fast or irregular
feel lightheaded or dizzy
pass out (faint)
shortness of breath
chest discomfort

Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

The most common side effects of BRUKINSA include:

decreased white blood cell count
decreased platelet count
upper respiratory tract infection
bleeding
muscle, bone, or joint pain

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is BRUKINSA?

BRUKINSA is a prescription medicine used to treat adults 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 treatment for their cancer.
Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of treatment.
Follicular lymphoma (FL), in combination with the medicine obinutuzumab, when the disease has come back or did not respond to treatment and who have received at least two prior treatments.

It is not known if BRUKINSA is safe and effective in children.

Please see full Prescribing Information including Patient Information.

References: 1. BRUKINSA. Package insert. BeiGene USA, Inc.; 2025. 2. Zinzani PL, Mayer J, Flowers CR, et al. ROSEWOOD: a phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. J Clin Oncol. 2023;41(33):5107-5117. 3. CALQUENCE. Package insert. AstraZeneca Pharmaceuticals LP; 2025. 4. IMBRUVICA. Package insert. Pharmacyclics LLC, Janssen Biotech, Inc; 2024. 5. Tam CS, Opat S, Zhu J, et al. Pooled analysis of safety data from monotherapy studies of the Bruton tyrosine kinase (BTK) inhibitor, zanubrutinib (BGB-3111) in B-cell malignancies. Poster presented at: European Hematology Association (EHA) 2019 Annual Meeting; June 13-16, 2019. Abstract PS1159. 6. BeiGene. Study of the safety and pharmacokinetics of BGB-3111 in subjects with B-cell lymphoid malignancies. ClinicalTrials.gov website. NCT02343120. Last updated April 28, 2022. Accessed December 6, 2023. https://clinicaltrials.gov/ct2/show/NCT02343120 7. Data on file. BeiGene USA, Inc.

Want to learn about a different indication?

CLL/SLL WM MCL MZL

BRUKINSA for FL The BRUKINSA Difference

Study Design Efficacy Safety

DOSING SCHEDULE FOR BRUKINSA + OBINUTUZUMAB1,2