Brukinsa (zanubrutinib)
An approved treatment for Waldenström Macroglobulinemia and Mantle Cell Lymphoma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Zanubrutinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Zanubrutinib
- Brand name
- Brukinsa
- Development code
- BGB-3111
- Drug class
- BTK inhibitor
- Manufacturer
- BeOne Medicines (formerly BeiGene)
- How it's taken
- Oral capsule or tablet, once or twice a day
A pill taken once or twice a day that blocks BTK, an enzyme cancerous B cells use to grow. The FDA approved it for Waldenström macroglobulinemia on August 31, 2021, after first approving it for mantle cell lymphoma in 2019, and it is also approved for CLL, SLL, and marginal zone and follicular lymphoma.
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Where Zanubrutinib fits
One of several BTK inhibitors used in Waldenström's. ASPEN compared it head to head with ibrutinib: response rates were nearly identical, and the trial did not show the higher rate of deep responses it was designed to test, while some side effects, such as pneumonia and diarrhea, were less common with Brukinsa.
How Zanubrutinib works
BTK is a signaling enzyme in the B-cell receptor pathway. In B cells it switches on the signals that make them multiply, move and stick in place[1]. Zanubrutinib forms a permanent bond with a cysteine in BTK's active site and shuts the enzyme off; in lab studies it stopped cancerous B cells from multiplying and shrank tumors[1].
Side effects and safety
- Bleeding. Grade 3 or worse bleeding, including in the brain and gut, in 3.8% of trial patients and fatal in 0.2%; the risk rises with blood thinners, and the label suggests weighing a 3 to 7 day pause around surgery.
- Infections. Grade 3 or worse infections in 26%, most often pneumonia, and fatal in 3.2%, including hepatitis B reactivation; doctors may add preventive medicines for herpes and pneumocystis.
- Low blood counts. Grade 3 or 4 low neutrophils in 21%, low platelets in 8% and anemia in 8%.
- Second cancers. In 14% of patients, most often skin cancers other than melanoma (8%); sun protection is advised.
- Heart rhythm problems. Atrial fibrillation or flutter in 4.4%, grade 3 or worse in 1.9%, more likely with heart risk factors, high blood pressure or an acute infection.
- Liver injury. Severe and fatal drug-induced liver injury has occurred with BTK inhibitors, including Brukinsa.
- Pregnancy. Can harm an unborn baby; pregnancy should be avoided during treatment and for 1 week after the last dose.
- Complete blood counts regularly
- Bilirubin and liver enzymes before starting and throughout treatment
- Signs of bleeding, infection and irregular heartbeat such as palpitations or dizziness
- Skin checks for new skin cancers
Brukinsa has no boxed warning and no contraindications. Its label warns about bleeding (grade 3 or worse in 3.8% of trial patients and fatal in 0.2%), serious infections (grade 3 or worse in 26%, most often pneumonia, fatal in 3.2%, including hepatitis B reactivation), low blood counts, second cancers in 14% (most often skin cancers other than melanoma, in 8%), atrial fibrillation or flutter in 4.4%, liver injury, and harm to an unborn baby[1].
In the Waldenström's ASPEN trial, the most common side effects with Brukinsa were musculoskeletal pain (45%), upper respiratory infection (44%), bleeding (42%), fatigue (31%), rash (29%), diarrhea (22%) and bruising (20%), and 2% of patients stopped Brukinsa because of a side effect[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Zanubrutinib
The dose is 160mg twice a day or 320mg once a day by mouth, with or without food, until the disease progresses or side effects become unacceptable[1]. It comes as 80mg capsules, swallowed whole and never opened, broken or chewed, and as 160mg scored tablets, swallowed whole and split in half only if the doctor prescribes it. A missed dose is taken as soon as possible the same day, and the usual schedule resumes the next day.
People with severe liver impairment take 80mg twice a day, and the label changes the dose when Brukinsa is combined with moderate or strong CYP3A inhibitors and advises against strong or moderate CYP3A inducers[1].
Availability and cost
Only available as the brand-name product.
Help paying for Brukinsa
The maker of Brukinsa publishes no copay card, but its support program can check your insurance and explain any help that exists. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 7 charity funds for the conditions it treats, 6 were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Insurance and case manager help
Oncology Nurse Advocates help with insurance verification and connect eligible patients with the program's co-pay support, bridge supply and free product assistance. Call 1-833-234-4363, Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The myBeOne Support program participation page names co-pay support, bridge supply and free product assistance but publishes no amounts, caps or eligibility rules, so only the hub is recorded until BeOne publishes terms. Checked on November 2, 2026.
Charity funds
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Clinical Trials Co-Pay Fund (all blood cancers) fundOpen
Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Patient Aid Program fundOpen
Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.
The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.” - From a charity · HealthWell FoundationWaldenstrom Macroglobulinemia fundOpen
Pays for: Copays, premiums or other treatment costs.
- From a charity · NORD RareCareIWMF Waldenstrom Macroglobulinemia Travel and Lodging Assistance fundOpen
Pays for: Travel and lodging for care.
The foundation says: “Accepting Applications” - From a charity · TotalAssist (formerly PAN Foundation)Waldenstrom Macroglobulinemia fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $9,500 per year. Requires health insurance (any kind).
- From a charity · HealthWell FoundationMantle Cell Lymphoma fundOpen
Pays for: Prescription copays; Medicare Part B premiums, up to $8,500 per year. Requires health insurance (any kind).
Every program and charity fund for Waldenström Macroglobulinemia →
Access and eligibility
The Waldenström's approval covers adults, with no limit on earlier treatment or MYD88 status written into the label. The mantle cell lymphoma approval covers adults who have had at least 1 earlier treatment and is an accelerated approval based on response rate.
Source: myBeOne Support
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
ASPEN (NCT03053440) compared Brukinsa 160mg twice a day with ibrutinib in 201 adults with Waldenström's carrying the MYD88 L265P mutation, 82% of whom had relapsed or refractory disease. The response rate (partial response or better) was 77.5% with Brukinsa and 77.8% with ibrutinib, and no patient in either group had a complete response.
Very good partial responses were 15.7% with Brukinsa and 7.1% with ibrutinib, yet the trial did not reach statistical significance on its planned test of more very good partial or complete responses in relapsed or refractory patients[1]. At 12 months, 94.4% of Brukinsa responders were still responding, against 87.9% on ibrutinib. In a second group of 26 evaluable patients without the MYD88 mutation, 50% responded to Brukinsa[1].
Development history
Zanubrutinib (BGB-3111) was developed by BeiGene, which became BeOne Medicines in May 2025[4]. The FDA first approved Brukinsa on November 14, 2019 for mantle cell lymphoma and added Waldenström macroglobulinemia on August 31, 2021[2]. Later approvals added CLL and SLL, marginal zone lymphoma and, with obinutuzumab, follicular lymphoma, and a 160mg tablet joined the 80mg capsule on June 10, 2025[3].
Explore Waldenström Macroglobulinemia and Mantle Cell Lymphoma trials
Other Waldenström Macroglobulinemia & Mantle Cell Lymphoma treatments
Common questions about Zanubrutinib
▸What is Zanubrutinib (Brukinsa)?
A pill taken once or twice a day that blocks BTK, an enzyme cancerous B cells use to grow. The FDA approved it for Waldenström macroglobulinemia on August 31, 2021, after first approving it for mantle cell lymphoma in 2019, and it is also approved for CLL, SLL, and marginal zone and follicular lymphoma.
▸How does Zanubrutinib work?
BTK is a signaling enzyme in the B-cell receptor pathway. In B cells it switches on the signals that make them multiply, move and stick in place[1]. Zanubrutinib forms a permanent bond with a cysteine in BTK's active site and shuts the enzyme off; in lab studies it stopped cancerous B cells from multiplying and shrank tumors[1].
▸What are the side effects of Zanubrutinib?
Brukinsa has no boxed warning and no contraindications. Its label warns about bleeding (grade 3 or worse in 3.8% of trial patients and fatal in 0.2%), serious infections (grade 3 or worse in 26%, most often pneumonia, fatal in 3.2%, including hepatitis B reactivation), low blood counts, second cancers in 14% (most often skin cancers other than melanoma, in 8%), atrial fibrillation or flutter in 4.4%, liver injury, and harm to an unborn baby[1]. In the Waldenström's ASPEN trial, the most common side effects with Brukinsa were musculoskeletal pain (45%), upper respiratory infection (44%), bleeding (42%), fatigue (31%), rash (29%), diarrhea (22%) and bruising (20%), and 2% of patients stopped Brukinsa because of a side effect[1].
▸How is Zanubrutinib taken?
The dose is 160mg twice a day or 320mg once a day by mouth, with or without food, until the disease progresses or side effects become unacceptable[1]. It comes as 80mg capsules, swallowed whole and never opened, broken or chewed, and as 160mg scored tablets, swallowed whole and split in half only if the doctor prescribes it. A missed dose is taken as soon as possible the same day, and the usual schedule resumes the next day. People with severe liver impairment take 80mg twice a day, and the label changes the dose when Brukinsa is combined with moderate or strong CYP3A inhibitors and advises against strong or moderate CYP3A inducers[1].
▸Is Zanubrutinib FDA approved?
Yes, Zanubrutinib (Brukinsa) is FDA approved (2019) for the treatment of Waldenström Macroglobulinemia and Mantle Cell Lymphoma.
▸Is Brukinsa better than ibrutinib for Waldenström's?
Not on how often the disease responded. In ASPEN, the trial that compared them directly, 77.5% responded to Brukinsa and 77.8% to ibrutinib, and the trial did not show the higher rate of very good partial or complete responses it tested for[1].
Less common with Brukinsa: pneumonia (12% vs 26%), diarrhea (22% vs 34%), bruising (20% vs 34%) and muscle spasms (10% vs 28%).
More common with Brukinsa: upper respiratory infections (44% vs 40%), constipation (16% vs 7%) and shortness of breath (14% vs 7%).
Source: Brukinsa prescribing information, Tables 5 and 20.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- BeOne Medicines via DailyMed · 2026-07-21. Brukinsa (zanubrutinib) capsules and tablets prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3e08fe23-d70e-424c-bc51-1222e320f902
- FDA. Brukinsa capsules approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213217
- FDA. Brukinsa tablets approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218785
- BeOne Medicines · 2025-05-26. BeOne Medicines launches following redomiciliation to Switzerland. https://www.businesswire.com/news/home/20250526273239/en/beone-medicines-launches-following-redomiciliation-to-switzerland-marking-a-new-chapter-in-global-oncology
- BeOne Medicines. myBeOne Support for Brukinsa patients. https://www.mybeonesupport.com/brukinsa/patient/