Zanubrutinib
Zanubrutinib is a targeted cancer medicine (a BTK inhibitor) used in adults for several B-cell blood cancers, including mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Zanubrutinib (Brukinsa) is a targeted cancer medicine taken by mouth, on the U.S. market since about 2019, that blocks BTK, a protein cancerous B-cells need to grow. It treats mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma. Most people tolerate it fairly well, mainly noticing easy bruising, cold-like infections and diarrhea. The thing to watch for is serious bleeding or infection, so report black or bloody stools, a severe headache or a fever right away. Expect regular blood counts and liver tests, plus attention to heart rhythm, though rhythm problems tend to be less frequent than with the older ibrutinib.
Clinical pearls
- Tell any surgeon or dentist you take it, since it is often paused for a few days before and after surgery.
- Antifungals like fluconazole or voriconazole, and the antibiotic clarithromycin, raise zanubrutinib levels, so your dose may need lowering.
- Rifampin sharply lowers its levels and should be avoided, as should rifabutin and efavirenz, so flag any new tuberculosis or HIV medicine.
- Use sun protection and report new or changing skin spots, because skin cancers have developed in people taking it.
Patient information guide A plain-language walkthrough of Zanubrutinib, written from its FDA label.
What Zanubrutinib is used for
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Zanubrutinib is used in adults for these B-cell cancers:
- Mantle cell lymphoma (MCL) in people who have had at least one prior therapy (accelerated approval).
- Waldenström's macroglobulinemia (WM).
- Relapsed or refractory marginal zone lymphoma (MZL) after at least one anti–CD20-based regimen (accelerated approval).
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Relapsed or refractory follicular lymphoma (FL), with obinutuzumab, after two or more lines of systemic therapy (accelerated approval).
How Zanubrutinib works
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Zanubrutinib blocks BTK, a signaling protein that B-cells use to grow, travel and stick to other cells. It attaches firmly to BTK and shuts it off.
In lab studies, this slowed the growth of cancerous B-cells and reduced tumor growth.
Zanubrutinib dosage
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Brukinsa comes as capsules and tablets, both taken by mouth once or twice daily, with or without food.
- Swallow whole with water.
- Do not open, break or chew capsules. Do not chew or crush tablets.
- Tablets may be split in half only if your provider prescribes it.
- Missed dose: take it as soon as possible the same day, then resume your normal schedule the next day.
Your prescriber may adjust the dose for liver problems, side effects or certain other medicines.
Dosing details from the FDA-approved label
From the Zanubrutinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (monotherapy or in combination with obinutuzumab)
- 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity
- With or without food; swallow capsules or tablets whole with water; tablets can be split in half as prescribed by the healthcare provider; do not open, break, or chew capsules; do not chew or crush tablets
- Severe hepatic impairment (Child-Pugh class C)
- 80 mg orally twice daily
- No dosage modification recommended for mild or moderate hepatic impairment (Child-Pugh class A or B)
- Coadministration with clarithromycin 250 mg twice daily
- 80 mg twice daily
- Modify or interrupt zanubrutinib dose as recommended for adverse reactions
- Coadministration with clarithromycin 500 mg twice daily
- 80 mg once daily
- Coadministration with posaconazole suspension 100 mg once daily
- 80 mg twice daily
- Coadministration with other strong CYP3A inhibitor
- 80 mg once daily
- After discontinuation of the inhibitor, resume previous dose
- Coadministration with moderate CYP3A inhibitor
- 80 mg twice daily
- After discontinuation of the inhibitor, resume previous dose
- Coadministration with moderate CYP3A inducer
- Avoid concomitant use
- If these inducers cannot be avoided, increase BRUKINSA dose to 320 mg twice daily
- After discontinuation of the inducer, resume previous dose
- Missed dose
- Take as soon as possible on the same day with a return to the normal schedule the following day
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended dosage: 160 mg orally twice daily or 320 mg orally once daily with or without food; swallow whole with water. Tablets can be split in half as prescribed by the healthcare provider. ( 2.1 ) Reduce BRUKINSA dose in patients with severe hepatic impairment. ( 2.2 , 8.7 ) Advise patients not to open, break, or chew capsules. ( 2.1 ) Advise patients not to chew or crush tablets. ( 2.1 ) Manage toxicity using treatment interruption, dose reduction, or discontinuation. ( 2.4 ) 2.1 Recommended Dosage The recommended dosage of BRUKINSA for monotherapy or in combination with obinutuzumab is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity. Capsule Administration Instructions Administer BRUKINSA capsules with or without food [see Clinical Pharmacology (12.3) ] . Advise patients to swallow capsules whole with water and not to open, break, or chew capsules. Tablet Administration Instructions Administer BRUKINSA tablets with or without food [see Clinical Pharmacology (12.3) ]. Advise patients to swallow tablets whole with water and not to chew or crush the tablets. The tablets can be split in half as prescribed by the healthcare provider. Missed Dose If a dose of BRUKINSA is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. 2.2 Dosage Modification for Use in Hepatic Impairment The recommended dosage of BRUKINSA for patients with severe hepatic impairment (Child-Pugh class C) is 80 mg orally twice daily; no dosage modification is recommended for patients with mild or moderate hepatic impairment (Child-Pugh class A or B) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. 2.3 Dosage Modifications for Drug Interactions Recommended dosage modifications of BRUKINSA for drug interactions are provided in Table 1 [see Drug Interactions (7.1) ] . Table 1: Dosage Modifications for Use with CYP3A Inhibitors or Inducers Coadministered Drug Recommended BRUKINSA Dosage (Starting Dose: 160 mg twice daily or 320 mg once daily) Clarithromycin 250 mg twice daily Since clarithromycin 250 mg twice daily acts as a moderate CYP3A inhibitor, it is recommended that patients be administered clarithromycin 250 mg twice daily with 80 mg BRUKINSA twice daily [see Clinical Pharmacology (12.3) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Zanubrutinib side effects
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Common side effects seen in studies include:
Common side effects
- Low neutrophil count (a type of infection-fighting white blood cell)
- Low platelet count
- Upper respiratory tract infection (cold-like illness)
- Bleeding or bruising
- Muscle and joint pain
- Rash
- Diarrhea
- Tiredness
When to get medical help
- Call your doctor or get help right away for signs of serious bleeding, such as black or bloody stools, blood in urine, a severe headache, or bleeding that won't stop.
- Call your doctor for fever, chills, cough or other signs of infection. Serious and even fatal infections have happened.
- Get help for a racing or irregular heartbeat, dizziness, fainting, shortness of breath or chest discomfort. These can be signs of an arrhythmia (abnormal heart rhythm).
- Tell your doctor about new or changing skin spots, and use sun protection. Other cancers, including skin cancers, have developed in people taking this medicine.
- Tell your doctor about signs of liver problems, since serious liver injury can occur.
- Your doctor will check your blood counts regularly because low blood cell counts can be serious.
Zanubrutinib warnings and precautions
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- Bleeding: serious and fatal bleeding has occurred, with or without blood thinners. It should be stopped if bleeding in the brain occurs.
- Infections: serious infections, including hepatitis B reactivation, can occur. Your doctor may consider preventive medicines.
- Low blood counts: regular blood tests are needed.
- Second cancers: including skin cancers. Use sun protection.
- Heart rhythm problems: including atrial fibrillation. Risk may be higher with heart risk factors, high blood pressure or infections.
- Liver injury: liver tests are checked before and during treatment.
- Pregnancy: can cause fetal harm.
Zanubrutinib interactions
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Other medicines can raise or lower zanubrutinib levels.
- Moderate or strong CYP3A inhibitors (such as itraconazole, voriconazole, posaconazole, clarithromycin): raise levels, so the dose is reduced.
- Strong CYP3A inducers (such as rifampin): lower levels and should be avoided.
- Moderate CYP3A inducers: avoid; if unavoidable, the dose may be raised.
- Blood thinners and antiplatelet drugs: may further increase bleeding risk.
Interactions listed in the FDA-approved label
From the Zanubrutinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Moderate and strong CYP3A inhibitors: Coadministration increases zanubrutinib Cmax and AUC, which may increase the risk of BRUKINSA toxicities. Reduce BRUKINSA dosage when coadministered with moderate or strong CYP3A inhibitors.
- Strong CYP3A inducers: Coadministration decreases zanubrutinib Cmax and AUC, which may reduce BRUKINSA efficacy. Avoid coadministration of BRUKINSA with strong CYP3A inducers.
- Moderate CYP3A inducers: Coadministration decreases zanubrutinib Cmax and AUC, which may reduce BRUKINSA efficacy. Avoid coadministration; if these inducers cannot be avoided, increase BRUKINSA dosage to 320 mg twice daily.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP3A Inhibitors: Modify BRUKINSA dose with moderate or strong CYP3A inhibitors as described. ( 2.3 , 7.1 ) CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. ( 2.3 , 7.1 ) 7.1 Effect of Other Drugs on BRUKINSA Table 17: Drug Interactions that Affect Zanubrutinib Moderate and Strong CYP3A Inhibitors Clinical Impact Coadministration with a moderate or strong CYP3A inhibitor increases zanubrutinib C max and AUC [see Clinical Pharmacology (12.3) ] which may increase the risk of BRUKINSA toxicities. Prevention or management Reduce BRUKINSA dosage when coadministered with moderate or strong CYP3A inhibitors [see Dosage and Administration (2.3) ] . Moderate and Strong CYP3A Inducers Clinical Impact Coadministration with a moderate or strong CYP3A inducer decreases zanubrutinib C max and AUC [see Clinical Pharmacology (12.3) ] which may reduce BRUKINSA efficacy. Prevention or management Avoid coadministration of BRUKINSA with strong CYP3A inducers [see Dosage and Administration (2.3) ] . Avoid coadministration of BRUKINSA with moderate CYP3A inducers [see Dosage and Administration (2.3) ] . If these inducers cannot be avoided, increase BRUKINSA dosage to 320 mg twice daily [see Dosage and Administration (2.3) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Zanubrutinib
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- There are no listed contraindications.
- Pregnancy: can harm the baby. Pregnancy testing is recommended before starting, and effective contraception is advised during treatment and for 1 week after.
- Men should avoid fathering a child during treatment and for 1 week after the last dose.
- Breastfeeding: avoid during treatment and for two weeks after the last dose.
- Severe liver impairment: a lower dose is recommended.
- Children: safety and effectiveness have not been established.
- Older adults: those 65 and over had higher rates of serious side effects.
- Upcoming surgery: your doctor may pause treatment for 3 to 7 days before and after.
What Zanubrutinib does in the body
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At the recommended doses, zanubrutinib kept BTK almost fully blocked in blood cells and lymph nodes. It had no clinically relevant effect on heart rhythm timing (QTc interval). In lab blood samples, it reduced some types of platelet clumping, which fits with its bleeding risk.
How your body processes Zanubrutinib
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Zanubrutinib reaches peak levels in about 2 hours, and its half-life is roughly 2 to 4 hours. It is mainly broken down by the liver enzyme CYP3A and leaves mostly through the stool. Food had little effect on the capsules, while a high-fat meal raised levels more with the tablets. Severe liver impairment raised levels substantially, while mild to severe kidney impairment did not matter much.
How to store Zanubrutinib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Zanubrutinib
160 supplements and herbal products have documented interactions with Zanubrutinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 119
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Zanubrutinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Zanubrutinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is zanubrutinib used for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Zanubrutinib available over the counter?
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When was Zanubrutinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Zanubrutinib on HelloPharmacist
Zanubrutinib forms and strengths (how it comes)
Zanubrutinib is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Zanubrutinib inactive ingredients by manufacturer.
Capsule
How this form is used
- Brukinsa capsules can be taken with or without food.
- Swallow Brukinsa capsules whole with water.
- Do not open, break or chew Brukinsa capsules.
Tablet
How this form is used
- Brukinsa tablets can be taken with or without food.
- Swallow Brukinsa tablets whole with water.
- Do not chew or crush Brukinsa tablets.
- Brukinsa tablets can be split in half only if your healthcare provider prescribes it.
Zanubrutinib on the U.S. market: products, makers and brands
How Zanubrutinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Zanubrutinib product records with the FDA, mostly as capsule, tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Brukinsa; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Zanubrutinib is used (Medicaid data)
A general measure of how commonly Zanubrutinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Zanubrutinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Zanubrutinib prescribed? Of the 1,601 medications we measure, Zanubrutinib ranks #1,085 by Medicaid prescriptions — more than 32% of them.
Utilization by Zanubrutinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
zanubrutinib 80 MG Oral Capsule Most dispensed
Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2262440
zanubrutinib 160 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2719220
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Zanubrutinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 13 listed Zanubrutinib NDCs with Medicaid activity.
Compare Zanubrutinib products
A representative set of FDA-listed product records for Zanubrutinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 80 mg | Oral | BeOne Medicines USA, Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 160 mg | Oral | BeOne Medicines USA, Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Zanubrutinib NDCs →
Zanubrutinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Zanubrutinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Zanubrutinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Zanubrutinib FDA approval history
How Zanubrutinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Zanubrutinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Zanubrutinib recalls since July 2021.
✅No Zanubrutinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2262435 2 dose forms · 2 strengths
Look up RxCUI 2262435 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Zanubrutinib supply and shortage status
Whether Zanubrutinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Zanubrutinib brand names
Zanubrutinib is sold under one brand name in the FDA directory — Brukinsa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Zanubrutinib: manufacturers and labelers
One company lists Zanubrutinib products with the FDA. By number of product records, the largest are BeOne Medicines USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Zanubrutinib drug class (RxNorm)
Zanubrutinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Zanubrutinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Beigene Usa, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →