Pronunciation: brew-KIN-za
Generic name: zanubrutinib
Dosage form: oral capsule (80 mg)
Drug class: BTK inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 18, 2025.

What is Brukinsa?

Brukinsa is used to treat adults with mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma. It is an oral capsule that is taken once or twice a day.

Brukinsa (zanubrutinib) was first approved in 2019. There is no generic.

FDA approvals and indications

Brukinsa is a prescription oral capsule used to treat adults with:

• Mantle cell lymphoma (MCL) who have received at least 1 prior treatment for their cancer.
• Waldenström’s macroglobulinemia (WM)
• Marginal zone lymphoma (MZL), when the disease has come back or did not respond to treatment (relapsed or refractory) and who have received at least one anti-CD20-based regimen
• Chronic lymphocytic leukemia (CLL)
• Small lymphocytic lymphoma (SLL)
• Follicular lymphoma (FL), in combination with the obinutuzumab, when the disease has come back or did not respond to treatment (relapsed or refractory) and who have received at least 2 prior treatments.

It is not known if this medicine is safe and effective in children.

How does Brukinsa work?

Brukinsa is a targeted treatment, not a chemotherapy drug, and works by directly blocking an enzyme, called Bruton’s tyrosine kinase (BTK), preventing its activity.

• BTK is a signaling molecule for pathways that cause an increase in B cells, a type of white blood cell that makes infection-fighting antibodies.
• Inhibition of BTK reduces the growth and spread of malignant B cells.

Side effects

The most common side effects of Brukinsa are:

• diarrhea or constipation
• low platelet or other blood cell counts
• easy bruising or bleeding
• musculoskeletal pain
• high blood pressure
• a rash
• cold or flu symptoms, such as stuffy nose, sneezing, sore throat, or cough.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Brukinsa. Symptoms may include hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Brukinsa can cause the following serious or life-threatening side effects:

• Severe bleeding. 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
  • increased bruising
  • dizziness
  • weakness
  • confusion
  • vomit blood or vomit that looks like coffee grounds
  • cough up blood or blood clots
  • 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. 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. 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.

Brukinsa can cause fetal harm when administered to a pregnant woman, including malformations. Women should use effective contraception and avoid becoming pregnant while taking Brukinsa and for 1 week after the last dose. Men should avoid fathering a child during treatment and for 1 week after the last dose.

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Before you start treatment with 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
• take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Brukinsa can harm your unborn baby. If you can become pregnant, your healthcare provider may do a pregnancy test before starting treatment with this medicine.

You may need to have a negative pregnancy test before you start using Brukinsa. Females should not become pregnant during treatment and for at least 1 week after the last dose. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.

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

Breastfeeding

It is not known if Brukinsa passes into your breast milk. Do not breastfeed during treatment and for at least 2 weeks after your last dose.

How should I take Brukinsa?

Take exactly as directed by your healthcare provider. 

• Take the capsules once or twice daily as directed.
• Swallowed the capsules whole with a full glass of water. Do not open, break, or chew the capsules.
• May be taken with or without food. 
• The dosage may need to be reduced in those with severe liver disease.
• Take until disease progression or unacceptable toxicity occurs.

Dosing information

Adult dose for MCL, WM, MZL, CLL, SLL, and FL: Brukinsa 160 mg twice a day or 320 mg once a day.

Available as 80 mg capsules.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect Brukinsa?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Common medications that may interact with Brukinsa include:

• Moderate to strong CYP3A Inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, ritonavir, grapefruit juice, erythromycin, or verapamil
• Moderate to strong CYP3A inducers, such as glucocorticoids, rifampin, carbamazepine, phenobarbital, and phenytoin. Avoid coadministration.

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 zanubrutinib works and can cause side effects.

Storage

Store at room temperature in the original container.

Ingredients

Active: zanubrutinib 80mg

Inactive: Silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, gelatine (unspecified), titanium dioxide, and ferrosoferric oxide.

Manufacturer

Brukinsa (zanubrutinib) is manufactured by BeiGene, a global biopharmaceutical company. BeiGene was founded in Beijing, China, and now maintains dual headquarters:

• Beijing, China (where the company was founded in 2010)
• Cambridge, Massachusetts, USA.

Frequently asked questions

• What are the names of the BTK inhibitors?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer