Zanubrutinib

Generic name: zanubrutinib
Brand name: Brukinsa
Dosage form: oral capsule
Drug class: BTK inhibitors

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 12, 2024.

What is zanubrutinib?

Zanubrutinib is a chemotherapy drug used to treat certain types of B-cell cancers. These cancers affect B-lymphocytes, a type of white blood cell that helps you fight off infection. They occur when your body makes too many abnormal B-cells.

Zanubrutinib belongs to a class of drugs called kinase inhibitors. Zanubrutinib is a second-generation irreversible BTK (Bruton tyrosine kinase) inhibitor that works by blocking the action of a protein called Bruton's tyrosine kinase, which signals B-cells to grow and multiply. This stops cancer from growing in your body.

Zanubrutinib was approved by the US Food and Drug Administration (FDA) in 2019.

What is zanubrutinib used for?

Zanubrutinib is a prescription medicine used to treat adults with:

• Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
• Waldenström's macroglobulinemia (WM)
• Mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer
• Marginal zone lymphoma (MZL) that has returned or did not respond to treatment and 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. 

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

What should I tell my doctor before taking zanubrutinib?

Before taking zanubrutinib, 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 zanubrutinib 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.

How should I take zanubrutinib?

• Take zanubrutinib exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking zanubrutinib unless your healthcare provider tells you to.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking zanubrutinib if you develop certain side effects.
• Take zanubrutinib with or without food.
• Swallow zanubrutinib capsules whole with a glass of water. Do not open, break, or chew the capsules.

What happens if I miss a dose?

If you miss a dose of zanubrutinib, take it as soon as you remember on the same day. Return to your normal schedule the next day.

Dosing information

• The recommended dose of zanubrutinib is 160 mg orally twice daily or 320 mg once daily. Swallow whole with water and with or without food.
• Do not open, break, or chew capsules.
• In patients with severe hepatic impairment, the dose of zanubrutinib should be reduced.
• See full prescribing information for further details about zanubrutinib dosing.

What are the side effects of zanubrutinib?

Zanubrutinib may cause serious side effects, including:

• Bleeding problems (hemorrhage) that 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 a fever, chills, or flu-like symptoms.
• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with zanubrutinib, but can also be severe. Your healthcare provider should do blood tests during treatment with zanubrutinib to check your blood counts.
• Second primary cancers. New cancers have happened in people during treatment with zanubrutinib, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with zanubrutinib. Use sun protection when you are outside in sunlight.
• Heart rhythm problems (atrial fibrillation and atrial flutter). 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

The most common side effects of zanubrutinib include:

• decreased white blood cells
• upper respiratory tract infection
• decreased platelet count
• bleeding
• rash
• muscle or joint pain

These are not all the possible side effects of zanubrutinib.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Interactions

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Zanubrutinib can harm your unborn baby. If you can become pregnant, your healthcare provider may do a pregnancy test before starting treatment with zanubrutinib.

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

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

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

Storage

• Store zanubrutinib capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Zanubrutinib comes in a bottle with a child-resistant cap.

Keep zanubrutinib and all medicines out of the reach of children.

What are the ingredients in zanubrutinib?

Active ingredient: zanubrutinib

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

The capsule shell contains edible black ink, gelatin, and titanium dioxide.

Manufacturer

Zanubrutinib is distributed and marketed under the brand name Brukinsa by BeiGene USA, Inc.

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