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What is Brukinsa?

What is Brukinsa?

Brukinsa (zanubrutinib) is a brand-name prescription medication manufactured by BeiGene USA, Inc. It is FDA-approved to treat certain blood cancers that affect a type of white blood cell called B lymphocytes or B cells. It’s taken by mouth, typically once or twice daily. Brukinsa was granted approval under an accelerated program given its promising response rates in early trials.

Read on as we discuss what Brukinsa is used for, its side effects, precautions, and other important information you need to know.

Brukinsa FAQs

What is Brukinsa approved for?

Brukinsa (zanubrutinib) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with:

  • Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, who have received at least one prior therapy

  • Waldenström’s macroglobulinemia

  • Relapsed or refractory marginal zone lymphoma (MZL) for people whose cancer came back after or didn’t respond well to other anticancer medications

  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

How does Brukinsa work?

The conditions Brukinsa is approved to treat are caused by cancerous B cells. Your body produces a protein called Bruton tyrosine kinase (BTK) that signals these B cells to grow and spread. The active ingredient in Brukinsa, zanubrutinib, is a type of kinase inhibitor called a BTK inhibitor. By blocking the activity of BTK, Brukinsa slows the growth of cancer cells and causes the death of cancerous B cells.

What are the possible side effects of Brukinsa?

The most common side effects of Brukinsa from clinical trials include:

  • High blood sugar levels

  • Low white blood cell counts including low neutrophils (neutropenia)

  • Low red blood cell counts

  • Low platelet count

  • Muscle or joint pain

  • Upper respiratory tract infection

  • Bruising and bleeding

  • Rash

  • Increased creatinine levels

  • Fatigue

  • Increased liver enzymes

  • Diarrhea

  • Increased potassium levels

  • Nausea/vomiting

Brukinsa can rarely cause serious side effects such as:

  • Severe, life-threatening allergic reactions (swelling of your tongue or throat, hives, and trouble breathing)

  • Serious bleeding, including brain and stomach bleeds

  • Serious infections and reactivation of the hepatitis B virus (HBV)

  • Increased risk of other cancers

  • Heart rhythm problems

These are not all of the possible side effects of Brukinsa. You should always seek medical advice from your healthcare professional for any questions or concerns about your medical condition or treatment. You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Are there any drug interactions with Brukinsa?

When Brukinsa is taken along with other drugs, it can change how Brukinsa works or make some side effects more likely or severe. You should ask your healthcare provider if any of the prescription drugs, over-the-counter (OTC) drugs, supplements, or vitamins you take may interact with Brukinsa, including:

  • Antibiotics such as clarithromycin, rifampin, and erythromycin

  • Antifungal medications such as fluconazole, itraconazole, ketoconazole, and voriconazole

  • Medications used to treat HIV such as indinavir and ritonavir

  • Hepatitis C medications such as telaprevir

  • Anticonvulsants such as carbamazepine, phenobarbital, and phenytoin

  • Blood pressure medications such as diltiazem and verapamil

What should you tell your doctor before starting Brukinsa?

Before starting Brukinsa, be sure your healthcare provider is aware of all your medical conditions, including:

  • Liver problems

  • Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias)

  • High blood pressure

  • Are pregnant, plan on becoming pregnant as Brukinsa may harm your unborn baby

  • Are breastfeeding or plan to breastfeed as it is not recommended while using Brukinsa

How do you take Brukinsa?

Be sure to read the full Prescribing Information including Patient Information that comes with Brukinsa. Take Brukinsa exactly as your doctor prescribes it to you. Do not change your dose of Brukinsa or stop taking it without talking to your doctor.

Brukinsa is typically taken once or twice daily, with or without food. You should swallow Brukinsa capsules whole with a glass of water. Do not open, break, or chew the capsules.

If you miss a dose of this medication, take the missed dose immediately on the same day, then start back on your normal schedule the next day.

What precautions are there with Brukinsa?

Serious and sometimes fatal bleeding problems such as hemorrhage are common with Brukinsa. You should let your healthcare provider know if you have symptoms of serious bleeding such as bleeding that takes a long time to stop, black or bloody stools, blood in the urine, vomit that looks like coffee grounds, confusion, fainting, and weakness.

Serious infections were also reported in clinical studies of Brukinsa. Notify your healthcare provider of any signs of an infection so it can be treated immediately.

Low blood counts can occur with Brukinsa so your healthcare provider may perform labs to monitor these levels while on this medication.

Other malignancies have developed in people taking Brukinsa, including skin cancers and non-skin cancers. Use a sunscreen or other sun protection to help reduce this risk.

You should watch for signs and symptoms of arrhythmias and report any to your healthcare provider. Symptoms include heart palpitations, lightheadedness, shortness of breath, dizziness, fainting, and chest pain.

Brukinsa can cause harm to your unborn baby. If you can become pregnant, you should take a pregnancy test before beginning Brukinsa treatment. Females should use effective contraception (birth control) to avoid pregnancy during treatment and for at least 1 week after the last dose of Brukinsa. Males should use effective contraception (birth control) to avoid getting their female partners pregnant during treatment and for at least 1 week after the last dose of Brukinsa.

What is the dose for Brukinsa?

The recommended dose of Brukinsa is 160 mg orally twice daily or 320 mg orally once daily until the disease progresses or you develop unacceptable toxicity. Your dose of Brukinsa should be reduced if you have severe liver disease.

Is Brukinsa a chemo drug?

Brukinsa is a type of targeted therapy and not chemotherapy. Targeted therapies such as Brukinsa stop cancer from spreading by blocking cancer cells from dividing and making new cells. Chemotherapy, however, directly kills cancer cells that have already been made.

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