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How does this medication work? What will it do for me?

Zanubrutinib belongs to the class of medications called antineoplastics. Specifically, it is a Bruton's tyrosine kinase (BTK) inhibitor. It is used to treat a type of non-Hodgkin's lymphoma called Waldenström's macroglobulinemia (WM). It is also used to treat other types of cancers, including mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia (CLL).

Lymphomas are cancers that affect the lymphatic system, causing changes to the production of blood cells. In WM, the white blood cells that are produced are abnormal and gradually replace the healthy white blood cells in the body. These abnormal cells produce too much of certain proteins in the body and cause the symptoms of the disease, such as weakness, loss of appetite, fever, sweats, and weight loss.

Zanubrutinib works by blocking a specific protein that helps cancer cells grow and multiply. Blocking this protein helps reduce the number of cancer cells and slow down the cancer spread.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of zanubrutinib is 320 mg daily. This may be taken as 4 of the 80 mg capsules taken by mouth once a day or 2 of the 80 mg capsules taken by mouth twice a day. Your doctor may adjust the dose depending on your side effects.

Zanubrutinib may be taken with food or on an empty stomach. Swallow the capsules whole with some water. Do not chew, dissolve, or open the capsules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

Each size 0 hard gelatin capsule with a white-to-off-white opaque body and cap, marked with "ZANU 80" in black ink, contains 80 mg of zanubrutinib. Nonmedicinal ingredients: ammonium hydroxide (trace), colloidal silicon dioxide, croscarmellose sodium, dehydrated ethanol (trace), gelatin, iron oxide black (trace), isopropyl alcohol (trace), magnesium stearate, microcrystalline cellulose, n-butyl alcohol (trace), propylene glycol (trace), purified water (trace), shellac glaze in ethanol (trace), sodium lauryl sulphate, and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you are allergic to zanubrutinib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • appetite change
  • back pain
  • bloating
  • blurred vision
  • constipation
  • diarrhea
  • dizziness
  • dry eyes
  • dry mouth
  • excessive sweating
  • gas
  • hair loss
  • headache
  • heartburn
  • itching
  • joint pain
  • muscle aches and pain
  • nausea
  • pain in the arms and legs
  • skin redness
  • tiredness
  • vomiting
  • weight changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety
  • chest pain
  • chills
  • dizziness or lightheadedness when rising from a sitting or lying position
  • fainting
  • fever
  • hemorrhoids
  • high blood pressure
  • mouth sores
  • numbness, tingling, and muscle weakness and pain
  • rash
  • ringing, buzzing, hissing, or clicking sounds in the ears
  • shortness of breath
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • swollen hands, feet, or joints
  • symptoms of fluid around the lungs (e.g., chest pain, difficult or painful breathing, cough)
  • symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
  • symptoms of a lung infection (LRTI) (e.g., shortness of breath, cough, chest pain)
  • symptoms of skin cancer (e.g., skin sore, wart, or bump that does not heal)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • waking up in the night to urinate

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of tumour lysis syndrome (e.g., producing less urine, cloudy urine, kidney problems, muscle spasms, nausea, shortness of breath)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Zanubrutinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Bleeding:  This medication may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: Zanubrutinib may cause tiredness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Grapefruit juice and Seville oranges: Grapefruit juice, grapefruit, and Seville oranges can affect how zanubrutinib is removed from the body. Consuming any of these products while taking zanubrutinib may cause the medication to build up in the body and cause harmful side effects. You should not drink grapefruit juice or eat grapefruit at any time while taking this medication.

Infection: Zanubrutinib can also reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Other cancers: Other types of cancer, including forms of skin cancer, can develop while you are taking zanubrutinib. Signs of skin cancer include sores, warts, or bumps that bleed or do not heal, or moles with an irregular shape, border, or colour that are changing shape or are growing. If you notice any of these signs, contact your doctor as soon as possible.

It is also possible to develop other cancers while taking zanubrutinib. Discuss your concerns with your doctor before starting to take this medication.

Surgery: If you are going for surgery, tell your anesthesiologist and surgeon that you are taking zanubrutinib. Depending on the type of surgery and risk of bleeding, you may be asked to stop taking this medication for up to one week before surgery and wait up to one week after surgery to start taking it again.

Pregnancy: Zanubrutinib can cause harm to the developing baby if it is taken during pregnancy. Anyone who could become pregnant must use highly effective birth control measures while taking this medication and for at least one week after the last dose of zanubrutinib, to avoid becoming pregnant while using medication. If you become pregnant while taking this medication, notify your doctor as soon as possible.

Anyone who could impregnate another should use contraception while taking zanubrutinib and for at least 3 months after taking the last dose of medication.

Breast-feeding: It is not known if zanubrutinib passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Avoid breast-feeding while taking this medication and for at least two weeks after the last dose.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over the counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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