BRUKINSA 80 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

BRUKINSA Hard Capsules of80mg

zanubrutinib

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this section 4 will provide information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is BRUKINSA and what is it used for
2. What you need to know before you take BRUKINSA
3. How to take BRUKINSA
4. Possible side effects
5. Storage of BRUKINSA
6. Contents of the pack and other information

1. What is BRUKINSA and what is it used for

BRUKINSA is a cancer medicine that contains the active substance zanubrutinib. It belongs to a class of medicines called kinase inhibitors. This medicine works by blocking a tyrosine kinase inhibitor of Bruton, a protein in the body that helps cancer cells to grow and survive. By blocking this protein, BRUKINSA reduces the number of cancer cells and delays the worsening of cancer.

BRUKINSA is used to treat Waldenström's macroglobulinemia (also known as lymphoplasmacytic lymphoma), a cancer that affects a type of white blood cell called B cells that produce too much of a protein called IgM.

This medicine is used when the disease has come back, the treatment has not worked, or in patients who cannot receive chemotherapy along with an antibody.

BRUKINSA is also used for the treatment of marginal zone lymphoma. This is a type of cancer that also affects B cells or B lymphocytes. In marginal zone lymphoma, abnormal B lymphocytes multiply too quickly and live too long, which can cause the enlargement of certain organs that are part of the body's natural defenses, such as lymph nodes and the spleen. Abnormal B lymphocytes can also affect several organs, such as the stomach, salivary glands, thyroid, eyes, lungs, bone marrow, and blood. Patients may experience fever, weight loss, fatigue, and night sweats, but also symptoms that depend on where the lymphoma develops. This medicine is used when the disease has come back or the treatment has not worked.

BRUKINSA is also used to treat chronic lymphocytic leukemia (CLL), another type of B-cell cancer that affects the lymph nodes. This medicine is used in patients who have not received treatment for CLL before, in case the disease comes back, or if it has not responded to previous treatment.

BRUKINSA is also used to treat follicular lymphoma (FL). FL is a slow-growing cancer that affects B lymphocytes. FL causes an excess of these B lymphocytes in the lymph nodes, spleen, and bone marrow. BRUKINSA is taken along with another medicine called obinutuzumab when the disease has come back or when the medicines used before have not worked.

2. What you need to know before you take BRUKINSA

Do not take BRUKINSA

if you are allergic to zanubrutinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking BRUKINSA:

• if you have ever had unusual bruising or bleeding, or if you are taking medicines or supplements that increase the risk of bleeding (see the section “Other medicines and BRUKINSA”); if you have had recent surgery or are scheduled to have surgery, your doctor may ask you to stop taking BRUKINSA for a short period (3 to 7 days) before and after surgery or dental procedures;
• if you have an irregular heartbeat or a history of irregular heartbeat or severe heart failure, or if you experience any of the following symptoms: shortness of breath, weakness, dizziness, fainting, or chest pain;
• if you have been told that you are at a higher risk of infections. You may experience viral, bacterial, or fungal infections during treatment with BRUKINSA, with the following possible symptoms: fever, chills, weakness, confusion, body aches, cold or flu-like symptoms, feeling tired or short of breath, yellowing of the skin or eyes (jaundice);
• if you have ever had or may have hepatitis B. This is because BRUKINSA may reactivate hepatitis B. Before starting treatment, patients will be carefully examined by their doctor for signs of this infection.
• if you have liver or kidney problems;
• if you have recently had surgery, especially if it could affect the way your stomach or intestine absorbs food or medicines;
• if you have recently had low red blood cell, infection-fighting cell, or platelet counts in your blood;
• if you have had other carcinomas in the past, such as skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma), use sun protection.

If you are in any of the above situations (or are unsure), talk to your doctor, pharmacist, or nurse before you start taking this medicine.

Tests and checks before and during treatment

Lab tests or blood tests may show an increase in white blood cells called lymphocytes in the blood in the first few weeks of treatment. This effect is expected and may last for several months. This does not necessarily mean that the blood cancer is getting worse. Your doctor will check your blood counts before and during treatment, and in rare cases, may need to give you another medicine. Talk to your doctor about what your test results mean.

Tumor lysis syndrome (TLS): during cancer treatment, and sometimes even without treatment, unusual levels of chemicals in the blood have been seen due to the rapid breakdown of cancer cells. This can lead to changes in kidney function, irregular heartbeat, or seizures. Your doctor or other healthcare professional may do blood tests to check for TLS.

Children and adolescents

BRUKINSA should not be used in children and adolescents because it is unlikely to work.

Other medicines and BRUKINSA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, herbal medicines, and supplements. This is because BRUKINSA may affect the way some medicines work. Also, some medicines may affect the way BRUKINSA works.

BRUKINSA may cause bleeding more easily.This means you should tell your doctor if you take other medicines that increase the risk of bleeding. These include medicines such as:

• acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen,
• anticoagulants, such as warfarin, heparin, and other medicines for the treatment or prevention of blood clots,
• supplements that may increase the risk of bleeding, such as fish oil, vitamin E, or flaxseed.

If you are in any of the above situations (or are unsure), talk to your doctor, pharmacist, or nurse before you start taking BRUKINSA.

Also, tell your doctor if you take any of the following medicines.The effects of BRUKINSA or other medicines may be affected if you take BRUKINSA with any of the following medicines:

• antibiotics to treat bacterial infections: ciprofloxacin, clarithromycin, erythromycin, nafcillin, or rifampicin
• medicines for fungal infections: fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• medicines for HIV infection: efavirenz, etravirine, indinavir, lopinavir, ritonavir, telaprevir
• medicines to prevent nausea and vomiting associated with chemotherapy: aprepitant
• medicines for depression: fluvoxamine, St. John's Wort
• kinase inhibitor medicines for the treatment of other cancers: imatinib
• medicines for high blood pressure or chest pain: bosentan, diltiazem, verapamil
• medicines for the heart/antiarrhythmics: digoxin, dronedarone, quinidine
• medicines to prevent seizures, to treat epilepsy, or to treat a painful condition of the face called trigeminal neuralgia: carbamazepine, mephenytoin, phenytoin
• medicines for migraines and cluster headaches: dihydroergotamine, ergotamine
• medicines for excessive sleepiness and other sleep problems: modafinil
• medicines for psychosis and Tourette's disorder: pimozide
• medicines for anesthesia: alfentanil, fentanyl
• medicines called immunosuppressants: cyclosporine, sirolimus, tacrolimus

Using BRUKINSA with food

Grapefruit and bitter oranges should be consumed with caution around the time you take BRUKINSA. This is because they may increase the amount of BRUKINSA in your blood.

Pregnancy and breastfeeding

Do not become pregnant while taking this medicine. Do not use BRUKINSA during pregnancy. It is not known if BRUKINSA can harm the fetus.

Women of childbearing age must use a very effective method of contraception during treatment with BRUKINSA and for at least one month after treatment. A barrier method of contraception (e.g., condoms) should be used with hormonal contraceptives such as birth control pills or contraceptive devices.

• Tell your doctor immediately if you become pregnant.
• Do not breastfeed your child while taking this medicine. BRUKINSA may pass into breast milk.

Driving and using machines

You may feel tired or dizzy after taking BRUKINSA, and this may affect your ability to drive or use machines.

BRUKINSA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially “sodium-free”.

3. How to take BRUKINSA

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is 320 mg (4 capsules) per day, either 4 capsules once a day or 2 capsules in the morning and 2 capsules in the evening.

Your doctor may adjust the dose.

Take the capsules by mouth with a glass of water with food or between meals.

Take the capsules at about the same time each day.

BRUKINSA works best when swallowed whole. Therefore, swallow the capsules whole. Do not open, break, or chew them.

If you take more BRUKINSA than you should

If you take more BRUKINSA than you should, talk to a doctor immediately. Bring the pack of capsules and this leaflet with you.

If you forget to take BRUKINSA

If you miss a dose, take it in the next scheduled hour and return to your normal schedule the next day. If you take BRUKINSA once a day, take the next dose the next day. If you take the medicine twice a day, in the morning and at night, and you miss the morning dose, take the next dose at night. Do not take a double dose to make up for the missed capsules. If you are unsure, talk to your doctor, pharmacist, or nurse about when to take the next dose.

If you stop taking BRUKINSA

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking BRUKINSA and tell a doctor immediately if you notice any of the following side effects:

• a rash with itching, difficulty breathing, swelling of the face, lips, tongue, or throat: you may be having an allergic reaction to the medicine.

Tell a doctor immediately if you notice any of the following side effects:

Very common(may affect more than 1 in 10 people)

• fever, chills, body aches, feeling tired, flu or cold-like symptoms, shortness of breath, frequent or painful urination: these may be symptoms of an infection (caused by a virus, bacteria, or fungus). These can include infections of the nose, sinuses, or throat (upper respiratory tract infections), pneumonia, or urinary tract infections.
• bruises or increased tendency to bruise; contusions
• bleeding
• muscle and bone pain
• skin rash
• lung infection (lower respiratory tract infection)
• dizziness
• diarrhea; your doctor may need to give you fluids and salts or another medicine
• cough
• fatigue
• high blood pressure
• constipation
• blood in the urine
• decrease in the number of blood cells in the blood test. Your doctor will need to do blood tests during treatment with BRUKINSA to check the number of cells in your blood.

Common(may affect up to 1 in 10 people)

• swelling of the hands, ankles, or feet
• nasal bleeding
• itching of the skin
• small bleeding spots under the skin
• fast heart rate, lack of pulse, weak or irregular pulse, dizziness, shortness of breath, chest discomfort (symptoms of heart rhythm problems)
• weakness
• low white blood cell count with fever (febrile neutropenia)

Uncommon side effects(may affect up to 1 in 100 people)

• reactivation of hepatitis B (if you have had hepatitis B, it may come back)
• intestinal bleeding (blood in the stool)
• during cancer treatment, and sometimes even without treatment, unusual levels of chemicals in the blood have been seen due to the rapid breakdown of cancer cells (tumor lysis syndrome)

Frequency not known

• redness and peeling of the skin over a large area of the body, which may be accompanied by itching or pain (generalized exfoliative dermatitis)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of BRUKINSA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of BRUKINSA

• The active ingredient is zanubrutinib. Each hard capsule contains 80 mg of zanubrutinib.
• The other components are:

• capsule content: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate (E487), colloidal anhydrous silica, magnesium stearate (see section 2 "BRUKINSA contains sodium").
• capsule body: gelatin and titanium dioxide (E171).
• printing ink: shellac (E904), black iron oxide (E172), and propylene glycol (E1520).

Appearance of BRUKINSA and container contents

BRUKINSA is a hard white or off-white capsule with "ZANU 80" marked in black ink on one side. The capsules are provided in a plastic bottle with a child-resistant closure. Each bottle contains 120 hard capsules.

Marketing authorization holder

BeiGene Ireland Ltd.

10 Earlsfort Terrace

Dublin 2

D02 T380

Ireland

Tel. +353 1 566 7660

E-mail [email protected]

Manufacturer

Millmount Healthcare Limited

Block-7, City North Business Campus, Stamullen, Co Meath,

K32 YD60

Ireland

BeiGene Germany GmbH

Georges-Köhler-Str. 2, 79539 Lörrach

Germany

BeiGene Netherlands B.V.

Evert van de Beekstraat 1, 104

1118 CL Schiphol

Netherlands

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of last revision of this prospectus: November 2023

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.