Brukinsa 80 mg capsulas duras

Patient Information Leaflet

BRUKINSA hard capsules of80mg

zanubrutinib

This medicine is subject to additional monitoring, which will speed up the detection of any new information about its safety. You can contribute by reporting any side effects you may experience. The final part of section4includes information on how to report these side effects.

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

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

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What BRUKINSA is and what it is used for

2.What you need to know before you start taking BRUKINSA

3.How to take BRUKINSA

4.Possible side effects

5.Storage of BRUKINSA

6.Contents of the pack and additional information

BRUKINSA is a cancer medication that contains the active ingredient zanubrutinib. It belongs to a class of medications called protein kinase inhibitors. This medication works by blocking a Bruton's tyrosine kinase inhibitor, a protein in the body that helps cancer cells grow and survive. By blocking this protein, BRUKINSA reduces the number of cancer cells and slows down cancer progression.

BRUKINSA is used to treat Waldenström 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 medication is used when the disease has relapsed, 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. It is a type of cancer that also affects B lymphocytes or B cells. 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 various 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 medication is used when the disease has relapsed or treatment has not worked.

BRUKINSA is also used to treat chronic lymphocytic leukemia (CLL), another type of B cell cancer that affects lymph nodes. This medication is used in patients who have not received treatment for CLL previously, in case of disease relapse, or if the disease 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 lymph nodes, the spleen, and bone marrow. BRUKINSA is taken along with another medication called obinutuzumab when the disease has relapsed or when previous medications have not worked.

Do not take BRUKINSA

if you are allergic to zanubrutinib or any of the other ingredients in this medicine (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take BRUKINSA:

• if you have ever had unusual bleeding or bruising or if you are taking medicines or supplements that increase the risk of bleeding (see the section“Other medicines and BRUKINSA”); if you have recently had surgery or are planning to have surgery, your doctor may ask you to stop taking BRUKINSA for a short period of time (3to7days) before and after the surgery or dental procedure;
• 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 near-fainting, chest pain, or swollen legs;
• if you have been told that you are at increased 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, symptoms of a cold or flu, feeling tired or short of breath, yellowing of the skin or eyes (jaundice);;
• if you have ever had or could have hepatitis B. This is because BRUKINSA can reactivate hepatitis B. Before starting treatment, patients will be carefully examined by their doctor to detect signs of this infection.
• if you have liver or kidney problems;
• if you have recently had surgery, especially if it could affect the way you absorb food or medicine from your stomach or intestines;
• if you have recently had low counts of red blood cells, white blood cells, or platelets in your blood;
• if you have had other cancers in the past, such as skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma), use sun protection.

If you find yourself in any of the above circumstances, (or are unsure), consult your doctor, pharmacist, or nurse before starting to take this medicine.

Tests and controls before and during treatment

Analyses or blood tests may reveal lymphocytosis, an increase in white blood cells ("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 administer another medicine. Discuss what the results of your blood tests mean with your doctor.

Tumor lysis syndrome (TLS):during cancer treatment, and sometimes even without treatment, unusual levels of chemicals in the blood have been observed caused by the rapid breakdown of cancer cells. This can lead to kidney function impairment, irregular heartbeat, or seizures. Your doctor or other healthcare professional will be able to perform blood tests to detect TLS.

Children and adolescents

BRUKINSA should not be used in children and adolescents, as it is unlikely to be effective.

Other medicines and BRUKINSA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines, herbal medicines, and supplements. This is because BRUKINSA may affect the way some medicines work. Additionally, some medicines may affect the way BRUKINSA works.

BRUKINSA may cause bleeding more easily.This means that you should inform your doctor if you are taking other medicines that increase the risk of bleeding. This includes medicines such as:

• aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen,
• blood thinners, 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 find yourself in any of the above circumstances, (or are unsure), consult your doctor, pharmacist, or nurse before starting to take BRUKINSA.

Also, inform your doctor if you are taking any of the following medicines. The effects of BRUKINSA or other medicines may be influenced if you take BRUKINSA with any of the following medicines:

• antibiotics for 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
• medicines that inhibit kinase 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 facial condition called trigeminal neuralgia:carbamazepine, mephenytoin, phenytoin
• medicines for migraines and cluster headaches: dihydroergotamine, ergotamine
• medicines for excessive sleepiness and other sleep disorders: modafinil
• medicines for psychosis and Tourette's disorder: pimozide
• medicines called immunosuppressants: cyclosporine, sirolimus, tacrolimus

Use of BRUKINSA with food

Oranges and grapefruits should be consumed with caution around the time of taking 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 unknown whether BRUKINSA may harm the fetus.

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

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

Driving and operating machinery

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

BRUKINSA contains sodium

This medicine contains less than1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult 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 approximately at the same time each day.

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

If you take more BRUKINSA than you should

If you take more BRUKINSA than you should, consult a doctor immediately. Bring the capsule container and this leaflet with you.

If you forget to take BRUKINSA

If you miss a dose, take it at the next scheduled time 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 medication twice a day, in the morning and in the evening, and forget to take it in the morning, take the next dose in the evening. Do not take a double dose to make up for the missed capsules. If unsure, consult your doctor, pharmacist, or nurse about when to take the next dose.

If you interrupt treatment with BRUKINSA

Do not stop treatment with this medication unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• hives, difficulty breathing, swelling of the face, lips, tongue, or throat: you may be experiencing an allergic reaction to the medicine.

Inform your doctor immediately if you notice any of the following side effects:

Very common(may affect more than1person in every10)

• fever, chills, body aches, feeling tired, symptoms of the flu or common cold, shortness of breath, frequent and painful urination: these may be symptoms of an infection (viral, bacterial, or fungal). These may include upper respiratory tract infections, sinus infections, or pneumonia.
• bruising 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 a replacement of fluids and salt 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 should perform blood tests during BRUKINSA treatment to check the number of blood cells.

Common(may affect up to1person in every10)

• swelling of the hands, ankles, or feet
• nasal bleeding
• itching on the skin
• small spots of bleeding under the skin
• rapid heart rate, absent 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 to1person in every100people)

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

Unknown frequency

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational reporting system included in theAppendix V.*. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of BRUKINSA

• The active ingredient is zanubrutinib. Each hard capsule contains80mg of zanubrutinib.
• The other components are:

- capsule content: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate (E487), anhydrous colloidal silica, magnesium stearate (see section2“BRUKINSA contains sodium”).

- capsule body: gelatin and titanium dioxide (E171).

- printing ink: shellac (E904), iron oxide black (E172) and propylene glycol (E1520).

Appearance of BRUKINSA and contents of the pack

BRUKINSA is a white or off-white hard capsule with “ZANU80” printed in black ink on one side. The capsules are packed in a plastic bottle with a child-resistant closure. Each bottle contains120hard capsules.

Marketing Authorisation Holder

BeiGene Ireland Ltd.

10Earlsfort Terrace

Dublín2

D02T380

Ireland

Phone:+35315667660

Email[email protected]

Responsible Person

Millmount Healthcare Limited

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

K32YD60

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 obtain more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet: November 2023

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.