Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - brukinsa

Document Subject

Generated Narrative: MedicinalProductDefinition mpc2d0e28fbe1723337dab22fe407d0234

identifier: http://ema.europa.eu/identifier/EU/1/21/1576/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: BRUKINSA 80 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c2d0e28fbe1723337dab22fe407d0234

identifier: http://ema.europa.eu/identifier/EU/1/21/1576/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - brukinsa

Attesters

What is in this leaflet

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

BRUKINSA is an anticancer medicine that contains the active substance zanubrutinib. It belongs to a class of medicines called protein kinase inhibitors. This medicine works by blocking Bruton's tyrosine kinase, 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 the worsening of the cancer.

BRUKINSA is used to treat Waldenstr m s macroglobulinaemia (also known as lymphoplasmacytic lymphoma), a cancer affecting a type of white blood cells called B lymphocytes or B cells that make too much of a protein called IgM. This medicine is used when the disease has come back, or treatment has not worked or in patients who cannot have chemotherapy together with an antibody.

BRUKINSA is also used to treat marginal zone lymphoma. This is a type of cancer that also affects B lymphocytes or B cells. In marginal zone lymphoma, the abnormal B cells multiply too quickly and live for too long. This may cause enlargement of organs that are part of body s natural defences such as lymph node and spleen. The abnormal B cells may also affect various organs, such as stomach, salivary gland, thyroid, eyes, lungs, bone marrow and blood. Patients may have fever, weight loss, tiredness and night sweats, but also symptoms that depend on where the lymphoma develop. This medicine is used when the disease has come back, or treatment has not worked.

BRUKINSA is also used to treat chronic lymphocytic leukaemia (CLL), another type of cancer affecting B cells that involves the lymph nodes. This medicine is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to previous treatment. BRUKINSA is also used to treat follicular lymphoma (FL). FL is a slow growing cancer that affects the B lymphocytes. When you have FL, you have too many of these B lymphocytes in your lymph nodes, spleen, and bone marrow. BRUKINSA is taken together with another medicine called obinutuzumab when the disease has come back or when previously used medicines have not been effective.

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 taking BRUKINSA:

• if you have ever had unusual bruising or bleeding or are on any medicines or supplements that increase your risk of bleeding (see section Other medicines and BRUKINSA ). If you have had recent surgery or plan to have surgery, your doctor may ask you to stop taking BRUKINSA for a short time (3 to 7 days) before and after your surgery or dental procedure
• if you have an irregular heartbeat or have a history of irregular heartbeat or severe heart failure, or if you have any of the following: shortness of breath, weakness, dizziness, light- headedness, fainting or near fainting, chest pain or swollen legs
• if you have ever been advised that you are at 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 symptoms, feel tired or feel short of breath, yellowing of the skin or eyes (jaundice).
• if you have ever had or might have hepatitis B. This is because BRUKINSA could cause hepatitis B to become active again. Patients will be carefully checked by their doctor for signs of this infection before treatment is started
• if you have liver or kidney problems
• if you have recently had any surgery, especially if it might affect how you absorb food or medicines from your stomach or gut
• if you recently had low counts of red blood cells, infection-fighting cells or platelets in your blood
• if you had other carcinomas in the past including skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma). Please use sun protection

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.

Tests and check-ups before and during treatment
Laboratory tests may show lymphocytosis, an increase in white blood cells (lymphocytes) in your blood in the first few weeks of treatment. This is expected and may last for a few months. This does not necessarily mean that your blood cancer is getting worse. Your doctor will check your blood counts before and during the treatment and in rare cases the doctor may give you another medicine. Talk to your doctor about what your test results mean. Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have occurred during treatment of cancer and sometimes even without treatment. This may lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or another healthcare provider 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. This includes medicines obtained without a prescription, herbal medicines and supplements. This is because BRUKINSA may affect the way some medicines work. Also, some medicines can affect the way BRUKINSA works.

BRUKINSA may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes medicines such as:

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

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking BRUKINSA.

Also tell your doctor if you take any of the following medicines The effects of BRUKINSA or other medicines may be influenced if you take BRUKINSA together 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
• medicine to prevent nausea and vomiting associated with chemotherapy - aprepitant
• medicines for depression fluvoxamine, St. John s wort
• medicine called kinase inhibitors for treatment of other cancers imatinib
• medicines for high blood pressure or chest pain bosentan, diltiazem, verapamil
• heart medicines/anti-arrhythmics 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
• medicine for extreme sleepiness and other sleep problems - modafinil
• medicine for psychosis and Tourette disorder - pimozide
• medicines for anaesthesia alfentanil, fentanyl
• medicines called immunosuppressive agents ciclosporin, sirolimus, tacrolimus

BRUKINSA with food

Grapefruit or Seville oranges (bitter oranges) should be consumed with caution around the time you take BRUKINSA. This is because they can increase the amount of BRUKINSA in your blood.

Pregnancy and breast-feeding

Do not get pregnant while you are taking this medicine. BRUKINSA should not be used during pregnancy. It is not known if BRUKINSA will harm your unborn baby.

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

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

Driving and using machines

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

BRUKINSA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 320 mg (4 capsules) each day, either as 4 capsules once daily or 2 capsules in the morning and 2 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 about the same time each day. BRUKINSA works best when it is 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 straight away. Take the capsule packet and this leaflet with you.

If you forget to take BRUKINSA

If you miss a dose, take it at the next scheduled time with a return to the normal schedule. If you take BRUKINSA once per day, take your next dose the following day. If you take the medicine twice a day, in the morning and in the evening and you forgot to take it in the morning, take your next dose in the evening. Do not take a double dose to make up for a forgotten dose. If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.

If you stop taking BRUKINSA

Do not stop taking this medicine unless your doctor tells you. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

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

• itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat you may be having an allergic reaction to the medicine.

Tell a doctor straight away 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, cold or flu symptoms, being short of breath, frequent and painful urination these could be signs of an infection (viral, bacterial or fungal). These could include infections of the nose, sinus or throat (upper respiratory tract infection), pneumonia, or urinary tract.
• bruising or increased tendency of bruising; contusions
• bleeding
• muscle and bone aches
• skin rash
• infection of the lung (lower respiratory tract infection)
• dizziness
• diarrhoea; your doctor may need to give you a fluid and salt replacement or another medicine
• cough
• fatigue
• high blood pressure
• constipation
• Dizziness
• blood in urine
• blood tests showing a reduced number of blood cells. Your doctor should do blood tests during treatment with BRUKINSA to check the number of your blood cells.

Common (may affect up to 1 in 10 people):

• swollen hands, ankles or feet
• nosebleed
• itching of the skin
• small bleeding spots under the skin
• fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath, chest discomfort (symptoms of heart rhythm problems)
• weakness
• low white blood cell count with fever (febrile neutropenia)

Uncommon (may affect up to 1 in 100 people):

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

Unknown:

• redness and shedding of skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis generalized)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What BRUKINSA contains

• The active substance is zanubrutinib. Each hard capsule contains 80 mg of zanubrutinib.

• The other ingredients are:

• capsule content: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate (E487), silica colloidal anhydrous and magnesium stearate. See section 2 BRUKINSA contains sodium .

• capsule shell: gelatin and titanium dioxide (E171)

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

What BRUKINSA looks like and contents of the pack

BRUKINSA is a white to off-white hard capsule of 22 mm in length, marked with ZANU 80 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 Authorisation Holder

BeiGene Ireland Ltd. 10 Earlsfort Terrace Dublin 2 D02 TIreland Tel. +353 1 566 7E-mail bg.ireland@beigene.com

Manufacturer

BeiGene Switzerland GmbH Dutch Branch Evert van de Beekstraat 1, 1118 CL Schiphol The Netherlands

BeiGene Germany GmbH Georges-K hler-Str. 2 79539 L rrach, Germany

BeiGene Netherlands B.V. Evert van de Beekstraat 1, 1118 CL Schiphol The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien BeiGene Belgium SRL T l/Tel: 0800 774 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD
Te .: +359 (0)2 4942 Luxembourg/Luxemburg BeiGene France sarl T l/Tel: 0800 85 esk republika Swixx Biopharma s.r.o. Tel: +420 242 434 Magyarorsz g Swixx Biopharma Kft. Tel.: +36 1 9206 Danmark BeiGene Sweden AB Tlf: 808 10 Malta Swixx Biopharma S.M.S.A. Tel: +30 214 444 9Deutschland Beigene Germany GmbH Tel: 0800 200 8Nederland BeiGene Netherlands B.V. Tel: 08000 233 Eesti Swixx Biopharma O
Tel: +372 640 1Norge BeiGene Sweden AB Tlf: 800 31
Swixx Biopharma . .
Tel: +30 214 444 9 sterreich BeiGene Austria GmbH Tel: 0800 909 Espa a BeiGene Spain, SLU Tel: 9000 31 Polska BeiGene Poland sp. z o. o. Tel.: 8000 80 France BeiGene France sarl T l: 080 554 3Portugal BeiGene Portugal, Unipessoal Lda Tel: 800 210 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Ireland BeiGene UK Ltd Tel: 1800 812 Rom nia Swixx Biopharma S.R.L Tel: +40 37 1530 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 2355 sland BeiGene Sweden AB S mi: 800 4Slovensk republika Swixx Biopharma s.r.o.
Tel: +421 2 20833 Italia BeiGene Italy Srl Tel: 800 588 Suomi/Finland BeiGene Sweden AB Puh/Tel: 0800 774
Swixx Biopharma . .
Tel: +30 214 444 9Sverige BeiGene Sweden AB Puh/Tel: 0200 810 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 Northern Ireland BeiGene UK Ltd Tel: 0800 917 6This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: