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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PLGB 53789/0002.
BRUKINSA 80 mg hard capsules
BRUKINSA 80 mg hard capsules
zanubrutinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma), a cancer affecting a type of white blood cells called B lymphocytes 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 the body’s natural defences such as lymph nodes 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 develops. 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.
if you are allergic to zanubrutinib or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before taking BRUKINSA:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
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.
BRUKINSA should not be used in children and adolescents, because it is unlikely to work.
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:
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:
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.
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.
You may feel tired or dizzy after taking BRUKINSA, which may affect your ability to drive or use machines.
BRUKINSA 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, talk to a doctor straight away. Take the capsule packet and this leaflet with you.
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 capsule. If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.
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.
itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.
Very common (may affect more than 1 in 10 people) -
Common (may affect up to 1 in 10 people) -
Uncommon (may affect up to 1 in 100 people) -
Unknown
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 to the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
BRUKINSA is a white to off-white hard capsule, 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.
This leaflet was last revised in October 2023
Other sources of information
Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency web site: www.mhra.gov.uk