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AstraZeneca

Imbruvica
ibrutinib

Package leaflet: Information for the patient


IMBRUVICA 140 mg hard capsules

ibrutinib


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

side effects not listed in this leaflet. See section 4.


What is in this leaflet

  1. What IMBRUVICA is and what it is used for

  2. What you need to know before you take IMBRUVICA

  3. How to take IMBRUVICA

  4. Possible side effects

  5. How to store IMBRUVICA

  6. Contents of the pack and other information


  1. What IMBRUVICA is and what it is used for What IMBRUVICA is

    IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. It belongs to a class of medicines called protein kinase inhibitors.


    What IMBRUVICA is used for

    It is used to treat the following blood cancers in adults:

    • Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.

    • Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes. IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.

    • Waldenström’s macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.


      How IMBRUVICA works

      In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer.


  2. What you need to know before you take IMBRUVICA Do not take IMBRUVICA

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

    • if you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.

      Warnings and precautions

      Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:

    • 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 IMBRUVICA”)

    • if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs

    • if you have liver problems, including if you ever had or now have a hepatitis B infection (a liver infection)

    • if you have high blood pressure

    • if you have recently had any surgery, especially if this might affect how you absorb food or medicines from your stomach or gut

    • if you are planning to have any surgery– your doctor may ask you to stop taking IMBRUVICA for a short time (3 to 7 days) before and after your surgery

    • if you have kidney problems.


      If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before or while taking this medicine (see section “Possible side effects”).


      When taking IMBRUVICA, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).


      Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause. These may be signs and symptoms of stroke.


      Tell your doctor immediately if you develop left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of rupture of the spleen) after you stop taking IMBRUVICA.


      Tell your doctor immediately if you notice breathlessness, difficulty breathing when lying down, swelling of the feet, ankles or legs and weakness/tiredness (these may be signs of heart failure) during treatment with IMBRUVICA.


      You may experience viral, bacterial, or fungal infections during treatment with IMBRUVICA. Contact your doctor if you have fever, chills, weakness, confusion, body aches, cold or flu symptoms, feel tired or feel short of breath, yellowing of the skin or eyes (jaundice). These could be signs of an infection.


      Haemophagocytic lymphohistiocytosis

      There have been rare reports of excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis), which can be fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your doctor immediately.


      Tests and check-ups before and during treatment

      Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened 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.


      Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “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 or during the treatment and in rare cases they may need to give you another medicine. Talk to your doctor about what your test results mean.


      Events related to the liver: Your doctor will do some blood tests to check whether your liver is working properly or that you do not have a liver infection, known as viral hepatitis, or whether hepatitis B has become active again, which could be fatal.


      Children and adolescents

      IMBRUVICA should not be used in children and adolescents. This is because it has not been studied in these age groups.


      Other medicines and IMBRUVICA

      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 IMBRUVICA may affect the way some other medicines work. Also some other medicines can affect the way IMBRUVICA works.


      IMBRUVICA 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:

    • acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen

    • blood thinners such as warfarin, heparin or other medicines for 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 IMBRUVICA.


      Also tell your doctor if you take any of the following medicines – The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:

    • medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin, ciprofloxacin, erythromycin or rifampicin

    • medicines for fungal infections – posaconazole, ketoconazole, itraconazole, fluconazole or voriconazole

    • medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir, atazanavir, or fosamprenavir

    • medicines to prevent nausea and vomiting associated with chemotherapy - aprepitant

    • medicines for depression - nefazodon

    • medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib

    • medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or verapamil

    • medicines called statins to treat high cholesterol - rosuvastatin

    • heart medicines/anti-arrhythmics – amiodarone or dronedarone

    • medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia – carbamazepine or phenytoin.


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


      If you are taking digoxin, a medicine used for heart problems, or methotrexate, a medicine used to treat other cancers and to reduce the activity of the immune system (e.g., for rheumatoid arthritis or psoriasis), it should be taken at least 6 hours before or after IMBRUVICA.

      IMBRUVICA with food

      Do not take IMBRUVICA with grapefruit or Seville oranges (bitter oranges) – this includes eating them, drinking the juice or taking a supplement that might contain them. This is because it can increase the amount of IMBRUVICA in your blood.


      Pregnancy and breast-feeding

      Do not get pregnant while you are taking this medicine. IMBRUVICA should not be used during pregnancy. There is no information about the safety of IMBRUVICA in pregnant women.


      Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.


    • Tell your doctor immediately if you become pregnant.

    • Do not breast-feed while you are taking this medicine.


      Driving and using machines

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


      IMBRUVICA contains sodium

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


  3. How to take IMBRUVICA


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


    How much to take

    Mantle cell lymphoma (MCL)

    The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.


    Chronic lymphocytic leukaemia (CLL)/Waldenström’s macroglobulinaemia (WM)

    The recommended dose of IMBRUVICA is three capsules (420 mg) once a day. Your doctor may adjust your dose.

    Taking this medicine

    • Take the capsules orally (by mouth) with a glass of water.

    • Take the capsules about the same time each day.

    • Swallow the capsules whole. Do not open, break or chew them.


      If you take more IMBRUVICA than you should

      If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away. Take the capsules and this leaflet with you.


      If you forget to take IMBRUVICA

    • If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.

    • 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 IMBRUVICA

      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.


  4. Possible side effects


    Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:


    Stop taking IMBRUVICA 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 – 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), or lung, or skin

    • bruising or increased tendency of bruising

    • mouth sores

    • feeling dizzy

    • headache

    • constipation

    • feeling or being sick (nausea or vomiting)

    • diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine

    • skin rash

    • painful arms or legs

    • back pain or joint pain

    • muscle cramps, aches or spasms

    • low number of cells that help blood clot (platelets), very low number of white blood cells – shown in blood tests

    • an increase in the number or proportion of white blood cells shown in blood tests

    • high level of “uric acid” in the blood (shown in blood tests), which may cause gout

    • swollen hands, ankles or feet

    • high blood pressure

    • increased level of “creatinine” in the blood.


      Common (may affect up to 1 in 10 people)

    • severe infections throughout the body (sepsis)

    • infections of the urinary tract

    • nose bleeds, small red or purple spots caused by bleeding under the skin

    • blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop from an injury

    • heart failure

    • fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath, chest discomfort (symptoms of heart rhythm problems)

    • low white blood cell counts with fever (febrile neutropenia)

    • non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer

    • blurred vision

    • redness of the skin

    • inflammation within the lungs that may lead to permanent damage

    • breaking of the nails

    • weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy).


      Uncommon (may affect up to 1 in 100 people)

    • liver failure, including events with fatal outcome

    • severe fungal infections

    • confusion, headache with slurred speech or feeling faint – these could be signs of serious internal bleeding in your brain

    • unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)

    • allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)

    • inflammation of the fatty tissue underneath the skin

    • temporary episode of decreased brain or nerve function caused by loss of blood flow, stroke

    • bleeding in the eye (in some cases associated with loss of vision)

    • painful skin ulceration (pyoderma gangrenosum) or red, raised painful patches on the skin, fever and an increase in white blood cells (these may be signs of acute febrile neutrophilic dermatosis or Sweet’s syndrome).


      Rare (may affect up to 1 in 1,000 people)

    • severely increased white blood cell count that may cause cells to clump together.


      Not known (frequency cannot be estimated from available data)

    • severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).


      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.


  5. How to store IMBRUVICA


    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 bottle label 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.


  6. Contents of the pack and other information What IMBRUVICA contains

What IMBRUVICA looks like and contents of the pack

IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side. The capsules are provided in a plastic bottle with a child resistant polypropylene closure. Each bottle contains either 90 or 120 capsules. Each pack contains one bottle.


Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30

B-2340 Beerse

Belgium


Manufacturer

Janssen Pharmaceutica NV Turnhoutseweg 30

B-2340 Beerse Belgium


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


België/Belgique/Belgien Janssen-Cilag NV Tel/Tél: +32 14 64 94 11

janssen@jacbe.jnj.com

Lietuva

UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88

lt@its.jnj.com


България

„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00

jjsafety@its.jnj.com

Luxembourg/Luxemburg

Janssen-Cilag NV Tél/Tel: +32 14 64 94 11

janssen@jacbe.jnj.com


Česká republika Janssen-Cilag s.r.o. Tel: +420 227 012 227

Magyarország Janssen-Cilag Kft. Tel.: +36 1 884 2858

janssenhu@its.jnj.com


Danmark

Janssen-Cilag A/S Tlf: +45 4594 8282

jacdk@its.jnj.com

Malta

AM MANGION LTD. Tel: +356 2397 6000


Deutschland

Janssen-Cilag GmbH Tel: +49 2137 955 955

jancil@its.jnj.com

Nederland

Janssen-Cilag B.V. Tel: +31 76 711 1111

janssen@jacnl.jnj.com


Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410

ee@its.jnj.com

Norge

Janssen-Cilag AS Tlf: +47 24 12 65 00

jacno@its.jnj.com


Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH Tel: +43 1 610 300

España

Janssen-Cilag, S.A. Tel: +34 91 722 81 00

contacto@its.jnj.com

Polska

Janssen-Cilag Polska Sp. z o.o. Tel.:+48 22 237 60 00


France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

medisource@its.jnj.com

Portugal

Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600


Hrvatska

Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700

jjsafety@JNJCR.JNJ.com

România

Johnson & Johnson România SRL Tel: +40 21 207 1800


Ireland

Janssen Sciences Ireland UC Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o. Tel.: +386 1 401 18 00

Janssen_safety_slo@its.jnj.com


Ísland

Janssen-Cilag AB c/o Vistor hf

Sími: +354 535 7000

janssen@vistor.is

Slovenská republika Johnson & Johnson, s.r.o. Tel: +421 232 408 400


Italia

Janssen-Cilag SpA

Tel: 800 688 777 / +39 02 2510 1

janssenita@its.jnj.com

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

jacfi@its.jnj.com


Κύπρος

Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700

Sverige

Janssen-Cilag AB Tfn: +46 8 626 50 00

jacse@its.jnj.com


Latvija

UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561

lv@its.jnj.com

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC Tel: +44 1 494 567 444


This leaflet was last revised in