Product Description:

• IMBRUVICA is a medicine againstcancer, which contains the active substance ibrutinib.


• It belongs to a group of drugs called protein kinase inhibitors.

What IMBRUVICA is used for:

It is used to treat the following types of blood cancer in adults:

• Mantle cell lymphoma (MCL), a type of cancer that affects the lymph nodes, when the disease has returned or treatment has not worked.


• Chronic lymphocytic leukemia(CLL), a type of cancer that affects white blood cells called lymphocytes, which also includes the lymph nodes.


• IMBRUVICA is used in patients who have not been treated for CLL before or when the disease has returned or the treatment has not had an effect.


• Waldenström's macroglobulinemia(WM), a type of cancer that affects white blood cells called lymphocytes.It is used in patients who have not been treated forWMin the past or when the disease has come back or treatment has not worked, or in patients who cannot be given chemotherapy together with an antibody.

How to use:

• Always use this medicine exactly as your doctor, pharmacist or nurse has told you.


• Contact a doctor, pharmacist or nurse if you are unsure.

How much to take:

• Mantle cell lymphoma (MCL)
  The recommended dose of IMBRUVICA is 560 mg once daily.


• Chronic lymphocytic leukemia(CLL) /Waldenström's macroglobulinemia(WM)


• The recommended dose of IMBRUVICA is 420 mg once daily.


• Your doctor may need to adjust your dose.

Taking this medicine:

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


• Take the tablets at about the same time each day.


• Swallow the tablets whole.Do not crush or chew them.

If you take too much IMBRUVICA:

• Talk to a doctor or see a hospital immediately if you take too much IMBRUVICA.


• Take the tablets and medicine leaflet with you.

If you forget to take IMBRUVICA:

• If you have forgotten a dose, it can be taken as soon as possible on the same day, and the usual dosing schedule is continued the next day.


• You should not take a double dose to replace a missed dose.


• Ask your doctor, pharmacist or nurse if you are unsure when to take your next dose.

If you stop treatment with IMBRUVICA:

• Do not stop treatment with this medicine unless your doctor tells you to do so.


• Ask your doctor, pharmacist or nurse if you have any questions about the use of this medicine.

How IMBRUVICA works:

• IMBRUVICA works by blocking "Bruton's tyrosine kinase", a protein in the body that helps cancer cells grow and survive in MCL, CLL andWM.


• By blocking this protein, IMBRUVICA helps to kill and reduce the number of cancer cells.It also slows down the development of cancer.

Warnings and precautions:

Do not use IMBRUVICA:

• If you are allergic to ibrutinib or any of the other ingredients of this medicine.


• If you are taking a natural medicine called st. John's wort, used for depression.


• Talk to your doctor, pharmacist or nurse before using this medicine if you are unsure.

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

• If you have ever had unusual bruising or bleeding or are taking medicines or dietary supplements that increase the risk of bleeding.


• If you have an irregular heartbeat or have had an irregular heartbeat or severe heart failure, or if you notice any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near-fainting, chest pain or leg swelling


• If you have liver problems, including if you have or have ever hadhepatitis Binfection(a liver infection)


• If you havehigh blood pressure


• If you have recently had an operation, especially if this may affect your absorption of food or medicines from the stomach or intestines.


• If you are scheduled to have an operation - the doctor may ask you to stop taking IMBRUVICA for a short period (3 to 7 days) before and after the operation


• If you have kidney problems.


• Talk to your doctor, pharmacist or nurse before or while using this medicine if any of the above apply to you (or you are unsure).


• While you are using IMBRUVICA, tell your doctor immediately if you or others notice any of the following in you:memory loss, trouble thinking, difficulty walking or vision loss - this may be due to a very rare but serious brain infection that can be fatal (progressive multifocal leukoencephalopathyor PML).

You must contact a doctor immediately if you or someone around you notices any of the following happening to you:

• suddennumbnessor weakness in the legs or arms (especially if it happens on only one side of the body), sudden confusion, difficulty speaking or understanding what others say, vision loss, difficulty walking, lack of balance or coordination, sudden severe headache with no known cause.These can be signs and symptoms of a stroke.


• You must contact a doctor immediately if you experience pain in the upper left part of the abdomen, under the left part of the chest or in the outermost left shoulder (these may be symptoms of a ruptured spleen) after you have stopped taking IMBRUVICA.

Heart effect:

• Treatment with IMBRUVICA can affect the heart, especially if you already have heart disease, such as heart rhythm problems, heart failure,high blood pressure, diabetes or old age.


• The impact can be severe and can lead to death, sometimes sudden death.


• Your heart function will be checked before and during treatment with IMBRUVICA.


• You must contact a doctor immediately if you experience shortness of breath, breathing difficulties when lying down, swelling of the feet, ankles or legs and weakness/fatigue during treatment with IMBRUVICA - these may be signs of heart failure.


• You may experience viral, bacterial or fungal infections during treatment with IMBRUVICA.


• Contact a doctor if you develop afever, chills, feeling weak, confusion, body aches,coldor flu symptoms, feeling tired or experiencing shortness of breath, or yellowing of the skin or eyes (jaundice).


• This may be a sign of aninfection.


• Hemophagocytic lymphohistocytosis:
  There have been rare cases of excessive activation of white blood cells with inflammation (haemophagocytic lymphohistocytosis), which can be fatal if not diagnosed and treated early.You must contact a doctor immediately if you get more symptoms such asfever, swollen glands, bruises or skin rash.

Tests and checks before and during treatment:

Tumor lysis syndrome(TLS):

• Unusual amounts of substances in the blood due to the rapid breakdown of cancer cells have occurred during cancer treatment, and sometimes also without treatment.


• This can cause changes in kidney function, abnormal heart rhythm or convulsions.


• The doctor or other healthcare professional can take blood tests to check forTLS.

Lymphocytosis:

• Laboratory tests may show an increase in white blood cells (called "lymphocytes") in your blood during the first few weeks of treatment.


• This is expected and may last a few months.


• This does not necessarily mean that the blood cancer is worsening.


• The doctor will check the number of blood cells before or during treatment, and in rare cases it may be necessary to give you another medicine.


• Talk to the doctor about what the test results mean.

Liver-related events:

• Your doctor will do some blood tests to check that your liver is working properly, or that you do not have a liver infection, known as viral hepatitis, or thathepatitis Bhas become active again, which can be fatal.

Children and youth:

• IMBRUVICA should not be used in children and adolescents.

Other medicines and IMBRUVICA

• Talk to your doctor or pharmacist if you use, have recently used or plan to use other medicines.


• This also applies to over-the-counter medicines, natural medicines and dietary supplements.


• This is because IMBRUVICA can affect how other medicines work.


• Certain other medicines can also affect how IMBRUVICA works.


• IMBRUVICA can make you bleed more easily.

This means that you must inform the doctor if you use other agents that may increase the risk of bleeding.This includes:

• Acetylsalicylic acidand non-steroidalanti-inflammatorydrugs (nsaids), such as ibuprofen and naproxen


• Blood thinners such as warfarin, heparin and other medicines against blood clots


• Dietary supplements that can increase the risk of bleeding, such as fish oil, vitamin E and linseed.


• Talk to your doctor, pharmacist or nurse before using IMBRUVICA if any of the above applies to you (or you are unsure).


• Also inform the doctor if you use any of these medicines- The effect of IMBRUVICA or other medicines can be affected if you use 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 HIVinfection– ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir, atazanavir or fosamprenavir


• Medicines to preventnauseaand vomiting in connection with chemotherapy - aprepitant


• Medicines for depression - nefazodone


• Medicines called kinase inhibitors to treat other types of cancer – crizotinib or imatinib


• Medicines called calcium antagonists forhigh blood pressureor chest pain – diltiazem or verapamil


• Medicines calledstatinsto treat highcholesterol- rosuvastatin


• Heart medicines/antiarrhythmics– amiodarone or dronedarone


• Medicines to prevent seizures or to treatepilepsyor medicines to treat a painful condition in the face calledtrigeminal neuralgia- carbamazepine or phenytoin.


• Talk to your doctor, pharmacist or nurse before using IMBRUVICA if any of the above applies to you (or you are unsure).


• If you are taking digoxin, a medicine used for heart problems, or methotrexate, a medicine used to treat other types of cancer and which suppresses the activity of the immune system (eg in rheumatoidarthritisor psoriasis), it should be taken at least 6 hours before or after IMBRUVICA.

Taking IMBRUVICA with food:

• Do not take IMBRUVICA with grapefruit or pomeranus (bitter orange)- this includes eating, drinking juice or taking a food supplement that may contain it.


• This is because it can increase the amount of IMBRUVICA in the blood.

Pregnancy and breastfeeding:

• You must not become pregnant while using this medicine.


• IMBRUVICA should not be used during pregnancy.


• There is no information on the safety of using IMBRUVICA in pregnant women.


• Women of childbearing potential must use a highly effective method of contraception while taking and for up to three months after taking IMBRUVICA to avoid becoming pregnant while being treated with IMBRUVICA.


• Inform the doctor immediately if you become pregnant.


• You should not breast-feed while using this medicine.

Driving and using machines:

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

IMBRUVICA contains lactose:

• IMBRUVICA contains lactose (a type of sugar).


• If your doctor has told you that you have an intolerance to some types of sugar, you should contact your doctor before taking this medicine.

Ingredients:

• The active ingredient is IBRUTINIB.

IMBRUVICA 140 mgfilm-coated tablets:

• Each tablet contains 140 mg ibrutinib.