Ibrutix (Ibrutinib) 140 MG – 120 Capsules

• To treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) who have already been treated with at least one other chemotherapy medication,
• To treat people with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes),
• To treat people with Waldenstrom’s macroglobulinemia (WM; a slow-growing cancer that begins in certain white blood cells in your bone marrow),
• To treat people with marginal zone lymphoma (MZL; a slow growing cancer that begins in a type of white blood cells that normally fights infection) who have already been treated with a certain type of chemotherapy medication,
• And to treat people with chronic graft vs host disease (cGVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow] that may start a while after the transplant and last for a long time) after being treated unsuccessfully with 1 or more medications.

Ibrutix is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Ibrutix comes as a capsule and a tablet to take by mouth. It is usually taken once daily. Take ibrutinib at around the same time every day.  Most importantly, follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take ibrutinib exactly as directed.  After that, do not take more or less of it or take it more often than prescribed by your doctor.As a result receiving obinutuzumab (Gazyva) injection or rituximab (Rituxan) injection, your doctor may tell you to take your dose of imbrutinib before you receive your injection.

Consequently, your doctor may decrease your dose, or interrupt or discontinue your treatment. This depends on how well the medication works for you and the side effects you experience. For instance, talk to your doctor about how you are feeling during your treatment. Continue to take ibrutinib even if you feel well. Do not stop taking ibrutinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Tell your doctor if any of these symptoms are severe or do not go away:

• Diarrhoea
• Nausea
• Vomiting
• Stomach pain
• Heartburn or indigestion
• Decreased appetite
• Excessive tiredness or weakness
• Muscle, bone and joint pain
• Muscle spasms
• Swelling of the hands, feet, ankles, or lower legs
• Rash
• Sores in the mouth and throat
• Difficulty falling asleep or staying asleep
• Cough, runny or stuffed nose
• Blurred vision
• Dry or watery eyes

Serious side effects

If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Swelling of the face, throat, tongue, lips, and eyes
• Difficulty swallowing or breathing
• Unusual bruising or bleeding
• Pink, red, or dark brown urine
• Bloody or black, tarry stools
• Nose bleeding
• Bloody vomit; or vomiting blood or brown material that resembles coffee grounds
• Fast or irregular heartbeat
• Shortness of breath
• Dizziness, lightheadedness or feeling faint
• Headache (that lasts a long time)
• Fever, chills, cough, red, warm skin, or other signs of infection
• Confusion
• Changes in your speech
• Decreased urination
• Painful, frequent, or urgent urination

Ibrutix may increase your risk of developing certain types of cancer including cancer of the skin or other organs. Talk to your doctor about the risks of taking ibrutinib.