IMBRUVICA 140 MG ( IBRUTINIB ) 120 CAPSULES

WHAT IS IBRUTINIB (IMBRUVICA)?
Ibrutinib is used to treat mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

Ibrutinib is also used to treat chronic graft-versus-host disease.

Ibrutinib is usually given after other treatments have failed.

Ibrutinib may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF IBRUTINIB (IMBRUVICA)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ibrutinib and call your doctor at once if you have:

signs of infection--fever, chills, weakness, mouth sores, cough with mucus, trouble breathing;
signs of bleeding inside your body--dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;
severe or ongoing diarrhea;
chest pain, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
severe headache, blurred vision, pounding in your neck or ears;
easy bruising, unusual bleeding, purple or red spots under your skin;
pale skin, cold hands and feet;
kidney problems--little or no urinating, swelling in your feet or ankles; or
signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Common side effects may include:

diarrhea, nausea;
fever, cough, trouble breathing;
blisters or ulcers in your mouth;
feeling tired;
bruising, rash; or
muscle pain, bone pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT IBRUTINIB (IMBRUVICA)?
This medicine can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have easy bruising, unusual bleeding, or any bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines, or in your brain.

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

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