Ibrutinib Oral capsule

What is this medicine?

IBRUTINIB (eye BROO ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenstrom macroglobulinemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• diabetes

• heart disease

• high blood pressure

• high cholesterol

• history of irregular heartbeat

• infection

• liver disease

• recent surgery

• smoke tobacco

• take medicines that treat or prevent blood clots

• an unusual or allergic reaction to ibrutinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Do not take with grapefruit juice or eat Seville oranges. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• boceprevir

• bosentan

• carbamazepine

• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, and voriconazole

• chloramphenicol

• clarithromycin

• conivaptan

• delavirdine

• efavirenz

• enzalutamide

• grapefruit juice or Seville oranges

• indinavir

• isoniazid

• lanreotide or octreotide

• nefazodone

• nelfinavir

• nevirapine

• nicardipine

• phenobarbital

• phenytoin

• rifampin

• ritonavir

• saquinavir

• seville oranges

• st. john's wort

• telaprevir

• telithromycin

• tipranavir

This medicine may also interact with the following medications:

• amiodarone

• amitriptyline

• amprenavir or fosamprenavir

• aprepitant or fosaprepitant

• atazanavir

• bromocriptine

• ciprofloxacin

• crizotinib

• danazol

• darunavir

• dasatinib

• digoxin

• diltiazem

• erythromycin

• fluconazole

• fluvoxamine

• imatinib

• lapatinib

• methotrexate

• mifepristone, RU-486

• quinine

• verapamil

• zafirlukast

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 1 month after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

If you are going to have surgery or any other procedures, tell your doctor you are taking this medicine. Tell your dentist and dental surgeon that you are taking this medicine. You should not have major dental surgery while on this medicine. See your dentist to have a dental exam and fix any dental problems before starting this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

You may need blood work done while you are taking this medicine.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding

• signs or symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose; confusion; trouble speaking or understanding; severe headaches; weakness; or dizziness

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of infection like fever or chills; cough; sore throat; or pain when urinating

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone pain

• diarrhea

• muscle pain

• nausea

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.