When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to ibrutinib, or if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• Swallow the capsule whole with a glass of water. Do not open, crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how ibrutinib works. Tell your doctor if you are using any of the following:
  
  • Aprepitant, boceprevir, carbamazepine, crizotinib, diltiazem, imatinib, nefazodone, phenytoin, rifampin, St John's wort, telaprevir, or verapamil
  • Blood thinner (including warfarin) or antiplatelet medicine (including aspirin)
  • Medicine to treat HIV/AIDS (including amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat an infection (including ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole)
• Do not drink grapefruit juice or eat grapefruit or Seville oranges while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment and for 1 month after treatment ends.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, a bleeding disorder, diabetes, high blood pressure, high cholesterol, or a history of heart rhythm problems.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  
  • Heart rhythm problems
  • High blood pressure
  • Increased risk of new cancers, including skin cancer
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
• This medicine may cause diarrhea. Drink plenty of water to help avoid dehydration.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody stools, vomiting blood or material that looks like coffee grounds
• Decrease in how much or how often you urinate, lower back or side pain
• Fast, pounding, or uneven heartbeat, trouble breathing, lightheadedness, dizziness, fainting
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, nausea, vomiting, loss of appetite, stomach pain
• Muscle or joint pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088