Ibrutinib (eye-BROO-ti-nib)

Treats chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), WaldenstrÖm macroglobulinemia (WM), and chronic graft-versus-host disease (cGHVD).

Brand Name(s):

Imbruvica

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Liquid, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• Swallow the capsule or tablet whole with a glass of water. Do not open, crush, break, or chew it.
• Measure the oral liquid medicine with the provided oral dosing syringe.
• 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. Take the missed dose only if it is the same day as the scheduled dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away any unused oral liquid 60 days after opening the bottle.

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 digoxin, efavirenz, erythromycin, ketoconazole, methotrexate, posaconazole, rifampin, voriconazole, or a blood thinner (including warfarin).
• 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 month after the last dose.
• Do not breastfeed during treatment and for 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, a bleeding disorder, diabetes, high blood pressure, high cholesterol, any infection, 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:
  • Increased risk of bleeding, which may be life-threatening
  • Increased risk of infection (including progressive multifocal leukoencephalopathy [PML], pneumonia)
  • Serious heart problems, (including heart rhythm problems, heart failure)
  • High blood pressure
  • Increased risk of new cancers, including skin cancer
  • Liver problems
  • 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
• Blistering, peeling, red skin rash
• Bloody stools or urine, severe headache, vomiting blood or material that looks like coffee grounds
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate, lower back or side pain
• Fast, slow, pounding, or uneven heartbeat, lightheadedness, dizziness, fainting
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Trouble breathing, cold sweat, bluish-colored skin
• Unusual bleeding, bruising, or weakness

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

• Diarrhea, constipation
• 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