ibrutinib

What is the most important information I should know about ibrutinib?

Ibrutinib can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop.

Ibrutinib also affects your immune system. You may get infections more easily, even serious or fatal infections. Tell your doctor if you have a fever, chills, cough, mouth sores, or other signs of infection.

What is ibrutinib?

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

What should I discuss with my healthcare provider before taking ibrutinib?

Tell your doctor if you have ever had:

• an infection;
• liver disease;
• bleeding problems;
• a heart rhythm disorder; or
• risk factors for heart disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol).

Using ibrutinib may increase your risk of developing other types of cancer. Ask your doctor about your specific risk.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ibrutinib .

How should I take ibrutinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Ibrutinib is usually taken until your body no longer responds to the medication.

If you need surgery or dental work, tell your surgeon or dentist you currently use this medicine. You may need to stop for a short time.

Ibrutinib affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

Ibrutinib can make it easier for you to bleed, even from a minor injury. Seek medical attention if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take 2 doses on the same day.

What happens if I overdose?

What should I avoid while taking ibrutinib?

Grapefruit and Seville oranges may interact with ibrutinib and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

What are the possible side effects of ibrutinib?

• 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;
• pale skin, cold hands and feet;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• signs of bleeding inside your body --dizziness, 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;
• signs of infection --fever, chills, weakness, mouth sores, cough with mucus, trouble breathing;
• kidney problems --little or no urinating, swelling in your feet or ankles; or
• signs of tumor cell breakdown --tiredness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, 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 other drugs will affect ibrutinib?

Other drugs may affect ibrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about ibrutinib.