IMBRUVICA™ is a prescription medicine used to treat people with:

• Mantle cell lymphoma (MCL) who have received at least one prior treatment
• Chronic lymphocytic leukemia (CLL) who have received at least one prior treatment

It is not known if IMBRUVICA™ is safe and effective in children.

What should I tell my healthcare provider before taking IMBRUVICA™?

Before you take IMBRUVICA™, tell your healthcare provider about all of your medical conditions, including if you:

• had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA™ for any planned medical, surgical, or dental procedure.
• have bleeding problems
• have liver problems
• are pregnant or plan to become pregnant. IMBRUVICA™ can harm your unborn baby. You should not become pregnant while taking IMBRUVICA™.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA™ or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA™ with certain other medicines may affect how IMBRUVICA™ works and can cause side effects.

How should I take IMBRUVICA™?

• Take IMBRUVICA™ exactly as your healthcare provider tells you to take it.
• Take IMBRUVICA™ 1 time a day.
• Swallow IMBRUVICA™ capsules whole with a glass of water. Do not open, break, or chew IMBRUVICA™ capsules.
• Take IMBRUVICA™ at about the same time each day.
• If you miss a dose of IMBRUVICA™ take it as soon as you remember on the same day. Take your next dose of IMBRUVICA™ at your regular time on the next day. Do not take 2 doses of IMBRUVICA™ on the same day to make up for a missed dose.

What should I avoid while taking IMBRUVICA™?

• You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) while you are taking IMBRUVICA™. These products may increase the amount of IMBRUVICA™ in your blood.

What are the possible side effects of IMBRUVICA™?

IMBRUVICA™ may cause serious side effects, including:

• Bleeding problems can happen during treatment with IMBRUVICA™ that can be serious. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, feel dizzy or weak, confusion, change in your speech, or a headache that lasts a long time. Your risk of bleeding may increase if you are also taking a blood thinner medicine.
• Infections can happen during treatment with IMBRUVICA™. Infections can be serious and may lead to death. Tell your healthcare provider if you have fever, chills, or any other signs or symptoms of an infection while taking IMBRUVICA™.
• Decrease in blood cell counts. Your healthcare provider should do monthly blood tests to check your blood counts.
• Kidney problems. Kidney failure and death have happened with IMBRUVICA™ treatment. Drink fluids during treatment with IMBRUVICA™ to help prevent too much fluid loss (dehydration). Your healthcare provider should do blood tests to check how well your kidneys are working.
• Second primary cancers. New cancers have happened in people who have been treated with IMBRUVICA™, including cancers of the skin or other organs.

The most common side effects of IMBRUVICA™ in MCL include: low blood platelet count, diarrhea, low white blood cell count, low red blood cell count, fatigue, muscle and bone pain, swelling of legs and feet, upper respiratory tract infection, nausea, bruising, shortness of breath, constipation, rash, stomach (abdomen) pain, vomiting, and decreased appetite.

The most common side effects of IMBRUVICA™ in CLL include: low blood platelet count, diarrhea, bruising, low white blood cell count, low red blood cell count, upper respiratory tract infection, fatigue, muscle and bone pain, rash, fever, constipation, swelling of legs and feet, joint pain, nausea, mouth sores, sinus infection, and dizziness.

Diarrhea is a common side effect in people who take IMBRUVICA™. Tell your healthcare provider if you have diarrhea that does not go away

General information about the safe and effective use of IMBRUVICA™

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA™ for a condition for which it was not prescribed. Do not give IMBRUVICA™ to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA™ that is written for health professionals.

These are not all the possible side effects of IMBRUVICA™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please review the full Important Product Information by clicking here.