WHAT IS IMBRUVICA™?

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 we