Generic Name:  Ibrutinib

Trade Name:  IMBRUVICA^®

For which conditions is this drug approved? IMBRUVICA is indicated for treatment of mantle cell lymphoma (MCL) for chronic lymphocytic leukemia (CLL), both in patients who have received at least one prior therapy;  and for Waldenström’s macroglobulinemia.

What is the mechanism of action? IMBRUVICA is a tyrosine kinase inhibitor. These drugs work by blocking the action of enzymes called tyrosine kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells and blocking them may help keep cancer cells from growing. Specifically, IMBRUVICA blocks the action of a kinase known as Bruton’s tyrosine kinase, or BTK.

How is IMBRUVICA typically given (administered)? IMBRUVICA is given once a day orally at approximately the same time each day. The capsules must be swallowed whole with water and never opened, broken, or chewed.

How are patients typically monitored? Before taking IMBRUVICA, discuss any medical conditions with your healthcare provider. This includes:  a recent or planned surgery or dental procedure, bleeding problems, liver problems, if you are pregnant or plan to become pregnant, are breast feeding or plan to breast feed. IMBRUVICA can harm an unborn baby, so women should not become pregnant while taking this drug. Patients taking IMBRUVICA should be monitored for bleeding, fever and infection, kidney problems, and secondary primary cancers. Blood counts should be taken monthly.

What are the common (occur in 20% or more of patients) side effects of treatment with IMBRUVICA for patients with MCL?

• Thrombocytopenia (lower-than-normal number of platelets in the blood)
• Diarrhea
• Neutropenia (lower-than-normal number of neutrophils, a type of white blood cell)
• Anemia
• Fatigue
• Musculoskeletal pain
• Peripheral edema
• Upper respiratory tract infection
• Nausea
• Bruising
• Dyspnea (difficult, painful breathing or shortness of breath)
• Constipation
• Rash
• Abdominal pain
• Vomiting
• Decreased appetite 

What are the common (occur in 20% or more of patients) side effects of treatment with IMBRUVICA for patients with CLL?

• Thrombocytopenia (lower-than-normal number of platelets in the blood)
• Diarrhea
• Bruising
• Neutropenia (lower-than-normal number of neutrophils, a type of white blood cell)
• Anemia
• Upper respiratory tract infection
• Fatigue
• Musculoskeletal pain
• Rash
• Fever
• Constipation
• Peripheral edema
• Joint pain
• Nausea
• Stomatitis (inflammation or irritation of the mucous membranes in the mouth)
• Sinus infection
• Dizziness 

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome. 

What can patients do to help alleviate or prevent discomfort and side effects? Take IMBRUVICA exactly as your healthcare provider tells you to take it (once daily and swallowed whole with water) and take it 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, then take your next dose at your regular time the next day. Do not take two doses of IMBRUVICA on the same day to make up for a missed dose. Tell your healthcare provider about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how IMBRUVICA works and can cause side effects.

Are there any special precautions patients should be aware of before starting treatment? 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.

When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. This includes persistent diarrhea and signs of bleeding, such as blood in stools or urine and prolonged or uncontrolled bleeding.

What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.