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ibrutinib

Generic Name: ibrutinib (eye BROO ti nib)
Brand Name: Imbruvica

What is ibrutinib?

Ibrutinib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Ibrutinib is used to treat mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).

Ibrutinib is usually given after at least one other medication has been tried without success.

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

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: Flashback: FDA Drug Approvals 2013

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

You should not use ibrutinib if you are allergic to it.

To make sure ibrutinib is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease; or

  • bleeding or blood clotting disorder such as hemophilia.

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

FDA pregnancy category D. Do not use ibrutinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether ibrutinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take ibrutinib?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. Drink plenty of liquids while you are taking ibrutinib.

Take the medicine at the same time each day.

Do not crush, chew, break, or open an ibrutinib capsule. Swallow it whole.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using ibrutinib. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ibrutinib?

Grapefruit and grapefruit juice may interact with ibrutinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking ibrutinib. Also avoid eating Seville oranges and marmalades made with these.

Ibrutinib side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ibrutinib and call your doctor at once if you have:

  • severe or ongoing diarrhea;

  • severe weakness or dizziness, confusion, problems with speech, prolonged headache;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • red or pink urine;

  • confusion, loss of appetite, vomiting, pain in your side or lower back;

  • little or no urinating, swelling, rapid weight gain;

  • fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common side effects may include:

  • nausea, stomach pain, diarrhea, constipation, loss of appetite;

  • muscle or joint pain;

  • tired feeling;

  • swelling in your hands or feet; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Side effects (in more detail)

Ibrutinib dosing information

Usual Adult Dose for Lymphoma:

560 mg orally once a day

Use: The treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

420 mg orally once a day

Use: The treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

What other drugs will affect ibrutinib?

Other drugs may interact with ibrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about ibrutinib.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-03-05, 2:15:25 PM.

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