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ibrutinib

Pronunciation: eye BROO ti nib

Brand: Imbruvica

Imbruvica

slide 1 of 1, Imbruvica,

140 mg, capsule, white, imprinted with ibr 140 mg

 Image of Imbruvica
slide 1 of 1
    

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

This medicine can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have easy bruising, unusual bleeding, or any bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines, or in your brain.

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

What is ibrutinib?

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

Ibrutinib is used to treat certain types of non-Hodgkin lymphoma, including mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia, and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in people with or without 17p deletion.

Ibrutinib is also used to treat marginal cell lymphoma and chronic graft-versus-host disease.

Ibrutinib is sometimes given when other medicines have not been effective.

Ibrutinib was approved to treat mantle cell and marginal lymphomas by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

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

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

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

Tell your doctor if you have ever had:

  • liver or kidney disease;
  • an active infection;
  • a bleeding or blood clotting disorder;
  • a heart rhythm disorder;
  • risk factors for heart disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol)
  • surgery; or
  • a condition for which you take a blood thinner (warfarin, Coumadin, Jantoven).

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

Ibrutinib can harm an unborn baby. Both men and women using this medicine should use birth control to prevent pregnancy. The use of this medicine by either parent may cause harm to the baby.

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

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

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.

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

Ibrutinib is usually taken once per day until your body no longer responds to the medication. Take the medicine at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

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.

Call your doctor if you have severe or ongoing diarrhea. You can easily become dehydrated while taking ibrutinib.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Store in the original package at room temperature, away from moisture and heat.

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?

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

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?

Get emergency medical help if you have 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;
  • chest pain, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
  • pale skin, easy bruising, purple or red pinpoint spots under your skin;
  • little or no urinating, swelling in your feet or ankles;
  • signs of infection --fever, chills, weakness, mouth sores, skin sores, cough with mucus, wheezing, trouble breathing;
  • signs of tumor cell breakdown --confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth; or
  • signs of bleeding inside your body --dizziness, weakness, 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.

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.


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.

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.

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