ibrutinib

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Pronunciation: eye BROO ti nib

Brand: Imbruvica

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.

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 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 sometimes given when other medicines have not been effective.

Ibrutinib was approved to treat mantle cell lymphoma by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, it has not been shown that ibrutinib can improve symptoms or lengthen survival time in people with this type of lymphoma.

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.

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

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

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

Do not use ibrutinib if you are pregnant. It could harm the unborn baby. You may need to have a negative pregnancy test before starting this treatment.

Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Ibrutinib use by either parent may cause birth defects. Keep using birth control for at least 1 month after your last dose of ibrutinib.

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.

Ibrutinib is usually taken once per day. 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 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 extra medicine to make up the missed dose.

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 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.

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:

  • chest pain and severe dizziness, fast or irregular heartbeats, trouble breathing, feeling like you might pass out;
  • severe or ongoing diarrhea;
  • fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • severe weakness or dizziness, confusion, problems with speech, prolonged headache;
  • signs of bleeding in your digestive tract --severe stomach pain, pink or brown urine, black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds;
  • signs of tumor cell breakdown --lower back pain, blood in your urine; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse; or
  • kidney problems --little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • pale skin, easy bruising or bleeding;
  • fever, chills, flu symptoms;
  • nausea, diarrhea;
  • tired feeling;
  • 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 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.

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