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

What is Imbruvica?

Imbruvica (ibrutinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Imbruvica is used to treat chronic lymphocytic leukemia (CLL); and mantle cell lymphoma (MCL) in people who have already received at least one other cancer medicine without successful treatment.

Imbruvica is also used to treat CLL in people with 17p deletion or Waldenstrom's macroglobulinemia, even if they have never received prior treatment.

Imbruvica 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.

Imbruvica is also used to treat Waldenström Macroglobulinemia, a rare type of non-Hodgkin lymphoma.

Important information

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.

Before taking this medicine

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

To make sure Imbruvica 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 Imbruvica 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 Imbruvica if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Imbruvica?

Take Imbruvica exactly as your health care provider tells you. 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 Imbruvica.

Imbruvica is usually taken once per day. Take the medicine at the same time each day.

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

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using Imbruvica. 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.

Imbruvica dosing information

Usual Adult Dose for Lymphoma:

560 mg (four 140 mg capsules) 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 (three 140 mg capsules) orally once a day

Use: The treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or CLL with 17p deletion.

See also: Dosage Information (in more detail)

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 Imbruvica?

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

Imbruvica side effects

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

Stop using Imbruvica 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 Imbruvica side effects may include:

  • pale skin, easy bruising or bleeding, fever, chills, flu symptoms;

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

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

  • feeling short of breath;

  • tired feeling;

  • swelling in your legs or feet;

  • 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.

See also: Side effects (in more detail)

What other drugs will affect Imbruvica?

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 Imbruvica.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Imbruvica 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 1996-2016 Cerner Multum, Inc. Version: 2.04. Revision Date: 2015-02-27, 12:59:24 PM.