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Imbruvica

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

Medically reviewed on Nov 6, 2018

What is Imbruvica?

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

Imbruvica is used to treat mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma. This medicine is also used to treat chronic graft-versus-host disease.

Imbruvica is usually given after other treatments have have not been effective.

Imbruvica 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.

Important Information

Imbruvica 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.

Before taking this medicine

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

Using Imbruvica 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 Imbruvica. 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 Imbruvica?

Take Imbruvica exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Imbruvica is usually taken until your body no longer responds to the medication.

Take this medicine with a full glass of water, at the same time each day. Drink plenty of liquids while you are taking this medicine.

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

Do not open, break, or chew the Imbruvica capsules. Do not cut, crush, or chew the tablets. Swallow both tablets and capsules whole.

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 Imbruvica.

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.

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

Imbruvica dosing information

Usual Adult Dose for Lymphoma:

Mantle Cell Lymphoma (MCL) OR Marginal Zone Lymphoma (MZL): 560 mg orally once a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Uses:
-Treatment of MCL patients who have received at least one prior therapy
-Treatment of MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL):
-Monotherapy: 420 mg orally once a day
-In Combination with Bendamustine and Rituximab: 420 mg orally once a day every 28 days for up to 6 cycles

Duration of Therapy: Until disease progression or unacceptable toxicity

Use: Treatment of CLL/SLL patients with or without 17p deletion

Usual Adult Dose for non-Hodgkin's Lymphoma:

Waldenstrom's Macroglobulinemia (WM) OR Chronic Graft Versus Host Disease (cGVHD): 420 mg orally once a day

Duration of Therapy:
-WM: Until disease progression or unacceptable toxicity
-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity.

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 Imbruvica?

Grapefruit and Seville oranges may interact with ibrutinib and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

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 this medicine and call your doctor at once if you have:

  • signs of infection - fever, chills, weakness, mouth sores, cough with mucus, trouble breathing;

  • 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;

  • severe or ongoing diarrhea;

  • chest pain, pounding heartbeats or fluttering in your chest, feeling like you might pass out;

  • easy bruising, unusual bleeding, purple or red spots under your skin;

  • pale skin, cold hands and feet;

  • kidney problems - little or no urinating, swelling in your feet or ankles; or

  • 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.

Common Imbruvica 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 Imbruvica?

Other drugs may interact with 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.

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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