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Generic Name: ibrutinib
Date of Approval: November 13, 2013
Company: Janssen Biotech, Inc.

Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

FDA Approves Imbruvica

The U.S. Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia who have received at least one prior therapy

What is Imbruvica?

Imbruvica is a prescription medicine used to treat people with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia who have received at least one prior treatment.

Slideshow: Flashback: FDA Drug Approvals 2013

It is not known if this medicine is safe and effective in children.

What should I tell my healthcare provider before taking Imbruvica?

Before you take Imbruvica, tell your health care provider about all of your medical conditions, including if you:

  • have had recent surgery or plan to have surgery. Your healthcare provider may stop taking this medicine for any planned medical, surgical, or dental procedure.
  • have bleeding problems
  • have liver problems
  • are pregnant or plan to become pregnant. Imbruvica can harm your unborn baby. You should not become pregnant while taking this medicine.
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take Imbruvica or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Imbruvica with certain other medicines may affect how Imbruvica works and can cause side effects.

How should I take Imbruvica?

  • Take exactly as your health care provider tells you to take it.
  • Take once a day.
  • Swallow capsules whole with a glass of water. Do not open, break, or chew capsules.
  • Take at about the same time each day.
  • If you miss a dose, take it as soon as you remember on the same day. Take your next dose at your regular time on the next day. Do not take two doses on the same day to make up for a missed dose.

What should I avoid?

  • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) while you are taking Imbruvica. These products may increase the amount of the medicine in your blood.

Imbruvica side effects

Imbruvica may cause serious side effects, including:

  • Bleeding problems that can be serious. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that you can not control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, feel dizzy or weak, confusion, change in your speech, or a headache that lasts a long time.
  • Infections. Infections can be serious and may lead to death. Tell your healthcare provider if you have fever, chills, or any other signs or symptoms of an infection while taking this medicine.
  • Decrease in blood cell counts. Your healthcare provider should do monthly blood tests to check your blood counts.
  • Kidney problems. Kidney failure and death have happened with Imbruvica treatment. Drink fluids during treatment to help prevent too much fluid loss (dehydration). Your healthcare provider should do blood tests to check how well your kidneys are working.
  • Second primary cancers. New cancers have happened in people who have been treated with this medicine, including cancers of the skin or other organs.

The most common side effects of Imbruvica include:

  • low blood platelet count, diarrhea, low white blood cell count, low red blood cell count, fatigue, muscle and bone pain, swelling of legs and feet, upper respiratory tract infection, nausea, bruising, shortness of breath, constipation, rash, stomach (abdomen) pain, vomiting, and decreased appetite.

    Diarrhea is a common side effect in people who take this medicine. Tell your healthcare provider if you have diarrhea that does not go away.

    These are not all the possible side effects of Imbruvica. 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)

    How should I store Imbruvica?

    • Store at room temperature between 68°F to 77°F (20°C to 25°C).
    • Keep capsules in the original container with the lid tightly closed.

    Keep Imbruvica and all medicines out of the reach of children.

    General information about the safe and effective use of Imbruvica

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Imbruvica that is written for health professionals.

    What are the ingredients in Imbruvica?

    Active ingredient: ibrutinib

    Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide and black ink.