Imbruvica

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

Imbruvica is used for:

Treating mantle cell lymphoma (MCL). It is also used to treat chronic lymphocytic leukemia (CLL).

Imbruvica is a tyrosine kinase inhibitor. It works by helping to stop cancer cells from growing.

Do NOT use Imbruvica if:

  • you are allergic to any ingredient in Imbruvica
  • you are taking boceprevir, carbamazepine, indinavir, nefazodone, nelfinavir, phenytoin, rifampin, ritonavir, saquinavir, St. John's wort, or telaprevir

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Imbruvica:

Some medical conditions may interact with Imbruvica. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, kidney problems, high blood pressure, high cholesterol, diabetes, heart problems (eg, irregular heartbeat), blood problems, or bleeding problems
  • if you have an infection
  • if you smoke or have smoked in the past
  • if you have had recent surgery or plan to have surgery

Some MEDICINES MAY INTERACT with Imbruvica. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aprepitant, azole antifungals (eg, fluconazole), ciprofloxacin, crizotinib, diltiazem, imatinib, macrolide antibiotics (eg, erythromycin), nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, troleandomycin, or verapamil because they may increase the risk of Imbruvica's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifabutin, rifampin, rifapentine), or St. John's wort because they may decrease Imbruvica's effectiveness
  • Anticoagulants (eg, warfarin) or antiplatelet medicines (eg, clopidogrel) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Imbruvica may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Imbruvica:

Use Imbruvica as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Imbruvica by mouth with a glass of water.
  • Take with or without food.
  • Swallow Imbruvica whole. Do not open, break, or chew before swallowing.
  • Avoid food or drink containing grapefruit or Seville oranges while you are taking Imbruvica.
  • Drinking extra fluids while you are taking Imbruvica is recommended. Check with your doctor for instructions.
  • Take Imbruvica on a regular schedule to get the most benefit from it. Taking Imbruvica at the same time each day will help you to remember to take it.
  • If you miss a dose of Imbruvica, take it as soon as possible on the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.

Ask your health care provider any questions you may have about how to use Imbruvica.

Important safety information:

  • Imbruvica may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection such as fever, sore throat, rash, or chills.
  • Severe and sometimes deadly infections have occurred with Imbruvica. Discuss any questions or concerns with your doctor.
  • Imbruvica may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Severe and sometimes deadly kidney problems have occurred with Imbruvica. Discuss any questions or concerns with your doctor.
  • Other types of cancer (eg, skin cancer) have occurred with Imbruvica. Discuss any questions or concerns with your doctor.
  • If you have nausea, vomiting, diarrhea, or loss of appetite, talk with your doctor. There may be ways to lower these side effects.
  • Tell your doctor or dentist that you take Imbruvica before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests may be performed while you use Imbruvica. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Imbruvica with caution in the ELDERLY; they may be more sensitive to its effects.
  • Imbruvica should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Imbruvica may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Imbruvica is found in breast milk. Do not breast-feed while you are taking Imbruvica.

Possible side effects of Imbruvica:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; headache; joint pain; loss of appetite; muscle or bone pain; muscle spasms; nausea; runny or stuffy nose; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest discomfort; dizziness or light-headedness; dry eyes, mouth, or skin; fainting; irregular heartbeat; mouth sores or ulcers; severe or persistent diarrhea, nausea, loss of appetite, stomach pain, or vomiting; severe or persistent headache; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of bleeding (eg, bloody, black, or tarry stools; nosebleeds; pink or brown urine; any bleeding that is very bad or that you cannot stop; vomiting blood or vomit that looks like coffee grounds; coughing up blood; bruises without a reason or that get bigger; dizziness; confusion; speech changes; severe or persistent headache); symptoms of infection (eg, fever, chills, persistent sore throat or cough, difficult or painful urination; warm, red, swollen, or painful skin); symptoms of kidney problems (eg, blood in the urine; change in the amount of urine produced); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Imbruvica:

Store Imbruvica at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store in the original package. Keep Imbruvica out of the reach of children and away from pets.

General information:

  • If you have any questions about Imbruvica, please talk with your doctor, pharmacist, or other health care provider.
  • Imbruvica is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Imbruvica or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Imbruvica. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Imbruvica. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Imbruvica.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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