Ibrutinib
Brand Name(s):
  • Imbruvica®
WHY is this medicine prescribed?
Ibrutinib is used to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) or with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) who have already been treated with at least one other chemotherapy medication. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

HOW should this medicine be used?
Ibrutinib comes as a capsule to take by mouth. Take ibrutinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ibrutinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a full glass of water; do not open, break, or chew them.

Your doctor may decrease your dose of ibrutinib during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take ibrutinib even if you feel well. Do not stop taking ibrutinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?
Before taking ibrutinib,

  • tell your doctor and pharmacist if you are allergic to ibrutinib or any other medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin, Prevpac), erythromycin (E.E.S., E-Mycin, Erythrocin), and telithromycin (Ketek); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as fluconazole (Diflucan); itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); antiplatelet medications such as clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), and ticlopidine (Ticlid); aprepitant (Emend); crizotinib (Xalkori); digoxin (Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac, others); imatinib (Gleevec); certain medications to treat hepatitis C such as boceprevir (Victrelis) and telaprevir (Incivek); certain medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); nefazodone; certain medications to treat seizures such as carbamazepine (Carbatrol, Tegretol) and phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rifamate, Rimactane, others); or verapamil (Calan, Covera, Isoptin, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's Wort.
  • tell your doctor if you recently had surgery. Also tell your doctor if you have or have ever had bleeding problems, or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant during your treatment with ibrutinib. If you become pregnant while taking ibrutinib, call your doctor immediately. Ibrutinib can cause fetal harm.
  • tell your doctor if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ibrutinib.
What SPECIAL DIETARY instructions should I follow?
Do not eat grapefruit or Seville oranges (sometimes used in marmalades), or drink grapefruit juice while taking this medication.

Make sure you drink plenty of water or other fluids every day while you are taking ibrutinib.

What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it that day. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?
Ibrutinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • diarrhea
  • nausea
  • constipation
  • vomiting
  • stomach pain
  • heartburn or indigestion
  • decreased appetite
  • excessive tiredness or weakness
  • muscle and joint pain
  • muscle spasms
  • swelling of the hands, feet, ankles, or lower legs
  • shortness of breath
  • rash
  • dizziness
  • headache
  • sores in the mouth and throat
  • fast heart beat

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
  • unusual bruising or bleeding
  • pink, red, or dark brown urine
  • bloody or black, tarry stools
  • bloody vomit; or vomiting blood or brown material that resembles coffee grounds
  • fever, chills, cough, or other signs of infection
  • confusion
  • changes in your speech
  • decreased urination
  • anxiety
  • difficulty falling asleep or staying asleep

Ibrutinib may increase your risk of developing certain types of cancer including cancer of the skin or other organs. Talk to your doctor about the risks of taking ibrutinib.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture not in the bathroom. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ibrutinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2014.







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