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Ibrutinib

(eye-broo-tuh-nib)

Trade/other name(s): Imbruvica

Why would this drug be used?

This drug is used to treat chronic lymphocytic leukemia (CLL) and a type of non-Hodgkin lymphoma known as mantle cell lymphoma (MCL). It is also being studied for use against other types of leukemia, lymphoma, and other cancers.

How does this drug work?

Ibrutinib is a type of targeted therapy called a tyrosine kinase inhibitor. Tyrosine kinases are proteins on or near the surface of a cell that send signals to the cell’s control center. Some of these signals help cancer cells to grow and survive. Ibrutinib blocks these signals, which helps stop cancer cells from growing.

Before taking this medicine

Tell your doctor…

  • If you are allergic to any medicines, dyes, additives, or foods.
  • If you have any bleeding problems or take medicines because of a history of having blood clots. This drug might make bleeding worse, which in some cases could be life threatening (see “Precautions”).
  • If you are planning to have surgery or any medical or dental procedures soon. Because this drug can increase the risk of bleeding, you might need to stop (or delay starting) this drug before any procedures.
  • If you have any type of liver disease (including hepatitis). This drug is cleared from the body mainly by the liver. If your liver isn’t working well, too much of this drug might stay in your body, which could lead to serious side effects.
  • If you have any type of kidney disease. This drug can damage the kidneys. Your doctor might need to watch you more closely during treatment (see “Precautions”).
  • If you have any other medical conditions such as heart disease, congestive heart failure, gout, diabetes, or infections. These conditions may require more careful monitoring by your doctor.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug can cause problems with the fetus if taken during pregnancy (see “Precautions”).
  • If you are breastfeeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Breastfeeding is not recommended during treatment with this drug.
  • If you think you might want to have children in the future. It’s not known if this drug affects fertility. Talk with your doctor about the possible risk with this drug.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Ibrutinib can interact with a number of drugs and supplements, so it is important to tell your health care team about all of your medicines (including vitamins and other supplements), and to check with them before starting or stopping any medicines.

Some drugs and supplements could cause ibrutinib levels to build up in your blood. This could worsen side effects and other problems. If you take any of these drugs, your doctor might need to switch you to a different drug. If you can’t be switched to a different drug, your doctor will need to watch you closely and might need to adjust your dose of ibrutinib.

  • Some antibiotics, such as erythromycin, clarithromycin (Biaxin), telithromycin (Ketek), and similar drugs
  • Anti-fungal medicines such as ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole (Vfend), and posaconazole (Noxafil)
  • Some anti-depressant drugs, such as nefazodone (Serzone)
  • Anti-HIV drugs such as indinavir (Crixivan), ritonavir (Kaletra), nelfinavir (Viracept), atazanavir (Reyataz), saquinavir (Invirase), and others
  • Drugs used to treat hepatitis C virus (HCV) infection, such as boceprevir (Victrelis) and telaprevir (Incivek)

Some drugs and supplements can lower the levels of ibrutinib in the blood, which might make it less effective. These drugs should be avoided unless the benefit of taking them outweighs the risk of having lower blood levels of ibrutinib.

  • Anti-seizure drugs, such as carbamazepine (Tegretol), phenobarbital (Solfoton), and phenytoin (Dilantin)
  • Drugs to treat tuberculosis (TB), such as rifampin (Rifadin, Rimactane; also in Rifamate and Rifater), rifabutin (Mycobutin), and rifapentine (Prifin)
  • The steroid drug dexamethasone (Decadron)
  • St. John’s wort (herbal dietary supplement)

Drugs or supplements that interfere with blood clotting might raise your risk of bleeding during treatment with ibrutinib. These include:

  • Vitamin E
  • Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • Warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), or other blood thinners, including any type of heparin injections
  • Clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your doctor or pharmacist before taking any of these medicines.

Other medicines or supplements may affect blood levels of ibrutinib, or levels of these drugs may be affected by taking ibrutinib. Make sure your doctor knows about all of the drugs and supplements you are taking.

Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

Grapefruit, grapefruit juice, grapefruit extract, and Seville oranges (often used in marmalades) can affect the amount of ibrutinib in your body. You should avoid these products while taking this drug. Check with your doctor, nurse, or pharmacist about whether any other specific foods could be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Ibrutinib is taken by mouth as 140 milligram (mg) capsules. The usual starting dose is 420 mg (3 capsules) for CLL or 560 mg (4 capsules) for MCL, taken once a day at about the same time each day. The dose may be lower if you are taking certain other drugs. The dose may need to be delayed and/or adjusted if you have certain side effects during treatment.

Swallow the capsules whole, with a glass of water. Do not open, break, or chew the capsules. Avoid grapefruit products and Seville oranges while taking this drug.

Take this drug exactly as directed by your doctor. If you do not understand the instructions, ask your doctor or nurse to explain them to you. Store the medicine in a tightly closed container away from heat and moisture and away from children and pets.

Precautions

This drug can interact with a number of other drugs or supplements in the body – see “Interactions” above. Be sure your doctor is aware of all drugs and supplements you are taking. Do not start or stop taking any drug without talking to your doctor about all the drugs you are taking.

This drug can increase your risk of bleeding, which in some cases can be serious or even life threatening. Speak with your doctor before taking any drugs or supplements that might affect your body’s ability to stop bleeding, such as aspirin or aspirin-containing medicines, blood thinners like warfarin (Coumadin), or vitamin E (see “Interactions” above). You might need to stop taking this drug before any surgical, medical, or dental procedures and for several days afterward. Tell your doctor right away if you cough up or vomit blood or have unusual bruising or bleeding, such as nosebleeds, heavy menstrual bleeding, bleeding gums when you brush your teeth, pink or brown urine, or black, tarry stools. Also tell your doctor if you have symptoms that might be due to bleeding in the brain, such as feeling dizzy or weak, confusion, change in your speech, or a headache that lasts a long time.

This drug can cause kidney damage, which in some cases could be serious or even fatal. Your doctor will test your blood for signs of kidney damage before and during treatment and may need to reduce or delay your next dose of this drug, or even stop it altogether. Be sure to drink plenty of fluids while taking this drug, which can help protect your kidneys. Tell your doctor or nurse if you have symptoms that might be related to kidney damage, such as changes in urination or swelling in your hands, legs, or feet.

Your doctor will test your blood before and during your treatment to check for the effects of the drug on blood cell counts. Based on the test results, your doctor may need to reduce or delay your next dose of this drug, or even stop it altogether. Keep all your appointments for doctor visits and lab tests.

This drug can lower your white blood cell count. This can increase your chance of getting a serious infection, which in some cases might even be life threatening. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), chills, pain when passing urine, a new cough, or bringing up sputum.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor’s OK. This drug might affect your immune system, which could make vaccinations ineffective, or could even lead to serious infections. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

This drug might increase your risk of developing another cancer, especially skin cancer, later on.

This drug should not be taken if you are pregnant or breastfeeding. Ibrutinib can cause problems with the fetus if taken during pregnancy. Women should avoid becoming pregnant while taking this drug. Check with your doctor about what kinds of birth control can be used with this medicine. This drug might also pass into breast milk, which could affect the baby.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Diarrhea
  • Feeling tired
  • Muscle or bone pain
  • Swelling in the hands, legs, or feet
  • Upper respiratory infection (such as a cold or flu)
  • Nausea or vomiting
  • Bruising
  • Shortness of breath
  • Skin rash
  • Constipation
  • Abdominal (belly) pain
  • Loss of appetite
  • Abnormal blood tests suggesting drug is affecting the kidneys (your doctor will discuss the importance of these findings, if any)*
  • Low blood platelet count, which can increase the risk of bleeding*
  • Low counts of certain white blood cells (neutropenia), which can increase the risk of serious infection*
  • High counts of white blood cells called lymphocytes (lymphocytosis), which rarely can lead to symptoms such as headache or feeling sluggish or unsteady
  • Low red blood cell count (anemia)

Less common

  • Cough
  • Fever
  • Mouth sores
  • Urinary tract infection
  • Pneumonia
  • Skin infection
  • Feeling weak
  • Feeling dizzy
  • Muscle spasms
  • Headache
  • Sinus infection
  • Upset stomach
  • Dehydration
  • Joint pain
  • Nosebleeds
  • A type of irregular heartbeat called atrial fibrillation
  • Serious bleeding in the brain, digestive tract, or elsewhere*
  • Development of another cancer*

Rare

  • Death due to kidney failure*, serious infection*, or other causes

*See “Precautions” section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2013

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 11/19/2013
Last Revised: 02/12/2014