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Ibrutinib

Generic Name: Ibrutinib (eye BROO ti nib)
Brand Name: Imbruvica

Uses of Ibrutinib:

  • It is used to treat a type of lymphoma.
  • It is used to treat a type of leukemia.
  • It is used to treat Waldenstroms' macroglobulinemia (WM).
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Ibrutinib?

  • If you have an allergy to ibrutinib or any other part of ibrutinib.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with ibrutinib.
  • If you are taking St. John's wort. Do not take St. John's wort with this medicine. This medicine may not work as well.

This is not a list of all drugs or health problems that interact with ibrutinib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ibrutinib?

  • Tell all of your health care providers that you take ibrutinib. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If this medicine is stopped, your doctor will tell you when to start taking ibrutinib again after your surgery or procedure.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Very bad and sometimes deadly bleeding problems have happened with ibrutinib. Talk with the doctor.
  • This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
  • Patients with cancer who take this medicine may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
  • A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with ibrutinib. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting ibrutinib. Talk with your doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 1 month after care ends. Use birth control that you can trust.
  • If you are a man and your sex partner gets pregnant while you take this medicine or within 1 month after your last dose, call your doctor right away.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust to prevent pregnancy while taking ibrutinib and for 1 month after stopping this medicine.
  • If you get pregnant while taking ibrutinib or within 1 month after your last dose, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Ibrutinib) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take ibrutinib at the same time of day.
  • Take with a full glass of water.
  • Swallow whole. Do not chew, break, or crush.
  • Do not open the capsules.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Avoid grapefruit and grapefruit juice.
  • Avoid Seville oranges.
  • High blood pressure has happened with ibrutinib. Have your blood pressure checked as you have been told by your doctor.
  • If loose stools (diarrhea) or throwing up happens, you will need to make sure to avoid dehydration and electrolyte problems. Talk with the doctor.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it on the same day you missed the dose.
  • If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • A burning, numbness, or tingling feeling that is not normal.
  • Dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very loose stools (diarrhea).
  • Feeling very tired or weak.
  • Dry mouth.
  • Dry skin.
  • Change in color or size of a mole.
  • A skin lump or growth.
  • Very bad and sometimes deadly kidney problems have happened with this medicine. Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.

What are some other side effects of Ibrutinib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Not hungry.
  • Upset stomach or throwing up.
  • Belly pain.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Muscle or joint pain.
  • Muscle spasm.
  • Anxiety.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ibrutinib?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ibrutinib, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 ibrutinib. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ibrutinib.

Review Date: September 6, 2017

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