Uses of Ibrutinib Tablets:

• It is used to treat types of leukemia and lymphoma.
• It is used to treat Waldenstroms' macroglobulinemia (WM).
• It is used to treat graft versus host effects after a bone marrow transplant.
• 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 Tablets?

• If you are allergic to this medicine (ibrutinib tablets); any part of this medicine (ibrutinib tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine (ibrutinib tablets), like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this medicine (ibrutinib tablets).
• If you are pregnant or may be pregnant. Women must use birth control while taking this medicine (ibrutinib tablets) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

This is not a list of all drugs or health problems that interact with this medicine (ibrutinib tablets).

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 (ibrutinib tablets) 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 Tablets?

• Tell all of your health care providers that you take this medicine (ibrutinib tablets). 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 (ibrutinib tablets) is stopped, your doctor will tell you when to start taking this medicine (ibrutinib tablets) again after your surgery or procedure.
• Constipation, diarrhea, throwing up, and upset stomach are common with this medicine (ibrutinib tablets). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.
• 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. Rarely, some bleeding problems have been deadly.
• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• Patients with cancer who take this medicine (ibrutinib tablets) may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS).This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine (ibrutinib tablets). 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.
• Very bad and sometimes deadly kidney problems have happened with this medicine (ibrutinib tablets). 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.
• Liver problems have rarely happened with this medicine (ibrutinib tablets). Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• If you are 65 or older, use this medicine (ibrutinib tablets) with care. You could have more side effects.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start this medicine (ibrutinib tablets) to show that you are NOT pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Men with a partner who may get pregnant must use birth control while taking this medicine (ibrutinib tablets) and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is this medicine (Ibrutinib Tablets) best taken?

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

• Swallow whole. Do not chew, break, or crush.
• Take this medicine (ibrutinib tablets) at the same time of day.
• Take with a full glass of water.
• Keep taking this medicine (ibrutinib tablets) 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 this medicine (ibrutinib tablets). Have your blood pressure checked as you have been told by your doctor.
• If diarrhea or throwing up happens, talk with the doctor. You will need to make sure to avoid dehydration and electrolyte problems.
• 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.

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.

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, swallowing, 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 skin infection like oozing, heat, swelling, redness, or pain.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• 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.
• Change in eyesight.
• Change in color or size of a mole.
• A skin lump or growth.
• Abnormal heartbeats have happened with this medicine (ibrutinib tablets). Sometimes, this has been deadly. Call your doctor right away if you have a fast or abnormal heartbeat, chest pain, dizziness, or if you feel like passing out.

What are some other side effects of Ibrutinib Tablets?

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 dizzy, tired, or weak.
• Muscle or joint pain.
• Muscle spasm.
• Anxiety.
• Signs of a common cold.
• Dry eyes.
• More tears.
• Trouble sleeping.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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 Tablets?

• Store in the original container at room temperature.
• Keep lid tightly closed.
• 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.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (ibrutinib tablets), 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.

Frequently asked questions

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