Pronunciation:

eye-BROO-ti-nib

Brand Names:

• Imbruvica

Dosage Forms:

• Capsule
• Tablet
• Suspension

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Ibrutinib is used to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) in patients with 17p deletion, and Waldenström macroglobulinemia (WM). It is also used to treat chronic graft-versus-host disease (cGHVD) after one or more lines of treatment did not work. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Ibrutinib is an antineoplastic agent (cancer medicine).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ibrutinib to treat chronic graft-versus-host disease (cGHVD) in children younger than 1 year of age and to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) with 17p deletion, and Waldenström macroglobulinemia (WM) in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibrutinib in the elderly. However, elderly patients are more likely to have unwanted effects (eg, anemia, pneumonia, bleeding problems, high blood pressure, heart rhythm problems), which may require caution in patients receiving ibrutinib.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Adagrasib
• Anagrelide
• Apixaban
• Aprepitant
• Ardeparin
• Argatroban
• Aspirin
• Atazanavir
• Belzutifan
• Bemiparin
• Bivalirudin
• Boceprevir
• Carbamazepine
• Certoparin
• Cilostazol
• Ciprofloxacin
• Clarithromycin
• Clopidogrel
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Dalteparin
• Danaparoid
• Desirudin
• Diltiazem
• Dipyridamole
• Dronedarone
• Drotrecogin Alfa
• Duvelisib
• Edoxaban
• Enoxaparin
• Enzalutamide
• Eptifibatide
• Erythromycin
• Fedratinib
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fondaparinux
• Fosnetupitant
• Fosphenytoin
• Heparin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivosidenib
• Ketoconazole
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lepirudin
• Letermovir
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotane
• Nadroparin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nirmatrelvir
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Parnaparin
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Pirtobrutinib
• Posaconazole
• Prasugrel
• Primidone
• Protein C
• Reviparin
• Rifampin
• Ritlecitinib
• Ritonavir
• Rivaroxaban
• Saquinavir
• St John's Wort
• Sulfinpyrazone
• Telaprevir
• Telithromycin
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tocilizumab
• Treprostinil
• Trofinetide
• Verapamil
• Vorapaxar
• Voriconazole
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Bitter Orange
• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Atrial fibrillation (heart rhythm problem), history of or
• Bleeding problems or
• Diabetes or
• Hypertension (high blood pressure) or
• Stroke, history of—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine at the same time each day.

Swallow the capsule or tablet whole with a glass of water. Do not open, crush, break, or chew it.

Measure the oral liquid medicine with the provided oral dosing syringe.

Drink plenty of water each day to help prevent dehydration caused by diarrhea.

Do not drink grapefruit juice or eat grapefruit or Seville oranges with this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules, tablets, or suspension):
  • For chronic graft versus host disease:
    • Adults and children 12 years of age and older—420 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children 1 to younger than 12 years of age—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 240 milligrams per square meter (mg/m[2]) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
  • For chronic lymphocytic leukemia or small lymphocytic lymphoma alone or together with bendamustine and rituximab or obinutuzumab, or Waldenström macroglobulinemia alone or together with rituximab:
    • Adults—420 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Take the missed dose only if it is the same day as the scheduled dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid 60 days after opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Women should use an effective form of birth control during treatment and for 1 month after the last dose. Men should use an effective form of birth control during treatment and for 1 month after the last dose to prevent pregnancy in a sexual partner. If you think a pregnancy has occurred with this medicine, tell your doctor right away.

This medicine may cause bleeding problems. Check with your doctor right away if you have bloody or black, tarry stools, red or dark brown urine, severe stomach pain, unusual bleeding, bruising, or weakness, or vomiting of blood or material that looks like coffee grounds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Call your doctor right away if you have a cough that would not go away, back pain, dizziness or drowsiness, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill.

Ibrutinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain. These may be symptoms of a serious heart problem (eg, heart rhythm problems, heart failure).

This medicine may cause a heart condition called atrial flutter or atrial fibrillation. Check with your doctor right away if you have a fast or irregular heartbeat, trouble breathing, lightheadedness, dizziness, or fainting.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

Using this medicine may increase your risk of getting new cancers, including skin cancer. Talk to your doctor if you have concerns about this risk.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a change in how much or how often you urinate, joint pain, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Back pain

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or black, tarry stools

bloody or cloudy urine

blurred vision

body aches or pain

chest pain or tightness

chills

confusion

cough

decreased frequency or amount of urine

difficult, burning, or painful urination

dizziness or lightheadedness

drowsiness

dry mouth

fainting

fast or irregular heartbeat

fever

frequent urge to urinate

headache

hoarseness

increased thirst

irregular heartbeat

itching

loss of appetite

lower back or side pain

nausea

rapid weight gain

seizures

severe headache

severe stomach pain

sore throat

tingling of the hands or feet

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

vomiting of blood or material that looks like coffee grounds

wrinkled skin

Less common

Persistent non-healing sore

pink skin growth

reddish skin patch or irritated area

shiny skin bump

white, yellow or waxy scar-like area on the skin

Incidence not known

Blistering, peeling, or loosening of the skin

dark urine

diarrhea

dilated neck veins

difficulty swallowing

general feeling of tiredness or weakness

hives, skin rash

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

muscle pain

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Belching

decreased appetite

difficulty having a bowel movement

heartburn or indigestion

indigestion

lack or loss of strength

muscle stiffness or spasms

small red or purple spots on the skin

stomach discomfort, upset, or pain

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.