Medication Guide — Imbruvica

(ibrutinib)

capsules

(ibrutinib)

tablets

(ibrutinib)

oral suspension

IMBRUVICA is a prescription medicine used to treat:

• Adults with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
  
• Adults with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
  
• Adults with Waldenström’s macroglobulinemia (WM).
  
• Adults and children 1 year of age and older with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy.

It is not known if IMBRUVICA is safe and effective in children under 1 year of age.

• have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
  
• have bleeding problems or are taking a blood thinner medicine.
  
• have an infection.
  
• have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
  
• have liver problems.
  
• are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA.
  ○ Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA and for 1 month after the last dose.
  ○ Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA and for 1 month after the last dose.
  
• are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.

including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.

• Take or give IMBRUVICA exactly as your healthcare provider tells you to take or give it.
  
• Take or give IMBRUVICA 1 time a day at about the same time each day.

• If your healthcare provider prescribes IMBRUVICA capsules or tablets:
  ◦ Swallow IMBRUVICA capsules or tablets whole with a glass of water.
  ◦ Do not open, break, or chew IMBRUVICA capsules.
  ◦ Do not cut, crush, or chew IMBRUVICA tablets.
  
• If your healthcare provider prescribes IMBRUVICA oral suspension:
  ◦ See the detailed Instructions for Use that comes with IMBRUVICA oral suspension for information about the correct way to take or give a dose. If you have questions about how to take or give IMBRUVICA oral suspension, talk to your healthcare provider.
  ◦ Do not use if the carton seal is broken or missing.
  
• If you miss a dose of IMBRUVICA, take or give it as soon as you remember on the same day. Take or give the next dose of IMBRUVICA at the regular time on the next day. Do not take or give extra doses of IMBRUVICA to make up for a missed dose.
  
• If you take too much IMBRUVICA, call your healthcare provider, or go to the nearest hospital emergency room right away.

You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA. These products may increase the amount of IMBRUVICA in your blood.

• Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including:

• blood in your stools or black stools (looks like tar)
  
• pink or brown urine
  
• unexpected bleeding, or bleeding that is severe or that you cannot control
  
• vomit blood or vomit looks like coffee grounds
  
• cough up blood or blood clots

• increased bruising, or small red or purple spots on the skin
  
• dizziness
  
• weakness
  
• confusion
  
• change in your speech
  
• headache that lasts a long time or severe headache

• Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA.
  
• Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure and death have happened in people treated with IMBRUVICA, especially in people who have an infection, an increased risk for heart disease, or have had heart rhythm problems in the past. Your heart function will be checked before and during treatment with IMBRUVICA. Tell your healthcare provider if you get any symptoms of heart problems, such as:

• feeling as if your heart is beating fast and irregular
  
• lightheadedness
  
• dizziness

• shortness of breath
  
• swelling of the feet, ankles, or legs

• chest discomfort
  
• feeling faint

If you develop any of these symptoms, your healthcare provider may do tests to check your heart and may change your IMBRUVICA dose.

• High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
  
• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA, but can also be severe.  Your healthcare provider should do monthly blood tests to check your blood counts.
  
• Second primary cancers. New cancers have happened during treatment with IMBRUVICA, including cancers of the skin or other organs.
  
• Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with IMBRUVICA. Your healthcare provider will do blood tests to check your liver before and during treatment with IMBRUVICA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.
  
• Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

• low platelet count

• muscle, bone, and joint pain

• low red blood cell count (anemia)

• diarrhea

• low white blood cell count

• bruising

• tiredness

• rash

• nausea

• tiredness

• muscle, bone, and joint pain

• nausea

• low red blood cell count (anemia)

• fever

• stomach pain

• bruising

• muscle spasms

• pneumonia

• diarrhea

• mouth sores (stomatitis)

• headache

• low platelet count

• bleeding

These are not all the possible side effects of IMBRUVICA.

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

• Store IMBRUVICA capsules and tablets at room temperature between 68°F and 77°F (20°C and 25°C).
  
• Keep IMBRUVICA capsules in the original container with the lid tightly closed.
  
• Keep IMBRUVICA tablets in the original carton.
  
• Store IMBRUVICA oral suspension bottle between 36°F and 77°F (2°C and 25°C). Do not freeze.
  
• Use IMBRUVICA oral suspension within 60 days after first opening the bottle. Throw away (dispose of) any unused portion 60 days after opening.
  
• IMBRUVICA capsules and oral suspension come in a bottle with a child-resistant cap.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals.

ibrutinib

: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The 70 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, and black ink. The 140 mg capsule shell contains gelatin, titanium dioxide, and black ink.

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets).

benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, and sucralose. 

Distributed and Marketed by: Pharmacyclics LLC South San Francisco, CA 94080 USA

Marketed by: Janssen Biotech, Inc. Horsham, PA 19044 USA

© 2025 Pharmacyclics LLC. All rights reserved.

© 2025 Janssen Biotech, Inc. All rights reserved.

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For more information, go to www.imbruvica.com or call 1-877-877-3536.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 10/2025