Side EffectsSide Effects

Starting and
Taking IMBRUVICA® (ibrutinib)

Important Things to Know When Starting Treatment1

Your doctor is your trusted partner in your healthcare journey with chronic graft versus host disease (cGVHD). Please follow their guidance about starting and taking IMBRUVICA®. Once you start, it is important to take IMBRUVICA® every day as directed by your doctor to get the full benefit of your treatment.

Dosing that fits into your life1

IMBRUVICA® is an oral, once-a-day treatment for adults with cGVHD that gives you the freedom to take with a glass of water, with or without meals, on a schedule that meets your needs. IMBRUVICA® provides the ease of oral dosing—so you can focus more on what really matters.

Previously treated cGVHD: Adults

IMBRUVICA® is dosed once a day as either a single 420-mg tablet or three 140-mg capsules.

IMBRUVICA® tablets come in a blister pack

Take one 420-mg IMBRUVICA® tablet by mouth at about the same time each day with a glass of water.

Learn more about the IMBRUVICA® tablets blister pack

  • It contains 28 tablets (a 4-week supply)
  • Each tablet is identical
  • Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions

OR

IMBRUVICA® capsules come in a bottle

Take all three 140-mg IMBRUVICA® capsules by mouth at about the same time each day with a glass of water.

Learn more about the IMBRUVICA® capsules bottle

  • The bottle contains a 30-day supply based on recommended dosing
  • Each capsule is identical

Tablets and capsules are not shown at actual size. Talk to your doctor about which dosing option is right for you.


Previously treated cGVHD: Children (1 year and older)

For patients 12 years of age or older, IMBRUVICA® is dosed once a day as either a single 420-mg tablet or three 140-mg capsules.

For patients 1 to less than 12 years of age, talk to your doctor about dose options and the correct dose amount (based on the child's weight and height).

IMBRUVICA® oral suspension comes in a bottle

Helpful resources for preparing and dosing liquid IMBRUVICA®

Learn more about IMBRUVICA® Oral Suspension

  • Glass bottle with child-resistant screw cap
  • 2 reusable/washable oral dosing syringes
  • Dose amount is dependent on the child’s weight, height, and age

IMBRUVICA® tablets come in a blister pack

Take one 420-mg IMBRUVICA® tablet by mouth at about the same time each day with a glass of water.

Learn more about the IMBRUVICA® tablets blister pack

  • It contains 28 tablets (a 4-week supply)
  • Each tablet is identical
  • Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions

OR

IMBRUVICA® capsules come in a bottle

Take all three 140-mg IMBRUVICA® capsules by mouth at about the same time each day with a glass of water.

Learn more about the IMBRUVICA® capsules bottle

  • The bottle contains a 30-day supply based on recommended dosing
  • Each capsule is identical

Tablets and capsules are not shown at actual size. Talk to your doctor about which dosing option is right for you.

Dosing considerations1

Take 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 you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take 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.

What should I avoid while taking IMBRUVICA®?

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.

What you should know about the side effects of IMBRUVICA®1

Before taking any medicine, it’s important to understand its benefits and risks. Your doctor can help you understand what to expect before starting treatment with IMBRUVICA® and can address side effects if you experience them.

Your doctor may consider a dose adjustment to manage certain side effects, including pausing or stopping IMBRUVICA®.

Take IMBRUVICA® exactly as your doctor instructs.

IMBRUVICA® may cause serious side effects, including:

  • Bleeding problems (hemorrhage)
  • Infections
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter)
  • Heart failure and death
  • High blood pressure (hypertension)
  • Decrease in blood cell counts
  • Second primary cancers
  • Tumor lysis syndrome (TLS)*

*TLS is a disorder caused by the fast breakdown of cancer cells, which can lead to kidney failure and other abnormalities.

The most common side effects of IMBRUVICA® in adults or children 1 year of age and older with cGVHD include1:

  • Tiredness
  • Muscle spasms
  • Low red blood cell count (anemia)
  • Mouth sores (stomatitis)
  • Bruising
  • Bleeding
  • Diarrhea
  • Nausea
  • Low platelet count
  • Stomach pain
  • Muscle and joint pain
  • Pneumonia
  • Fever
  • Headache

In the adult and pediatric cGVHD clinical trials, nearly 1 in 4 of patients stopped taking IMBRUVICA® because of side effects.1

This is not a complete list of side effects. Others may occur. Tell your doctor if you think you are experiencing side effects.

Helpful tips for cGVHD patients taking IMBRUVICA®

The suggestions below may help with your IMBRUVICA® treatment.

To help with diarrhea2:

  • Stay hydrated. Drink fluids such as water, decaffeinated tea, and clear broth
  • Eat small meals often, and avoid very hot or spicy foods
  • Avoid greasy foods, bran, raw fruits and vegetables, and caffeine
  • Avoid alcohol and drinks with caffeine

Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

To help reduce tiredness3:

  • Balance periods of light movement with periods of rest
  • Get plenty of sleep, which may include short naps
  • Remain well hydrated throughout the day
  • Eat a well-balanced diet

To help prevent infection4:

  • Wash hands often and bathe every day
  • Avoid crowds and individuals with contagious diseases
  • Do not keep fresh flowers or live plants in your living space
  • Do not clean up droppings from your pets; have someone else do this for you

Infection is a serious possible side effect of IMBRUVICA®. Notify a healthcare professional immediately if signs of infection (eg, fever, chills, weakness, and confusion) occur.1

Storing IMBRUVICA®

See information about storing IMBRUVICA® here.

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2American Cancer Society. Getting help for diarrhea. Revised April 2020. Accessed May 9, 2023. https://www.cancer.org/content/dam/cancer-org/cancer-control/en/booklets-flyers/getting-help-for-diarrhea.pdf 3American Cancer Society. Managing fatigue or weakness. Revised February 1, 2020. Accessed May 9, 2023. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-cancer-related-fatigue.html. 4American Cancer Society. Watching for and Preventing Infections. Accessed May 9, 2023. https://www.cancer.org/cancer/managing-cancer/side-effects/low-blood-counts/infections/preventing-infections-in-people-with-cancer.html

From the moment you’re prescribed IMBRUVICA®, IMBRUVICA® By Your Side provides resources and support for getting the help you may need during treatment.*

Coverage and Cost

Confirm your coverage and out-of-pocket costs for IMBRUVICA®.

Support Communications

Receive periodic emails with tips and information about treatment.

IMBRUVICA® By Your Side Ambassadors

Call a By Your Side Ambassador if you have questions about IMBRUVICA®.

IMBRUVICA® By Your Side patient support program is not intended to provide medical advice, replace prescribed treatment plans, or provide treatment or case management services. Patients are advised to talk to their healthcare provider and treatment team about any medical decisions and concerns they may have. By Your Side Ambassadors are provided by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie Company, and do not work under the direction of your healthcare professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.

Pharmacyclics, an AbbVie Company, may collect your personal data through your online and offline interactions with us, including your contact, demographic, geolocation, and health-related data. We may also collect your online usage data automatically through cookies and similar technologies. We use this data for several purposes, such as to provide you with and improve our programs, services, and products, customize your experiences, and for research and analytics. We retain your personal data for as long as necessary to fulfill these purposes or to comply with our record retention obligations. We do not sell your personal data but may use and disclose your personal data with marketing and advertising partners to deliver you ads based on your interests inferred from your activity across other unaffiliated sites and services (“online targeted advertising”) and for website analytics. To opt out of the use or disclosure of your personal data for online targeted advertising or for website analytics, go to Your Privacy Choices on our website. For more information on the personal data categories we collect, the purposes for their collection, our disclosures to third parties, your data subject rights, and our data retention criteria, visit our Privacy Notice.

Through my submission of the program enrollment form, I consent to the collection, use, and disclosure of my personal health data, as described in the Privacy Notice above and in AbbVie’s Privacy Notice in the How We May Disclose Personal Data section. My consent is required to process sensitive personal data under certain privacy laws, and I have the right to withdraw my consent by visiting Your Privacy Choices on AbbVie’s website.

IMBRUVICA® (ibrutinib) is covered by U.S. Patents, which are listed in FDA's Orange Book (available at
https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm).