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Side Effects

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Understanding Possible Side Effects of IMBRUVICA® (ibrutinib)

IMBRUVICA® may cause serious side effects, including1:

  • 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
  • Liver problems
  • Tumor lysis syndrome (TLS)*

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

The most common side effects in the WM clinical study during which IMBRUVICA® was administered in combination with rituximab were1:

  • Bruising
  • Muscle, bone, and joint pain
  • Bleeding
  • Diarrhea
  • Joint pain
  • Rash
  • Nausea
  • Hypertension

In the WM clinical study for IMBRUVICA® administered in combination with rituximab, 5% of patients stopped taking IMBRUVICA® therapy because of side effects.2

The most common side effects during ibrutinib single agent therapy study in previously treated patients were1:

  • Low white blood cell count
  • Low blood platelet count
  • Diarrhea
  • Bruising
  • Bleeding
  • Low red blood cell count
  • Nausea
  • Rash
  • Muscle, bone, and joint pain

In WM clinical trials with ibrutinib single agent therapy, 6% of patients stopped taking IMBRUVICA® because of side effects.3

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

If you are having some side effects, your doctor may tell you to lower your dose or to stop taking IMBRUVICA®. That’s one reason it’s so important to tell your healthcare team about side effects at any point in your treatment.1

Helpful tips for WM patients taking IMBRUVICA®

You may experience side effects while taking IMBRUVICA®.1 The suggestions below may help you while on IMBRUVICA®. Talk to your healthcare provider if you think you are experiencing any side effects.

To help with diarrhea4:

  • 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 tobacco

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 tiredness5:

  • 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 infection6:

  • 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

References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. 2. Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 trial of ibrutinib plus rituximab in Waldenström’s macroglobulinemia. N Engl J Med. 2018;378(25):2399-2410. 3. Data on file. Pharmacyclics LLC. 4. American Cancer Society. Getting help with diarrhea. Accessed August 19, 2022. https://www.cancer.org/content/dam/cancer-org/cancer-control/en/booklets-flyers/getting-help-for-diarrhea-english.pdf 5. American Cancer Society. Managing fatigue or weakness. Accessed August 18, 2022. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-cancer-related-fatigue.html  6. American Cancer Society. Preventing infections in people with cancer. Accessed August 19, 2022. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/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.

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*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.