Side EffectsSide Effects

Starting
and Taking
IMBRUVICA®
(ibrutinib)

HomeWMStarting and Taking IMBRUVICA®

Important Things to Know When Starting Treatment1

Your doctor is your trusted partner in your healthcare journey with Waldenström’s macroglobulinemia (WM). 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 WM 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.

IMBRUVICA® is dosed once a day as a single 420-mg tablet, three 140-mg capsules, or 6 mL of liquid oral suspension (6 mL=420 mg). If your doctor prescribes liquid IMBRUVICA® oral suspension, refer to the detailed Instructions for Use that comes with IMBRUVICA® oral suspension.

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

OR

IMBRUVICA® oral suspension comes in a bottle

Take 6 mL of liquid IMBRUVICA® oral suspension by mouth at about the same time each day. Make sure to drink water after swallowing the dose.

Learn more about the IMBRUVICA® oral suspension bottle

  • Supplied in a glass bottle with child-resistant screw cap

  • The bottle comes with two 3-mL oral syringes

  • Each mL of liquid oral suspension contains 70 mg of IMBRUVICA®

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

Dosing considerations1

  • 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.

IMBRUVICA® comes as capsules, tablets, and oral suspension.

  • 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.

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 could consider a dose adjustment to manage certain side effects so that you may continue to benefit from treatment, including pausing or reducing your dosage. However, in some cases IMBRUVICA® will need to be stopped permanently.

Take or give 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
  • Liver problems
  • 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 in the WM clinical study during which IMBRUVICA® was administered in combination with rituximab were1:

  • Bruising
  • Muscle, bone, and joint pain
  • Bleeding
  • Diarrhea
  • 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 the 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.

Helpful tips for WM patients taking IMBRUVICA®

The suggestions below may help with your IMBRUVICA® treatment.

To help when experiencing 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
  • 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 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

Storing IMBRUVICA®

See information about storing IMBRUVICA® here.

Want to know more about side effects while taking IMBRUVICA®?

Download Here

See the step-by-step Preparing and Dosing Guide for liquid IMBRUVICA®

Download Here

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 for Diarrhea. Accessed March 14, 2024. 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 March 14, 2024. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-cancer-related-fatigue.html 6. American Cancer Society. Watching for and Preventing Infections in people with cancer. Accessed March 14, 2024. 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®.

IMBRUVICA® By Your Side
Registered Nurses

Call the By Your Side Nurse Support Line at 1-888-YourSide (1-888-968-7743) if you have questions about IMBRUVICA®.

Explore Support Options

*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 Registered Nurses 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.