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IMBRUVICA® (ibrutinib) Dosing for Waldenström’s Macroglobulinemia IMBRUVICA® (ibrutinib) Dosing for Waldenström’s Macroglobulinemia

IMBRUVICA® Dosing for Waldenström's Macroglobulinemia

You can take IMBRUVICA® (ibrutinib) anywhere

Because IMBRUVICA® is an oral medication, you have the freedom to take it at home or wherever you may be. It is important to take your medication at about the same time each day and exactly as directed by your doctor.1

 

How to take IMBRUVICA®1

  • Take all three IMBRUVICA® capsules by mouth, at about the same time each day, with a glass of water

  • Swallow the capsules whole. Do not open, break, or chew

  • Do not stop taking IMBRUVICA® without talking to your doctor

  • Remember to refill your IMBRUVICA® prescription before running out

  • 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 2 doses of IMBRUVICA® on the same day to make up for a missed dose

    • Call your doctor or pharmacist if you have any questions

  • Store IMBRUVICA® in its original container, with the lid tightly closed, at room temperature from 68°F to 77°F (20°C to 25°C)

IMBRUVICA® dosing for Waldenström's Macroglobulinemia
 

While taking IMBRUVICA®1

  • Do not drink grapefruit juice

  • Do not eat grapefruit

  • Do not eat Seville oranges, often used in making marmalade

These foods may increase the amount of IMBRUVICA® in your blood. For more information about drug interactions, please see the Important Product Information. 

Tell your doctor about any other medications you are taking, including prescriptions or over-the-counter medications, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects. 

Dosing Tips


 

Establish a Routine to Remember Your Daily IMBRUVICA® Dose

Keep in mind that your involvement is important to the success of your treatment. It is helpful to develop a routine for taking IMBRUVICA® so you don't risk missing a dose.

  • Routines can help you achieve the goal of taking all doses of your medicine as prescribed, so you get the most benefit

  •  
  • Routines help make actions automatic, so they take less effort2

  •  
  • Routines can help to allow you to focus on other things that are important to you

Strategies to Help You Plan Your IMBRUVICA® Routine

Begin by asking your doctor about specific instructions for when you should take IMBRUVICA®. Plan a time of day that works for you based on these instructions.

 

Link it. Take your medicine at the same time as something else you do on a daily basis, like walking the dog or brushing your teeth.3-5

 

Hear it. Set an alarm on your phone, watch, or clock to go off daily when you need to take IMBRUVICA®, or use the Dose-Alert® included in the starter kit.4-6

 

See it.  Use reminder notes or put your IMBRUVICA® container in a place you will see it (like next to your bed). Keep out of the reach of children.4-6

 

Use your tools. Use the tools, such as the calendar and stickers in your Treatment Journal or the Take and Slide device included in the starter kit, to set reminders for yourself.

Below you will see three tools you can use to remind you to take your IMBRUVICA® medication once a day, at about the same time every day. Remember to always take your medication exactly as your doctor has prescribed. All of these tools are included in the IMBRUVICA® Starter Kit, and it will be mailed to you once you enroll in the YOU&i™ Support Program. Enroll now!

 
Patient adherence for IMBRUVICA®
 

Take and Slide

The Take and Slide allows you to simply slide one tab from the left to the right when you take your medicine each day throughout the week to help you keep track of when you’ve taken it.

 
DOSE-ALERT® for IMBRUVICA®
 

Dose-Alert®

Dose-Alert® is a timer (like a small alarm) that helps you remember to take your medicine. The
Dose-Alert® fits on the cap of your IMBRUVICA® prescription bottle.

CARE4TODAY mobile health manager for IMBRUVICA®

Care4Today™

The Care4Today™ Mobile Health Manager is a free app for your smartphone. Unlike apps that only send reminders, the Care4Today™ Mobile Health Manager does so much more:

  • Care4Today™ tracks progress and supplies reports that you can share with your doctor

  • Care4Family™ allows you to see if your loved ones are taking their medicines

  • Care4Charity™ tells you how you can support charities by using the application. Learn more at care4today.com

Brought to you by Janssen Healthcare Innovation, an entrepreneurial team within Janssen Research & Development, LLC.

Dose-Alert is a registered trademark of Pharmaceutical Direct, Inc.
Care4Today is a trademark of Johnson & Johnson Corporation.

 

References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2017. 2. Borgsteede SD, Westerman MJ, Kok IL, Meeuse JC, de Vries TPGM, Hugtenburg JG. Factors related to high and low levels of drug adherence according to patients with type 2 diabetes. Int J Clin Pharm. 2011;33(5):779-787. 3. Ryan GW, Wagner GJ. Pill taking ‘routinization’: a critical factor to understanding episodic medication adherence. AIDS Care. 2003;15(6):795-806. 4. Dugdale DC. Taking medicine at home—create a routine. National Institutes of Health MedlinePlus. http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000613.htm. August 25, 2012. Accessed August 23, 2017. 5. Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009;19(2):167-172. 6. Tong A, Howell M, Wong G, Webster AC, Howard K, Craig JC. The perspectives of kidney transplant recipients on medicine taking: a systematic review of qualitative studies. Nephrol Dial Transplant. 2011;26(1):344-354.

 

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IMPORTANT SIDE EFFECT INFORMATION

Before taking IMBRUVICA®, tell your healthcare provider about all of your medical conditions, including if you:

  • 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
  • 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 an infection
  • 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®
    • Females should not become pregnant during treatment and for 1 month after the last dose of IMBRUVICA®
    • Males should avoid getting female partners pregnant during treatment and for 1 month after the last dose of IMBRUVICA®
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA® or breastfeed

Tell your healthcare provider about all the medicines you take, 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.

How should I take IMBRUVICA®?

  • Take IMBRUVICA® exactly as your healthcare provider tells you to take it
  • Take IMBRUVICA® 1 time a day
  • Swallow IMBRUVICA® capsules and tablets whole with a glass of water
  • Do not open, break, or chew IMBRUVICA® capsules
  • Do not cut, crush, or chew IMBRUVICA® tablets
  • Take IMBRUVICA® at about the same time each day
  • 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 are the possible side effects of IMBRUVICA®?

IMBRUVICA® may cause serious side effects, including:

  • 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, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time
  • 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®
  • 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
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter). Serious heart rhythm problems and death have happened in people treated with IMBRUVICA®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint
  • 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
  • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs
  • 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.

The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL)  include:

  • Diarrhea

  • Bruising

  • Muscle and bone pain

  • Tiredness

  • Rash

  • Fever

  • Nausea

 

The most common side effects of IMBRUVICA® in adults with cGVHD include:

  • Tiredness

  • Bruising

  • Diarrhea

  • Mouth sores (Stomatitis)

  • Muscle spasms

  • Nausea

  • Pneumonia

  • Tiredness

  • Mouth sores (Stomatitis)

  • Pneumonia

  • Bruising

  • Muscle spasms

  •  

  • Diarrhea

  • Nausea

 

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.

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. 

General information about the safe and effective use of IMBRUVICA®

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.

Please see the full Important Product Information.

INDICATIONS

What is IMBRUVICA® (ibrutinib)?

IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with:

  • Mantle cell lymphoma (MCL) who have received at least one prior treatment
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
  • Waldenström's macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
  • 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.


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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).

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