IMBRUVICA® (ibrutinib) now one pill, once daily IMBRUVICA® (ibrutinib) now one pill, once daily

INTRODUCING THE NEW FORMULATION FOR IMBRUVICA®

We’re always keeping you in mind. That’s why we developed the new formulation of IMBRUVICA®. The same IMBRUVICA® medicine that was in multiple capsules is now approved as just one pill in multiple strengths. For most patients, this will mean taking fewer pills a day after you receive your new pill prescription. We also updated the packaging to help you track your once-daily dose.

IMBRUVICA® (ibrutinib) One pill, once daily

One pill, once a day

Talk to your doctor about getting a new prescription for the same dose of IMBRUVICA® you currently take.

Most patients on IMBRUVICA® have been taking multiple capsules a day.* Once you get a new prescription for the new IMBRUVICA® pill, you will be taking just one pill, once a day, as directed by your doctor. 

The FDA approved the new one pill, once a day IMBRUVICA® because it is the same medicine at the same dose, with the same active ingredient.1† The difference is that you now take only one pill a day. The new IMBRUVICA® pill is the same size or smaller than your current capsules, depending on your prescribed dose.2 

*Based on recommended dosing.
For a full list of inactive ingredients, see the Important Product Information.
Close FAQs about the new IMBRUVICA® pill Read FAQs about the new IMBRUVICA® pill

New IMBRUVICA® pill FAQs

 
Q: Why do the pills look different?
Technology has enabled the maker of IMBRUVICA® to make one single pill that has the same amount of medicine as multiple capsules. You’re getting the same active ingredient in one pill that is the same size or smaller than the original 140-mg capsule.1,2 
 
 
Q: What should I do if I have different side effects?
Call your doctor if you have any side effects. You shouldn’t have different side effects with the switch to the new IMBRUVICA® pill because it’s the same medicine, but call your doctor if you do. There are different inactive ingredients.1 For a complete list, please see the Important Product Information.
 
 
Q: What if my doctor needs to change my dose?
If your doctor decides to change your dose, your doctor will write a new prescription for you, and you will receive a new pack.
 

If you still have questions, talk to your doctor. You can also enroll in the YOU&i™ Support Program to get answers to your questions about IMBRUVICA® and your disease, including the transition to one pill, once a day. It’s never too late to enroll!

Close FAQs
IMBRUVICA® (ibrutinib) one pill packaging

New look

IMBRUVICA® now comes in a blister pack that was designed to help you track your daily dose and transition to taking one pill a day.1

There is a 4-week supply of pills. You take one pill a day, as directed by your doctor.1

Each pill is identical. Start with Day 1. Use the space provided to note the date, or the day of the week, which can help you stay on track. The pack also lets you see whether you’ve taken your medicine, how much medicine you have left, and when you need to refill. Just take one pill each day as directed by your doctor. 

Remember to refill your IMBRUVICA® prescription before it runs out. You will see a written reminder on the package at the end of Week 3.

See how to open the package.

IMBRUVICA® (ibrutinib) 420-mg blister pack IMBRUVICA® (ibrutinib) 420-mg blister pack Sample image of the 420-mg blister pack.

Close FAQs about the package Read FAQs about the package

Package FAQs

 
Q: Why is the packaging changing from bottles to a blister pack?
The change to a blister pack was intended to help you track when you have taken your medicine, and transition to just one pill a day.
 
 
Q: Why is my prescription for a 4-week supply instead of 30 days?
Pills in this type of blister pack often come in weekly arrangements, so you can keep track of how many pills you have left and when it’s time to refill. We’ve even printed a refill reminder on the new package at the end of Week 3 to help you remember.
 
 
Q: Do I have to wait until the first of the month to start?
No, you can start taking IMBRUVICA® as directed, as soon as you receive your prescription. The printed days on the pack do not correspond to calendar days. You can also use the space provided to write in either the date, or the day of the week, to help you stay on track.
 
 
Q: Will I be able to open the new IMBRUVICA® blister pack?
Click here to watch LaVerne, a patient like you, demonstrate opening the new IMBRUVICA® blister pack.
 
 
Q: How do I store the pills?
Store IMBRUVICA® in its original packaging at room temperature between 68°F and 77°F (20°C and 25°C).1
 
Close FAQs
References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2018. 2. Data on file. Pharmacyclics LLC.

SAME MEDICINE, NEW PILL

Opening the IMBRUVICA® blister pack

Watch a video where LaVerne, a patient just like you, shows how to open the blister pack, step by step.

Instructions for using the pack

Lift the flap of the package where it says, “lift to open.” Then it’s just a few easy steps: 

Using the IMBRUVICA® Blister Pack: Step 1
STEP 1: PUSH
Push and hold the button labeled STEP 1 on the left of the package
Using the IMBRUVICA® Blister Pack: Step 2
STEP 2: PULL
While pushing the button, pull card from sleeve at the purple dot
Using the IMBRUVICA® Blister Pack: Step 3
STEP 3: TAKE
Push the pill through the blister pack and take it by mouth
Using the IMBRUVICA® Blister Pack: Step 4
STEP 4: CLOSE
To close the pack, fold the flap over before pushing it back in.

How to take the new IMBRUVICA® pill

You’ll get a new prescription from your doctor at your specific dose. When you fill that new prescription, there will be a 4-week supply of pills.

Each pill is identical. Start with Day 1. Use the space provided to note the date, or the day of the week, which can help you stay on track. The pack also lets you see whether you’ve taken your medicine, how much medicine you have left, and when you need to refill. Just take one pill each day as directed by your doctor. 

Remember to refill your IMBRUVICA® prescription before it runs out. You will see a written reminder on the package at the end of Week 3.

Daily IMBRUVICA® Routine

Most other things about your daily IMBRUVICA® routine should stay the same1

  • Take the IMBRUVICA® pill by mouth at about the same time each day with a glass of water 

  • Swallow the pill whole. Do not open, break, cut, crush, or chew it

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

  • Do not take more than one pill per day. If you mistakenly take more than one pill per day, call your doctor or go to the nearest hospital emergency room right away

Missing an IMBRUVICA® Dose

If you miss a dose, take it as soon as you remember on the same day1

  • 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

  • Call your doctor or pharmacist if you have any questions

Taking IMBRUVICA®

While taking IMBRUVICA®

  • Do not drink grapefruit juice

  • Do not eat grapefruit

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

These products may increase the amount of IMBRUVICA® in your blood. 

Close FAQs about how to take IMBRUVICA® Read FAQs about how to take IMBRUVICA®

How to take the new IMBRUVICA® pill FAQs


Q: What do I do if I take more than one pill in a day?
If you mistakenly take more than one pill in a day, call your doctor or go to the nearest hospital emergency room right away.
 

Q: Can I cut the pill in half or crush it?
No. Please be sure to take your IMBRUVICA® as prescribed. Do not open, break, cut, crush, or chew the pill.1  
 
 
Q: Do I have to take it with food?
No, you don’t need to take IMBRUVICA® with food. Take it at about the same time each day with a glass of water, as directed by your doctor.1
 
Close FAQs
Reference: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2018.
 

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YOU&i™ Support Program

Connect to personalized IMBRUVICA® support:
access, affordability support options, and nurse call support and resources

IMBRUVICA® (ibrutinib) Access Support
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that simplifies access
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IMBRUVICA® (ibrutinib) Affordability Support Options
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If you are eligible and have
commercial health insurance,
you pay no more than
$10 per prescription* for
IMBRUVICA®
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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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