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IMBRUVICA® (ibrutinib)—Your ally
to help fight Waldenström’s
Macroglobulinemia
An oral therapy you
take once a day, on
your own, at a time
and place convenient
for you
What is IMBRUVICA®?
IMBRUVICA® is a prescription medicine used to treat people with:
• Waldenström’s macroglobulinemia (WM)
It is not known if IMBRUVICA® is safe and effective in children.
Important Safety Information
IMBRUVICA® may cause serious side effects, including: bleeding problems,
infections, decrease in blood cell counts, heart rhythm problems, second
primary cancers, tumor lysis syndrome, and kidney problems. Please review the
Important Product Information in back pocket.
The information in this brochure is not intended to replace the advice of
your doctor. If you have any questions about your IMBRUVICA® treatment,
be sure to contact your healthcare team.
Please review the Important Safety Information on pages 2 and 8-10
and Important Product Information in back pocket.
IMPORTANT SAFETY INFORMATION
Medicine can have side effects. The following serious side effects
have been reported in people taking IMBRUVICA®:
• Bleeding problems can happen during treatment with IMBRUVICA®
that can be serious and may lead to death. 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, feel dizzy or weak, confusion, change in your
speech, or a headache that lasts a long time. Your risk of bleeding may
increase if you are also taking a blood thinner medicine.
• 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 while taking 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 (atrial fibrillation and atrial flutter). Heart
rhythm problems 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.
• Second primary cancers. New cancers have happened in people who
have been treated 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.
• Kidney problems. Kidney failure and death have happened in people
with MCL receiving IMBRUVICA® treatment.
This is not a complete list of side effects, and others may occur.
Tell your doctor if you think you are experiencing side effects.
Please review the additional Important Safety Information on
pages 8-10 and Important Product Information in back pocket.
2
WM
You have been diagnosed with WM, and by now you know what to
expect. But here’s a quick review of what happens with the disease.
In lymphoma,
cancerous B cells
grow out of
control and crowd
out the healthy
blood cells.
WM is a rare type
of lymphoma that
usually progresses
slowly.
WM occurs when your body makes too
many B cells, which crowd out healthy
blood cells in your bone marrow
The abnormal B cells release excess IgM
antibodies into the blood, causing a
variety of adverse symptoms
What is IMBRUVICA®?
You were prescribed IMBRUVICA® because you were diagnosed with WM
and may have experienced WM symptoms such as low blood counts,
clumping of proteins in your blood, nerve pain, or other immune symptoms.
• IMBRUVICA® is a medicine you take by mouth once a day, every day
• For IMBRUVICA® to work, it is very important to take it every day
exactly the way your doctor tells you to
B CELLS
A B cell is a type of
white blood cell,
also called a B
lymphocyte, that
makes antibodies
to fight infections.
IgM ANTIBODY
A special type of
antibody that is
made by B cells.
In WM, too much
IgM is produced.
IMBRUVICA® works differently
• It works by blocking a specific protein in B cells, called Bruton’s
tyrosine kinase, or BTK
• By blocking BTK, IMBRUVICA® may slow the spread of WM
• Because BTK is also found in some normal cells, blocking it may
cause side effects. These are explained later in this guide
BTK
A special protein
that influences
how B cells grow
and multiply.
IMBRUVICA®— A partner in your
treatment journey
With IMBRUVICA®, you, your doctor, and
your entire healthcare team have
a new partner in managing your WM.
3
About
IMBRUVICA®
Living with Waldenström’s Macroglobulinemia (WM)
IMBRUVICA® (ibrutinib)—An oral therapy
you take once a day, on your own, at a time
and place convenient for you
Because an oral medicine can be taken at home, you have the
responsibility to remember to take your medicine as directed by
your doctor.
See page 6 for tips on remembering to take IMBRUVICA®.
How to take IMBRUVICA®
CONSISTENT
DOSING
Do not change
the dose or
stop taking
IMBRUVICA®
unless your doctor
tells you to.
• Take IMBRUVICA® capsules whole, by mouth, once a day with a
full glass of water. Do not open, break, or chew
• Do not stop taking IMBRUVICA® without talking to
your doctor
• Try to take IMBRUVICA® at approximately the same
time each day
• Drink plenty of water throughout the day while
you’re taking IMBRUVICA®
• IMBRUVICA® is available only by prescription
• Refill your prescription before you run out so you can take it as
your doctor prescribed it
• Store IMBRUVICA® in its original container, with the lid tightly closed,
at room temperature from 68°F to 77°F (20ºC to 25ºC)
While Taking IMBRUVICA®:
• Do not drink grapefruit juice
• Do not eat grapefruit
• Do not eat Seville oranges, which are
often used in making marmalade
These products may increase
the amount of IMBRUVICA® in
your blood.
Tell your doctor about any medicine, vitamins, or
herbal supplements you are taking; some may
interact with IMBRUVICA®.
Please review the Important Safety Information on pages 2 and 8-10
and Important Product Information in back pocket.
4
Clinical trial experience
with IMBRUVICA®
Effectiveness of IMBRUVICA®
In a trial of 63 patients with previously treated WM, 62% had a
response to IMBRUVICA®.
Your doctor will monitor your response to treatment
with IMBRUVICA®
Taking
IMBRUVICA®
• Your doctor may obtain additional tests (such as blood tests and
CT scans) to evaluate and confirm your response to IMBRUVICA®
• You and your treatment team will decide on the best plan for you
What should I know about side effects
with IMBRUVICA®?
IMBRUVICA® may cause side effects. In the clinical trial, 6% of patients
stopped taking the drug, and 11% of patients took a lower dosage
because of side effects.
The most common side effects in the clinical trial
• Low white blood cell count
• Low blood platelet count
• Diarrhea
• Rash
• Nausea
• Muscle spasms
• Fatigue
This is not a complete list of side effects, and others may
occur. Tell your doctor if you think you are experiencing
side effects.
5
Establish a routine to remember your daily
IMBRUVICA® (ibrutinib) dose
Keep in mind that your involvement is important to the success of your
treatment. Because IMBRUVICA® is a medication you take at home, only
you can make sure that you’re taking it every day the way your doctor
prescribed it. It’s helpful to develop a routine for taking IMBRUVICA®
so you don’t risk missing a dose.
What to do if you miss a dose
TALK TO YOUR
HEALTHCARE
TEAM ABOUT SIDE
EFFECTS
If you are having
any side effects,
remember to talk
to your healthcare
team. Your doctor
may adjust your
treatment.
Mistakes can happen. If you forget 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 are not sure what to do.
Tell your doctor about any upcoming surgeries
Your doctor may stop IMBRUVICA® for a brief time before or after
any surgery, medical or dental procedure, or before starting
some medications. Your doctor will tell you when to start taking
IMBRUVICA® again.
Tips to help you remember to take IMBRUVICA®
Take your IMBRUVICA® at the same time, morning or night.
REMEMBER
TO TAKE
IMBRUVICA®
EVERY DAY
IMBRUVICA®
only works if
you take it
every day, the
way your doctor
directed, even
if you are not
having any
symptoms.
Keep a calendar where you can record the time you
take your IMBRUVICA® dose each day.
Set an alarm to alert you when it’s time to take
your IMBRUVICA®.
Time your IMBRUVICA® treatment to your daily walk.
Ask a family member or friend to remind you when
it’s time to take your IMBRUVICA®.
Please review the Important Safety Information on pages 2 and 8-10
and Important Product Information in back pocket.
6
Surround yourself with support
As you move through your WM treatment journey with IMBRUVICA®,
always keep in touch with your healthcare team and don’t hesitate to
ask questions. Your doctors, nurses, and pharmacists all bring specific
types of expertise to your care, and are ready to answer your questions
and provide you with support.
You are also part of a wider support community:
• Relationships with family and friends can provide valuable support
as you manage your condition and treatment. Don’t be afraid to turn
to them for support
TEAM SUPPORT
Your doctors,
nurses, and
pharmacists
can answer
questions about
your condition,
treatment options,
medications, and
side effects.
• More formal support groups are also available, where you can meet
other people living with WM or other cancers. Your doctor and
treatment facility should be able to provide you with contacts to
groups in your area
Tips and Resources
• Additionally, you can enroll in the YOU&iTM Support Program. See page
11 to learn more about this personalized support program that is
available for people being treated with IMBRUVICA®
Stay informed and motivated
These online resources are a good start for finding information about
advances in treatment options for WM, support groups, resources,
and events in your area.
American Cancer Society: www.cancer.org
CancerCare: www.cancercare.org
Cancer Support Community:
www.cancersupportcommunity.org
Leukemia & Lymphoma Society: www.lls.org
Lymphoma Research Foundation: www.lymphoma.org
National Comprehensive Cancer Network (NCCN):
www.nccn.org/patients
International Waldenström’s Macroglobulinemia
Foundation: www.iwmf.com
Patient Advocate Foundation: www.patientadvocate.org
Powerful Patient: www.powerfulpatient.org
Advocacy Connector: www.advocacyconnector.com
7
IMPORTANT SAFETY INFORMATION
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING
IMBRUVICA® (ibrutinib)?
Before you take 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. You should not become pregnant while taking
IMBRUVICA®.
• are breastfeeding or plan to breastfeed. You and your healthcare
provider should decide if you will take IMBRUVICA® or breastfeed.
You should not do both.
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 whole with a glass of water. Do not open,
break, or chew IMBRUVICA® capsules.
• 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 2 doses of IMBRUVICA® on the same day to
make up for a missed dose.
WHAT SHOULD I AVOID WHILE TAKING IMBRUVICA®?
• You should not drink grapefruit juice, eat grapefruit, or eat Seville
oranges (often used in marmalades) while you are taking IMBRUVICA®.
These products may increase the amount of IMBRUVICA® in your blood.
8
WHAT ARE THE POSSIBLE SIDE EFFECTS OF IMBRUVICA®?
IMBRUVICA® may cause serious side effects, including:
• Bleeding problems can happen during treatment with IMBRUVICA® that
can be serious and may lead to death. 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, feel dizzy or
weak, confusion, change in your speech, or a headache that lasts a long
time. Your risk of bleeding may increase if you are also taking a blood
thinner medicine.
• 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 while taking 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 (atrial fibrillation and atrial flutter).
Heart rhythm problems 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.
• Second primary cancers. New cancers have happened in people who have
been treated with IMBRUVICA®, including cancers of the skin or other organs.
Important
Safety Information
• 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.
• Kidney problems. Kidney failure and death have happened in people with
MCL receiving IMBRUVICA® treatment.
The most common side effects of IMBRUVICA® include: diarrhea, tiredness,
muscle and bone pain, bruising, nausea, upper respiratory tract infection,
and rash.
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.
Please review the Important Product Information in back pocket.
9
IMPORTANT SAFETY INFORMATION
(continued)
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.
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.
Please review the Important Product Information in back pocket.
10
– Discover a World of Support
The YOU&i™ Support Program is a personalized program that includes
information on access and affordability, nurse call support, and resources
for patients being treated with IMBRUVICA®.
Access Support
• Provides you with rapid (within 2 days) benefits investigation
• Provides you with information about the prior authorization process
• Provides you with information about the insurance appeals process
• Refers you to a specialty pharmacy for processing and delivery of your medication
• YOU&iTM Start - If you are experiencing an insurance coverage decision delay,
this program may give you access to IMBRUVICA®
• Eligible patients who have been prescribed IMBRUVICA® for an
FDA-approved indication, and who are experiencing an insurance
coverage decision delay greater than 5 business days, can receive a free
30-day supply of IMBRUVICA®
• If decision delay persists, an additional free 30-day supply may be provided
• The free product is offered to eligible patients without any
purchase contingency or other obligation
Affordability Support
• YOU&iTM Instant Savings Program – If you have commercial health insurance
and meet eligibility requirements, you will pay no more than $10 per month for
IMBRUVICA®
• Month refers to a 30-day supply. Subject to a maximum benefit, 12 months
after first prescription fill or 12 monthly fills (1-year supply), whichever comes
first, unless the maximum dollar benefit has been reached
TO ENROLL IN
YOU&iTM
SUPPORT
PROGRAM
visit
www.
youandisupport.
com
or call
1-877-877-3536,
Monday through
Friday
8 AM – 8 PM ET.
• Not valid for patients enrolled in Medicare or Medicaid
• Foundation Referral: If you need additional financial support, we can
provide you with information on independent foundations that may be able
to provide financial support
Other Resource:
The Johnson & Johnson Patient Assistance Foundation (JJPAF)
is committed to providing access to medicines for uninsured individuals who lack the
financial resources to pay for them. If you need IMBRUVICA® and are uninsured and
unable to pay for your medicine, please contact a JJPAF program specialist at
1-800-652-6227 from 9:00 AM to 6:00 PM ET, or visit the foundation website at
www.jjpaf.org to see if you might qualify for assistance.
Nurse Call Support & Resources
YOU&i™
Support Program
• Informational phone calls with YOU&iTM nurses about IMBRUVICA® and
your disease
• Ongoing tips, tools, and other resources sent through mail, email, and text
• Patient Starter Kits for new IMBRUVICA® patients
11
See the inside back cover to learn about
the YOU&iTM Support Program
To receive more information as it becomes available,
visit www.IMBRUVICA.com or call 1-877-877-3536.
Please review the Important Safety Information on pages 2 and 8-10.
Please review the accompanying Important Product Information in back pocket.
© Pharmacyclics, Inc. 2015
© Janssen Biotech, Inc. 2015
02/15
PRC-00759