Download Beginning Your Treatment.

Important information
for patients starting
ZYTIGA®.
Beginning
Your Treatment.
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
Answers Start Here.
Your doctor has prescribed ZYTIGA® (abiraterone acetate)
as your next treatment option. You probably have a lot of questions,
and this booklet is a great place to start finding the answers.
What’s Inside:
What Is mCRPC?
3
What Is The Role Of Androgen?
3
What Is ZYTIGA®?
3
How Does ZYTIGA® Work?
3
What Should I Know About ZYTIGA®?
How Do I Take ZYTIGA®?
6–13
14
Where Can I Find Information And Resources?
16–17
What Are My Cost Support Options?
18–19
How Do I Get My ZYTIGA®?
More Support For Your Journey
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
20
21–22
2
What Is mCRPC?
Metastatic castration-resistant prostate cancer (mCRPC) is a form of
advanced prostate cancer that is resistant to medical (e.g., hormonal)
or surgical treatments that lower testosterone, and has spread to other
parts of the body. In other words, your prostate cancer has progressed
on androgen deprivation* therapy (ADT) and has spread to other parts
of the body.
What Is The Role
Of Androgen?
Androgens like testosterone are male hormones the body produces
naturally, but when you have metastatic castration-resistant prostate
cancer (mCRPC), androgens can help fuel the tumor.
What Is ZYTIGA®
(abiraterone acetate)?
ZYTIGA® (zy-tee-ga) is an oral, once-daily medication used in
combination with prednisone to treat metastatic castration-resistant
prostate cancer, a type of advanced prostate cancer that is resistant to
medical (eg, hormonal) or surgical treatments that lower testosterone,
and has spread to other parts of the body.
How Does
ZYTIGA® Work?
ZYTIGA® works by interrupting
the androgen-making process at an
important step. It inhibits androgen
production at three sources—the testes,
the adrenal glands, AND the tumor itself.
*Androgen deprivation – A treatment to suppress or block the production or action of
male hormones. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD:
National Cancer Institute, 2013. Available at www.cancer.gov/dictionary. Accessed 4/29/2016.)
3
ZYTIGA® may cause serious side effects including:
High blood pressure (hypertension), low blood potassium
levels (hypokalemia), and fluid retention (edema).
Tell your healthcare provider if you get any of the following symptoms:
•Dizziness
• Fast heartbeats
• Feel faint or lightheaded
•Headache
•Confusion
• Muscle weakness
• Pain in your legs
• Swelling in your legs or feet
Adrenal problems may happen if you stop taking prednisone,
get an infection, or are under stress.
Liver problems. You may develop changes in liver function blood
tests. Your healthcare provider will do blood tests to check your liver
before treatment with ZYTIGA® and during treatment with ZYTIGA®.
Liver failure may occur, which can lead to death. Tell your healthcare
provider if you notice any of the following changes:
•
•
•
Yellowing of the skin or eyes
Darkening of the urine
Severe nausea or vomiting
Continued On Next Page
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
4
Continued From Prior Page
Before you take ZYTIGA® (abiraterone acetate),
tell your healthcare provider if you:
Have heart problems
Have liver problems
Have a history of adrenal problems
Have a history of pituitary problems
Have any other medical conditions
Plan to become pregnant
(See “Who should not take ZYTIGA®?”)
Are breastfeeding or plan to breastfeed. It is not known
if ZYTIGA® passes into your breast milk. You and your
healthcare provider should decide if you will take
ZYTIGA® or breastfeed. You should not do both.
(See “Who should not take ZYTIGA®?”)
Take any other medicines, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
ZYTIGA® can interact with many other medicines.
5
What Should I Know
About ZYTIGA®?
ZYTIGA® plus prednisone is a treatment option for men
with mCRPC (prostate cancer that is resistant to medical or surgical
treatments that lower testosterone, and has spread to other parts
of the body).
ZYTIGA® is the first oral, once-daily medication for mCRPC.
Since its approval in 2011, more than 80,000 men in the U.S.
have been prescribed ZYTIGA®.*
* Estimate based on sales and use data from April 2011 to December 2015.
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
6
Clinical Study Results.
In a clinical study of 1,088 men with mCRPC whose disease
had progressed while on androgen deprivation therapy (ADT)
and had not received prior chemotherapy:
Certain men who received ZYTIGA® (abiraterone acetate) plus prednisone
lived longer than men who received placebo* plus prednisone.
The median overall survival1 was 34.7 months for the group of men
who received ZYTIGA® plus prednisone compared to 30.3 months
for the group of men who received placebo plus prednisone.
Please speak to your doctor about what this may mean to you.
MEDIAN OVERALL SURVIVAL
34.7
30.3
Men who had received
ZYTIGA® plus prednisone
Men who had received
placebo plus prednisone
MONTHS
MONTHS
*Placebo – An inactive substance or treatment that looks the same as, and is given the same way
as, an active drug or treatment being tested. (National Cancer Institute: NCI Dictionary of Cancer
Terms. Bethesda, MD: National Cancer Institute, 2013. Available at www.cancer.gov/dictionary.
Accessed 4/29/2016.)
MEDIAN
TIMEisTO
STARTING
The median
overall survival
the length
of time fromCHEMOTHERAPY
assigned study group to the time when half of
the patients in the group diagnosed with the disease are still alive in a clinical trial. (National Cancer
Institute:
of Cancer Terms. Bethesda, MD: National Cancer Institute, 2013. Available at
Men NCI
whoDictionary
had
MONTHS
www.cancer.gov/dictionary.
Accessed 4/29/2016.)
received ZYTIGA®
plus prednisone
1
25.2
16.8
7
Continued On Next Page
Men who had
received placebo
plus prednisone
MONTHS
Continued From Prior Page
In the same study, at a planned analysis, fewer men with mCRPC had
disease progression as measured by imaging studies in the group who
received ZYTIGA® plus prednisone, compared to the group who
received placebo plus prednisone.
28% (150 of 546) of men who received ZYTIGA® plus prednisone
had progression, as measured by imaging studies.
46% (251 of 542) of men who received placebo plus prednisone
had progression, as measured by imaging studies.
Please speak to your doctor about what this may mean to you.
The Most Common Side Effects
Of ZYTIGA® (abiraterone acetate) Include:
•Weakness
•Joint swelling or pain
•Swelling in your legs or feet
•Hot flushes
•Diarrhea
•Vomiting
•Cough
•High blood pressure
•Shortness of breath
•Urinary tract infection
•Bruising
•
Low red blood cells
(anemia) and low blood
potassium levels
•
High blood sugar levels,
high blood cholesterol
and triglycerides
•
Certain other abnormal
blood tests
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
Continued On Next Page
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
8
34.7
MONTHS
30.3
MONTHS
Clinical Study Results Continued
Men who had received
ZYTIGA® plus prednisone
Men who had received
placebo plus prednisone
ZYTIGA® (abiraterone acetate) plus prednisone delayed the beginning
of chemotherapy compared to placebo plus prednisone in certain men
with mCRPC.
MEDIAN TIME TO STARTING CHEMOTHERAPY
Men who had
received ZYTIGA®
plus prednisone
Men who had
received placebo
plus prednisone
25.2
16.8
MONTHS
MONTHS
Clinical Study Results
Summarized.
As you have seen, in a clinical study at a planned analysis, certain men
with mCRPC who received ZYTIGA® plus prednisone lived longer and the
median time their disease did not progress as measured by imaging studies
was longer, compared to those who received placebo plus prednisone.
ZYTIGA® plus prednisone also delayed the start of chemotherapy
in certain men with mCRPC as compared to placebo plus prednisone.
Talk to your doctor to see if ZYTIGA® is right for you.
9
What Are The Potential
Side Effects Of ZYTIGA®
(abiraterone acetate)?
IMPORTANT SAFETY INFORMATION
Who should not take ZYTIGA®?
Do not take ZYTIGA® if you are pregnant or may become pregnant.
ZYTIGA® may harm your unborn baby. Women who are pregnant
or who may become pregnant should not touch ZYTIGA® without
protection, such as gloves.
ZYTIGA® is not for use in women or children. Keep ZYTIGA®
and all medicines out of the reach of children.
Before you take ZYTIGA®, tell your healthcare provider
if you:
Have heart problems
Have liver problems
Have a history of adrenal problems
Have a history of pituitary problems
Have any other medical conditions
Plan to become pregnant (See “Who should not take ZYTIGA®?”)
Continued On Next Page
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
10
Continued From Prior Page
Before you take ZYTIGA® (abiraterone acetate),
tell your healthcare provider if you:
Are breastfeeding or plan to breastfeed. It is not known if
ZYTIGA® passes into your breast milk. You and your healthcare
provider should decide if you will take ZYTIGA® or breastfeed.
You should not do both. (See “Who should not take ZYTIGA®?”)
Take any other medicines, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
ZYTIGA® can interact with many other medicines.
If you are taking ZYTIGA®:
Take ZYTIGA® and prednisone exactly as your healthcare
provider tells you.
Take your prescribed dose of ZYTIGA® one time a day.
Your healthcare provider may change your dose if needed.
Do not stop taking your prescribed dose of ZYTIGA®
or prednisone without talking to your healthcare provider first.
Take ZYTIGA® on an empty stomach. Do not take ZYTIGA®
with food. Taking ZYTIGA® with food may cause more of the
medicine to be absorbed by the body than is needed and this
may cause side effects.
No food should be eaten 2 hours before and 1 hour
after taking ZYTIGA®.
Swallow ZYTIGA® tablets whole. Do not crush or chew tablets.
Take ZYTIGA® tablets with water.
Your healthcare provider will do blood tests to check
for side effects.
Continued On Next Page
11
Continued From Prior Page
Men who are sexually active with a pregnant woman must use
a condom during and for one week after treatment with ZYTIGA®.
If their female partner may become pregnant, a condom and
another form of birth control must be used during and for one
week after treatment with ZYTIGA®. Talk with your healthcare
provider if you have any questions about birth control.
If you miss a dose of ZYTIGA® or prednisone, take your prescribed
dose the following day. If you miss more than 1 dose, tell your
healthcare provider right away.
ZYTIGA® may cause serious side effects including:
High blood pressure (hypertension), low blood potassium
levels (hypokalemia), and fluid retention (edema).
Tell your healthcare provider if you get any of the following symptoms:
•Dizziness
• Fast heartbeats
• Feel faint or lightheaded
•Headache
•Confusion
• Muscle weakness
• Pain in your legs
• Swelling in your legs or feet
Adrenal problems may happen if you stop taking prednisone,
get an infection, or are under stress.
Liver problems. You may develop changes in liver function blood
tests. Your healthcare provider will do blood tests to check your liver
before treatment with ZYTIGA® and during treatment with ZYTIGA®.
Liver failure may occur, which can lead to death. Tell your healthcare
provider if you notice any of the following changes:
•
•
•
Yellowing of the skin or eyes
Darkening of the urine
Severe nausea or vomiting
Continued On Next Page
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
12
Continued From Prior Page
The Most Common Side Effects Of
ZYTIGA® (abiraterone acetate) Include:
•Weakness
•Joint swelling or pain
•
Swelling in your legs
or feet
•Hot flushes
•Diarrhea
•Vomiting
•Cough
•High blood pressure
•Shortness of breath
•Urinary tract infection
•Bruising
•
Low red blood cells
(anemia) and low blood
potassium levels
•
High blood sugar levels,
high blood cholesterol
and triglycerides
•
Certain other abnormal
blood tests
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF
ZYTIGA®.
FOR MORE INFORMATION, ASK YOUR HEALTHCARE
PROVIDER OR PHARMACIST.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
ZYTIGA® can interact with many other medicines.
You should not start or stop any medicine before you talk with the
healthcare provider that prescribed ZYTIGA®.
Call your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription
drugs to the FDA.
Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088 (1-800-332-1088).
051527-160418
Know the medicines you take. Keep a list of them with you to show to
your healthcare provider and pharmacist when you get a new medicine.
13
How Do I Take ZYTIGA®
(abiraterone acetate)?
Take ZYTIGA® and prednisone exactly as your healthcare
provider tells you.
ZYTIGA® is a once-daily, oral medication you can take at home. The
recommended dose of ZYTIGA® is 1,000 mg (four 250-mg tablets)
administered orally once daily in combination with prednisone 5 mg
administered orally twice daily. Your healthcare provider can change
your dose if needed.
Take ZYTIGA® on an empty stomach. Do not take ZYTIGA®
with food. Taking ZYTIGA® with food may cause more of the
medicine to be absorbed by the body than is needed and this
may cause side effects.
No food should be eaten 2 hours before and 1 hour
after taking ZYTIGA®.
Swallow ZYTIGA® tablets whole. Do not crush or chew tablets.
Take ZYTIGA® tablets with water.
Do not stop taking your prescribed
dose of ZYTIGA® or prednisone
without talking with your healthcare
provider first.
Tablets shown are not actual size.
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
14
What Else Should I Keep In
Mind When Taking ZYTIGA®
(abiraterone acetate)?
The recommended dose of ZYTIGA® is 1,000 mg
(four 250-mg tablets) administered orally once daily in
combination with prednisone 5 mg administered orally twice daily.
Take your prescribed dose of ZYTIGA® one time a day.
Your healthcare provider may change your dose if needed.
Your healthcare provider will do blood tests to check
for side effects.
While taking ZYTIGA® you will also take prednisone.
Because of the way ZYTIGA® works, certain side effects may
occur. Prednisone may help decrease the occurrence and severity
of these side effects. For more information, talk to your doctor.
Men who are sexually active with a pregnant woman must use
a condom during and for one week after treatment with ZYTIGA®.
If their female partner may become pregnant, a condom and
another form of birth control must be used during and for one week
after treatment with ZYTIGA®. Talk with your healthcare provider
if you have questions about birth control.
If you miss a dose of ZYTIGA® or prednisone, take your prescribed
dose the following day. If you miss more than 1 dose, tell your
healthcare provider right away.
15
Where Can I Find
Information And Resources?
ZytigaOne® Support, your ZytigaOne® Support Case
Coordinator and a host of other useful resources are available
to provide support that may help you throughout
your journey with ZYTIGA®.
Working With ZytigaOne® Support.
You or your doctor can choose to use ZytigaOne® Support
as a convenient resource for services and information.
ZytigaOne® Support may investigate your insurance benefits
to understand your coverage for ZYTIGA® by request from your
prescriber, or you may call ZytigaOne® Support to start this
process yourself.
If your prescriber requested this for you, a ZytigaOne®
Support Case Coordinator will be contacting you shortly
to explain your benefits.
1-855-ZYTIGA-1 (998-4421)
Monday–Friday, 8:00 AM–8:00 PM ET
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
16
Real People,
Personalized Support.
The ZytigaOne® Support Case Coordinators are the heart
of ZytigaOne® Support. Your personally assigned ZytigaOne®
Support Case Coordinator can:
Assess your insurance coverage and call you to explain
your insurance benefits and potential medication
out-of-pocket expenses.
Provide information on cost support options, such as
an instant savings program or referral to a patient assistance
program, as appropriate for eligible patients.
Provide additional support, such as a weekly cost support status call,
monthly prescription reminders, and educational materials
delivered to your email or front door.
Coordinate with a specialty pharmacy to arrange for efficient
handling and shipment of your ZYTIGA® (abiraterone acetate).
17
What Are My
Cost Support Options?
A ZytigaOne® Support Case Coordinator can speak to you about
several options for helping you manage your out-of-pocket costs for
treatment, whether you have commercial insurance, government
insurance such as Medicare, or are uninsured. If you choose to receive
this service, a ZytigaOne® Support Case Coordinator can call you on a
regular basis to check on the status of your support and can even keep
your prescriber in the loop by sending them a status report.
If You Have Commercial Insurance:
The ZytigaOne® Instant Savings Program.
This savings program is available to eligible patients with
commercial insurance and may help with out-of-pocket costs.
Your ZytigaOne® Support Case Coordinator will determine your
eligibility and explain the benefits of enrollment.
Eligible patients pay no more than $10 per month*
for their ZYTIGA® prescription after activating their card.
BIN:
GROUP:
MEMBER:
SEE REVERSE • RESTRICTIONS APPLY
*Per calendar year, subject to a $12,000
annual program benefit or a one-year
supply, whichever comes first.
Not valid for patients enrolled
in Medicare Part D or Medicaid.
Other restrictions may apply.
Please read the accompanying Important Product
Information for ZYTIGA® (abiraterone acetate) and
discuss any questions you have with your doctor.
ZytigaOne® Support is in no way an extension of medical treatment provided by healthcare
professionals for individual patients. The program goal is to provide additional information and
customer service for patients receiving treatment with ZYTIGA®. The ZytigaOne® Support program
may be discontinued at any time. You may discontinue your participation at any time by calling
1-855-ZYTIGA-1 (998-4421).
Please see Important Product Information and talk to your doctor if you have any questions.
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
18
If You Have Commercial Insurance, Medicare,
Medicaid, or TRICARE:
Independent Foundations
Your ZytigaOne® Support Case Coordinator can direct you
to alternate sources of funding through independent foundations.
Call ZytigaOne® Support for more information, including help
with understanding which foundations may be able to provide
additional support.
Foundation support may be available for ZYTIGA® (abiraterone acetate) from:
CancerCare
CancerCare.org
Phone: 1-800-813-HOPE
(1-800-813-4673)
E-mail: [email protected]
If You Are Uninsured:
Patient Access Network Foundation
Panfoundation.org
Phone: 1-866-316-PANF
(1-866-316-7263)
E-mail: [email protected]
Patient Advocate Foundation
Copays.org
Phone: 1-866-512-3861
Other Resources
Your ZytigaOne® Support Case Coordinator can also provide
you with a detailed list of other resources that may offer additional
cost support, including a patient assistance program for those
who are uninsured.
For a comprehensive list of affordability options,
visit JanssenPrescriptionAssistance.com/ZYTIGA.
19
How Do I Get My ZYTIGA®
(abiraterone acetate)?
Unlike other medications you can get at your neighborhood
drugstore, ZYTIGA® is only available through a specialty
pharmacy. These pharmacies carry certain medications and can
deliver ZYTIGA® right to your home or any location you choose.
If your prescriber sent your ZYTIGA® prescription
to ZytigaOne® Support when requesting a benefit investigation,
your ZytigaOne® Support Case Coordinator will work with your
specialty pharmacy to ensure you get your prescription.
Alternatively, your doctor may choose to send your prescription
directly to the specialty pharmacy. If you have any questions about
getting ZYTIGA®, you can always call your ZytigaOne®
Support Case Coordinator.
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
20
More Support
For Your Journey.
Advocacy Connector
Found at www.advocacyconnector.com, this tool provides
web-based oncology resources organized by different types
of cancer, including prostate. This makes it easy to find advocacy
groups that provide resources based on your needs.
My Prostate Cancer Roadmap®
Visit www.myprostatecancerroadmap.com to find a wide range
of information and resources for those who have, or care for someone
with, advanced prostate cancer. This includes perspectives and
insights from a variety of experts.
Personalized Refill Reminders
If you opt in, your ZytigaOne® Support Case Coordinator
will call you 7 days before your ZYTIGA® (abiraterone acetate)
prescription needs to be refilled to remind you to do so.
The Medication Tracker For ZYTIGA®
Available at ZYTIGA.com/begin, this printable, monthly
calendar is designed so you can create a medication schedule
that works best for you.
21
Care4Today™ Mobile Health Manager
Manage your medications from your mobile phone or computer
with Care4Today™ Mobile Health Manager. This free smartphone
app and website from Janssen Research & Development, LLC lets
you set up reminders for any kind of prescription, over-the-counter
medication, or nutritional supplement. It uses two-way messaging
so your progress reports can be shared with your healthcare
provider or caretaker. Download the free app today at the App Store,
Google Play™ or mhm.care4today.com.
Tips For Staying On Therapy
Sticking to a treatment schedule is important. These tips available
at ZYTIGA.com/begin can help you remember to take ZYTIGA®
exactly as your doctor has prescribed.
Additional Educational Materials
To opt in for more educational materials, visit ZYTIGA.com/begin
or call your ZytigaOne® Support Case Coordinator.
For more information on ZYTIGA® support tools and resources,
visit ZYTIGA.com/begin or call 1-855-ZYTIGA-1 (1-855-998-4421).
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
22
Notes:
23
Notes:
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
24
Notes:
25
Please see the Important Safety Information on pages 10–13
and click here for accompanying Important Product Information.
26
To Learn More, Visit ZYTIGA.com/begin.
Please see Important Product Information and talk to your doctor if you have
any questions.
Janssen Biotech, Inc.
800 Ridgeview Drive
Horsham, PA 19044 USA
© Janssen Biotech, Inc. 2016
05/16
035531-160304