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`CHOOSING ZYTIGA®/
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`ABOUT ZYTIGA® (abiraterone
`acetate)
`Is ZYTIGA Right for You?
`
`gilirZYTIGA® Was the #1 Prescribed Oral Medication
`for Metastatic Castration -Resistant Prostate
`Cancer in 20151
`
`ZYTIGA® is an oral, once -daily prescription medication used in combination
`with prednisone. ZYTIGA® is used to treat men with a type of prostate cancer
`called mCRPC (metastatic castration -resistant prostate cancer). This cancer is
`resistant to medical (eg, hormonal) 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.
`
`By choosing ZYTIGA ®, you are joining the more than 80,000
`men in the United States who have been prescribed
`ZYTIGA®.
`
`*Estimate is based on sales and use data from April 2011 to December 2015.
`
`References: 1. Data on file. Janssen Biotech, Inc.
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`https://www.zytiga.com/choosing-zytigatresults-of-zytiga
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`CHOOSING ZYTIGA®/
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`HOW ZYTIGA® WORKS
`
`Understanding mCRPC
`
`Before learning how treatment with ZYTIGA® works, it's helpful to understand
`how mCRPC affects your body.
`
`Watch a video about mCRPC
`
`Understanding How ZYTIGA® Works
`
`ZYTIGA® works by interrupting the androgen- making process at an important
`step. It inhibits androgen at 3 sources -the testes, the adrenal glands, AND the
`tumor itself.
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`ZYTIGA® is different from some medicines that only decrease androgen
`production in the testes and do not affect the adrenal glands or prostate tumor
`tissue.
`
`The Role of Prednisone With ZYTIGA®
`
`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.
`
`Take your prednisone exactly how your healthcare provider tells you. Do not
`stop taking your prescribed dose of ZYTIGA® or prednisone without talking to
`your healthcare provider first.
`
`Hear Ron's Story
`
`Hear patients share their experiences.
`
`https: / /www.zytiga.com/ choosing- zytiga/results -of- zytiga
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`Watch a ZYTIGA® Story
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`CHOOSING ZYTIGA®/
`
`RESULTS OF ZYTIGA®
`
`Confidence in Results of ZYTIGA®
`
`ZYTIGA® was approved by the FDA and proven effective in 2
`clinical studies
`
`In a clinical study of 1,088 men with metastatic castration -resistant prostate
`cancer, whose disease had progressed while on androgen deprivation
`therapy (ADT) and had not received prior chemotherapy, the results
`measured:
`
`Overall Survival
`
`How long men lived taking ZYTIGA® + prednisone vs placebo +
`prednisone
`
`In the clinical study, certain men who had received ZYTIGA® +
`prednisone lived longer than men taking placebo + prednisone.
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`https://www.zytiga.com/choosing-zytiga/results-of-zytiga
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`The median overall survival was 34.7 months for the group of men
`who received ZYTIGA® + prednisone vs 30.3 months for those men
`taking placebo + prednisone.
`
`Please speak to your doctor about what this may mean to you.
`View clinical study information on overall survival
`
`Disease Progression
`
`Length of time men lived without their disease getting worse or dying
`while taking ZYTIGA® + prednisone vs placebo + prednisone as
`measured by imaging studies
`
`In the same study, at a planned analysis, fewer men had progression
`as measured by imaging studies in the group who received ZYTIGA® +
`prednisone compared to the group who had received placebo +
`prednisone.
`
`65% (354 of 546) of men who received ZYTIGA® + prednisone had
`progression, as measured by imaging studies
`71 % (387 of 542) of men who received placebo + prednisone had
`progression, as measured by imaging studies
`
`Please speak to your doctor about what this may mean to you.
`View clinical study information on disease progression
`
`Delay to Chemotherapy
`
`The time to start chemotherapy in patients taking ZYTIGA® +
`prednisone vs placebo + prednisone as measured by imaging studies
`
`Also in this study, the median time to starting chemotherapy for the
`group of men taking ZYTIGA® plus prednisone was 25.2 months
`compared to 16.8 months in the group taking placebo + prednisone.
`View clinical study information on time to chemotherapy
`
`Additionally, ZYTIGA® was studied in a clinical trial of over 1,000 men with
`metastatic castrate -resistant prostate cancer who received chemotherapy
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`https: / /www.zytiga.com/ choosing- zytiga/results -of- zytiga
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`with docetaxel.
`
`Androgen deprivation -A treatment to suppress or block the production or action of male
`hormones. (National Cancer Institute: NO Dictionary of Cancer Terms. Bethesda, MD: National
`Cancer Institute. 2013. Available at www.cancer.gov /dictionary. Accessed 5/13/2016.)
`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
`5/13/2016.)
`
`Median overall survival -The length of time from either the date of diagnosis or the start of a
`clinical study or treatment for a disease, such as cancer, that half of the patients in a group of
`patients diagnosed with the disease are still alive. In a clinical trial, measuring the median overall
`survival is one way to see how well a new treatment works. Also called median survival. (National
`Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute. 2013.
`Available at www.cancer.gov /dictionary. Accessed 5/13/2016.)
`
`The most common side effects of ZYTIGA® 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.
`
`Review a list of the potential side effects of ZYTIGAC'
`
`View Potential Side Effects
`
`https: / /www.zytiga.com/ choosing -zytiga/results -of- zytiga
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`Clinical Studies I ZYTIGA® (abiraterone acetate)
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`You can get help identifying your cost support
`options to help pay for your ZYTIGA®
`
`Learn How
`
`WHAT IS ZYTIGA ®?
`ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with
`prednisone. ZYTIGA® is used to treat men with castration -resistant prostate cancer
`(prostate cancer that is resistant to medical or surgical treatments that lower
`testosterone) that has spread to other parts of the body.
`
`Important Safety Information
`Who should not take ZYTIGA® (abiraterone acetate)?
`
`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 ® ? ")
`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.
`
`https://wwwzytiga.com/choosing-zytiga/results-of-zytiga
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`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.
`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
`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
`
`The most common side effects of ZYTIGA® include:
`
`Weakness
`Joint swelling or pain
`Swelling in your legs or feet
`Hot flushes
`Diarrhea
`
`https://www.zytiga.comichoosing-zytigairesults-of-zytiga
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`8/10
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`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 other medicines.
`
`You should not start or stop any medicine before you talk with the healthcare provider
`that prescribed ZYTIGA ®.
`
`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.
`
`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).
`
`051 527- 1 6041 8
`
`© Janssen Biotech. Inc. 2016. All Rights Reserved.
`
`This site is published by Janssen Biotech. Inc., which is solely responsible for its contents. The
`material on this site is intended only as informational or as an educational aid and it is not
`intended to be taken as medical advice. The ultimate responsibility for patient care resides with a
`healthcare professional.
`
`This information is intended for the use of patients and caregivers in the United States and Puerto
`Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary
`from country to country. The Prescribing Information included here may not be appropriate for
`use outside the United States and Puerto Rico.
`
`Capitalized product names are trademarks of Janssen Biotech, Inc.
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`Last updated July 2016. 056663-161121
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