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7/23/2015
`
`HOW ZYT|GA® (abiraterone acetate) <Ibr>WORKS
`
`Zytiga'
`(abraterone acetate)
`250 mg tablets
`
`ZYT|GA® Inhibits Androgen Production at 3 Sources-
`lncluding the Tumor Itself
`
`Oral, once-daily ZYTIGA® works by interrupting the androgen-making process at an important step. ZYTlGA® inhibits a key step in androgen
`production at three sources:
`the testes‘
`
`the adrenal glands2
`, AND the tumor itself. Watch the following videos to learn How ZYTIGA® Worlsz
`
`How ZYTIGA® Works
`TESTES
`
`4» )8
`
`$1
`
`ADRENAL
`
`
`
`PROSTATE TUMOR TISSUE
`
`You may be aware that the male body naturally produces hormones called androgens.3 The most well known androgen in men is testosterone. For
`men with mCRPC, androgens play a role in fueling the disease. While not the only source, androgen is produced primarily in the testes and some
`is also produced by the adrenal glands, which are located above the kidneys. We know now that the tumor itself is also a source of androgen
`production. While there are other key factors that contribute to the disease, androgen is one such factor.
`
`Reducing the production of androgen is key in helping you and your doctor manage your illness.
`
`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
`
`Oral, once-daily ZY11GA® works by interrupting the androgen-making process at an important step.
`
`htlpsz/lvvwwzytigacorn/print/about-zytigalhow-zytiga—works
`
`ARGENTUM EX1066
`E
`lVl
`Page 1
`
`Page 1
`
`

`

`WHAT IS ZYTIGA ?
`
`ZYTIGA  (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA  is used to treat men with castration­resistant


`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 nonprescription 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 prescr bed 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.
`Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment with ZYTIGA . If their sexual

`partner may become pregnant a condom and another form of birth control must be used during and for one week after treatment with ZYTIGA .

`Ta k with your healthcare provider if you have any questions about birth control.
`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
`
`7/23/2015
`
`HOW ZYTIGA® (abiraterone acetate) </br>WORKS
`
`https://www.zytiga.com/print/about­zytiga/how­zytiga­works
`
`2/4
`
`Talk with your doctor ﴾https://www.zytiga.com/doctor‐discussion‐guide﴿ to see if ZYTIGA is right for you.

`
`The testes are two egg‐shaped male reproductive organs located in the scrotum. They produce sperm and the male hormone, testosterone.
`
`The adrenal glands are endocrine glands that sit at the top of the kidneys.
`
`Androgens are hormones produced by the body that control the development and maintenance of masculine characteristics.
`
`1 2 3
`
`Page 2
`
`

`
`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 test. Your healthcare provider will do blood tests to check your liver before
`treatment with ZYTIGA  and during treatment with ZYTIGA .


`
`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.
`
`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 nonprescription medicines, vitamins, and herbal
`supplements.
`
`ZYTIGA  can interact with many other medicines.

`
`You should not start or stop any medicine before you ta k with the healthcare provider who prescr bed 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 (http://www.fda.gov/medwatch), or call 1­800­FDA­1088 (1­800­332­1088).
`
`© Janssen Biotech, Inc. 2015. All rights reserved.
`
`This site is published by Janssen Biotech, Inc. (http://www janssenbiotech.com), which is solely responsible for its contents. The material on this site is intended only as informa ional
`or as an educa ional aid and it is not intended to be taken as medical advice. The ultimate responsibility for pa ient care resides with a heal hcare professional.
`
`This information is intended for  he 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.
`
`LEGAL NOTICE (/LEGAL­NOTICE) | PRIVACY POLICY (/PRIVACY­POLICY) | CONTACT US
`(HTTP://WWW JANSSENBIOTECH.COM/CONTACT­US)  |  PATIENT INFORMATION (/SHARED/PRODUCT/ZYTIGA/ZYTIGA­PATIENT­
`INFORMATION.PDF)  |  IMPORTANT PRODUCT INFORMATION (/SHARED/PRODUCT/ZYTIGA/ZYTIGA­PRESCRIBING­
`INFORMATION.PDF)  |  SITE MAP (/SITEMAP)  ABOUT JANSSEN BIOTECH, INC. (HTTP://WWW.JANSSENBIOTECH.COM)  |
`UNSUBSCRIBE (/UNSUBSCRIBE)  |  HOME (/)
`
`LAST UPDATED APRIL 21, 2015
`
`7/23/2015
`
`HOW ZYTIGA® (abiraterone acetate) </br>WORKS
`
`https://www.zytiga.com/print/about­zytiga/how­zytiga­works
`
`3/4
`
`Page 3
`
`

`
`(http://www.janssenbiotech.com/)
`
`Source URL:https://www.zytiga.com/about‐zytiga/how‐zytiga‐works
`
`7/23/2015
`
`HOW ZYTIGA® (abiraterone acetate) </br>WORKS
`
`https://www.zytiga.com/print/about­zytiga/how­zytiga­works
`
`4/4
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`Page 4

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