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`HOW ZYTIGA (abiraterone acetate) WORKS
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`https://www.zytiga.com/about-zytiga/how-zytiga-works
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`11/16/2016
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`AVENTIS EXHIBIT 2159
`Mylan v. Aventis, IPR2016-00712
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`How ZYTIGA® (abiraterone acetate) Works
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`Page 2 of 6
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`https://www.zytiga.com/about-zytiga/how-zytiga-works
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`11/16/2016
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`How ZYTIGA® (abiraterone acetate) Works
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`Who should not take ZYTIGA (abiraterone acetate)?
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`Do not take ZYTIGA if you are pregnant or may become pregnant. ZYTIGA
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`may harm your unborn baby. Women who are pregnant or who may become
`pregnant should not touch ZYTIGA without protection, such as gloves.
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`ZYTIGA is not for use in women or children. Keep ZYTIGA and all medicines out of the reach of children.
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`Before you take ZYTIGA , tell your healthcare provider if you:
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`Have heart problems
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`Have liver problems
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`Have a history of adrenal problems
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`Have a history of pituitary problems
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`Have any other medical conditions
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`Plan to become pregnant (See "Who should not take ZYTIGA ?")
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`Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA passes into your breast milk. You and your
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`healthcare provider should decide if you will take ZYTIGA or breastfeed. You should not do both. (See "Who
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`should not take ZYTIGA ?")
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`Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal
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`supplements. ZYTIGA can interact with many other medicines.
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`If you are taking ZYTIGA :
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`Take ZYTIGA and prednisone exactly as your healthcare provider tells you.
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`https://www.zytiga.com/about-zytiga/how-zytiga-works
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`11/16/2016
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`Take your prescribed dose of ZYTIGA one time a day. Your healthcare provider may change your dose if needed.
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`Do not stop taking your prescribed dose of ZYTIGA or prednisone without talking to your healthcare provider first.
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`Take ZYTIGA on an empty stomach. Do not take ZYTIGA with food. Taking ZYTIGA with food may cause
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`more of the medicine to be absorbed by the body than is needed and this may cause side effects.
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`No food should be eaten 2 hours before and 1 hour after taking ZYTIGA .
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`Swallow ZYTIGA tablets whole. Do not crush or chew tablets.
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`Take ZYTIGA tablets with water.
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`Your healthcare provider will do blood tests to check for side effects.
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`Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment
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`with ZYTIGA . If their female partner may become pregnant a condom and another form of birth control must be
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`used during and for one week after treatment with ZYTIGA . Talk with your healthcare provider if you have any
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`questions about birth control.
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`If you miss a dose of ZYTIGA or prednisone, take your prescribed dose the following day. If you miss more than 1
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`dose, tell your healthcare provider right away.
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`ZYTIGA may cause serious side effects including:
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`High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention
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`(edema).
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`Tell your healthcare provider if you get any of the following symptoms:
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`Dizziness
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`Fast heartbeats
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`Feel faint or lightheaded
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`Headache
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`Confusion
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`Muscle weakness
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`Pain in your legs
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`Swelling in your legs or feet
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`Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.
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`Liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood
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`tests to check your liver before treatment with ZYTIGA and during treatment with ZYTIGA . Liver failure may
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`occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes:
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`Yellowing of the skin or eyes
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`Darkening of the urine
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`Severe nausea or vomiting
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`The most common side effects of ZYTIGA include:
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`Weakness
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`Joint swelling or pain
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`Swelling in your legs or feet
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`Hot flushes
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`Diarrhea
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`Vomiting
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`Cough
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`High blood pressure
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`Shortness of breath
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`Urinary tract infection
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`Bruising
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`Low red blood cells (anemia) and low blood potassium levels
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`High blood sugar levels, high blood cholesterol and triglycerides
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`https://www.zytiga.com/about-zytiga/how-zytiga-works
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`11/16/2016
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`How ZYTIGA® (abiraterone acetate) Works
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`Certain other abnormal blood tests
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`Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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`THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA .
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`FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST.
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`Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
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`medicines, vitamins, and herbal supplements.
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`ZYTIGA can interact with other medicines.
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`You should not start or stop any medicine before you talk with the healthcare provider that prescribed ZYTIGA .
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`Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when
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`you get a new medicine.
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`Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of
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`prescription drugs to the FDA.
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`Visit www.fda.gov/medwatch (http://www.fda.gov/medwatch), or call 1-800-FDA-1088 (1-800-332-1088).
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`051527-160418
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`WHAT IS ZYTIGA ?
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`ZYTIGA (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA is used to treat
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`men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that
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`lower testosterone) that has spread to other parts of the body.
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`Last updated July 2016.
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`https://www.zytiga.com/about-zytiga/how-zytiga-works
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`11/16/2016
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`
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`How ZYTIGA® (abiraterone acetate) Works
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`Page 6 of 6
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`(http://www.janssen.com)
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`https://www.zytiga.com/about-zytiga/how-zytiga-works
`
`11/16/2016