10/6/2016
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`How Xofigo (radium Ra 223 dichloride) injection May Help
`
`I
`IMPORTANT SAFETY INFORMATION
`Do not take Xofigo ifyou are pregnant or may become pregnant. Xofigo can harm your unborn baby. Women who are pregnant or
`who may become pregnant should not come in contact with Xofigo without protection, such as gloves. Continue reading below
`
`I
`
`I
`
`About Xofigo
`
`What Is Xofigo® Used for?
`
`Xofigo (zo-FEEG-oh) is an intravenous (IV) injection ofthe radioactive material radium 223. It is used to treat prostate cancer that is resistant to medical or
`surgical treatments that lower testosterone and has spread to your bones with symptoms, but not to other parts ofyour body. The medical term for this
`condition is metastatic castration-resistant prostate cancer, or mCRPC.
`
`What to Expect When Being Treated With Xofigo
`
`Indication
`
`Xofigo® (radium Ra 223 dichloride) injection is used to treat prostate cancer that is resistant to medical or surgical treatments that lower testosterone and
`has spread to your bones with symptoms, but not to other parts ofyour body. The medical term for this condition is metastatic castration-resistant prostate
`cancer, or mCRPC.
`
`Important Safety Information
`Do not take Xofigo ifyou are pregnant or may become pregnant. Xofigo can harm your unborn baby. Women who are pregnant orwho may become pregnant
`should not come in contact with Xofigo without protection, such as gloves.
`
`Before taking Xofigo, tell your healthcare provider if you:
`- have bone marrow problems. Xofigo can cause your blood cells counts to go down, including red blood cells, white blood cells, and/or platelets. In a
`clinical trial, some patients had to permanently discontinue therapy because of bone marrow problems. In addition, there were some deaths and blood
`transfusions that occurred due to severe bone marrow problems. Your healthcare providerwill do blood tests before and duringtreatment with Xofigo
`- are receiving any chemotherapy or another extensive radiation therapy
`- have any other medical conditions
`
`While you are on Xofigo:
`- make sure you keep your blood cell count monitoring appointments and tell your healthcare provider about any symptoms or signs of low blood cell
`counts. Report symptoms or signs ofshortness of breath, tiredness, bleeding (such as bruising), or infection (such as fever)
`- stay well hydrated and report any signs ofdehydration (such as dry mouth and increased thirst), or urinanj or kidney problems (such as burning when
`urinating)
`there are no restrictions regarding contact with other people after receiving Xofigo
`follow good hygiene practices in order to minimize radiation exposure from spills of bodily fluids to household members and caregivers for a period of
`one week after each injection
`- use condoms and make sure female partners who may become pregnant use highly effective birth control methods during and for a minimum ofsix
`months after treatment with Xofigo
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`-
`-
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`The most common side effects of Xofigo include:
`- nausea
`- diarrhea
`- vomiting
`-
`swelling ofthe arms or legs (peripheral edema)
`-
`low blood cell counts
`
`Tell your healthcare provider ifyou have any side effects that botheryou or do not go away.
`
`You are encouraged to report negative side effects or quality complaints ofprescription drugs to the FDA. Visit www.fda.gov[medwatch, or call
`1-800-FDA-1088. For important risk and use information about Xofigo, please see the Full Prescribing Information.
`
`https://www.xofi go-us.com/pati ent/about-xofi go/
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`AVENTIS EXHIBIT 2167
`Mylan v. Aventis, IPRZO16-00712
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`AVENTIS EXHIBIT 2167
`Mylan v. Aventis, IPR2016-00712
`
`

`
`10/6/2016
`
`How Xofigo (radium Ra 223 dichloride) injection May Help
`
`HII}-'i‘I' H['EHIhCilI'['
`© 2016 Bayer. BAVER. the Bayer Cross, Xnfigo, and the Xofigo Access Services logo are registered trademarks of Bayer.
`
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