MS Events | GILENYA Events | GILENYA (fingoiimod)
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`WHY GILENVA? ASK FOR GILENYA START GILENYA
`CONNECTWITH GILENYA
`FOR CHILDREN 10-17
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`For US Resrdents Only
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`GILENYA Events
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`GET YOUR QUESTIONS
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`ATTEND A GILENYA EVENT
`Medical specialists and GILENYA Guides host live events ali over the United States. It's a great
`way to get some answers—and make some friends in the process.
`Find an event near you.
`
`
`
`
`
`ZIP a
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`Why attend a GILENYA Event?
`There's no better way to learn about GILENYA than to talk to people who know it inside and
`out. That's why we offer these eventsiso you can get together with GILENYA Guides and
`other people who are speaking out against their relapsing multiple sclerosis (MS).
`But the real star of these events is you. Every GILENYA Event gives you the opportunity to ask
`questions like, "What got you interested in GILENYA in the first place?"
`You'll also hear from medical specialists, who will talk about relapsing MS and treatment with
`GILENYA. They can tell you quite a bit about what their experience has been when prescribing
`GILENYA. as well as how their patients are doing.
`So what are you waiting for? Get your questions answered by a real person face—to-face,
`‘
`7
`Pretty easy. right.
`
`ASK FOR GiLENYA
`Are you ready for one pill,
`once a day'? Get tips for
`talking to your doctor about
`GILENYA.
`
`60—)
`
`HOW GELENYA WORKS
`What sets GILENYA apart? It's
`all in the details: see GILENYA
`in action.
`
`60-)
`
`"HEY MS, TAKE THIS!’I
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`-
`
`REAL PEOPLE SPEAK DUT D
`Anne Indiana
`”i have been on Gilenya for
`several years Since l have
`been on El more lesions
`have appeared"
`
`i
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`"HEV MS, Take ThisI ldare
`you to break my spirit."
`
`Ana Florida
`
`POST YOUR MESSAGE —)
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`'1 mmwrowm
`The conversation continues
`on our Facebook page, where
`people are trading tips, getting
`mama. and sharing stories
`COME SEE WHAT WERE ALL
`—)
`ABOUT!
`.
`
`SU o.
`
`Fenple who have
`experience fighting
`back against
`relapsing MS with
`G‘LE“*“,‘i5f°Ve”
`233.33.“ °
`[WATCH VIDEO]
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`
`
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`‘ ‘
`I‘M PART or A COMMUNITY
`THAT FIGHTS BACK
`TOGETHER.
`chottM ’5
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`YOU CAN USE OUR RESOURCES TO HELP
`YOU FIGHT BACK. SIGN UP NOW. -)
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`DEPOSITION
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`EXHIBIT 1:
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`ozma.
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`'GILENYA can result in a slow heart rate when first lakan. You will be observed by a health care professional tor at least 6 hours
`after you lake your first dose You may need in repeat this rnonilnnng it you mass a dose or are a Child who is moi/trig to 0.5 mg
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`NEXT. MEEr THE GILENYA GUEDES —)
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`https :f/Www.gilenya.Com/c/living-with«ms/events?site=PSO6 8242&gclid=COaB07CppOUCF SOMswod7ZEMMQU 0/ 1 7/20 1 9 7:3 8:25 PM]
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`Biogen Exhibit 2216
`Mylan v. Biogen
`IPR 2018-01403
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`Biogen Exhibit 2216
`Mylan v. Biogen
`IPR 2018-01403
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`MS Events | GILENYA Events | GILENYA (fingolimod)
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`Iron-i the 0.25 mg dose
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`INDICATION
`
`GILENYA is a prescription medicrne used to treat relapsing Iorms oi’ multiple sclerosis (MS). to include clinically isolated syndrome, relapsing—
`rerriiltlng disease, and active secondary progressive disease, in adults and children 10 years of age and older
`
`IMPORTANT SAFETY INFORMATION
`
`You should not take GlLENYA it in the last 6 months you experienced heart attack, unstable angina, stroke or minirstroke (transient rschemic
`attack or TIA}, or certain types at heart failure Do not take GILENYA it you have an irregular or abnormal heartbeat {arrhythmia}. including a
`heart Finding called protonged QT as seen on an ECG. or it you take medicines that change your heart rhythm. Do not take GlLENYA it you are
`allergic to fingolimod or any at the other ingredients
`
`GILENYA may cause serious side effects such as:
`' Slow heart rate, especratiy alter firstdose. Adults and chitdren will be monitored by a health care professional for at least 6 hours after the
`lust dose or after a child takes the first dose of 0.5mg of GILENYA when SWitching from 0.25mg daily close, Your pulse and blood pressure
`will be checked hourly. You'll get an ECG before and 6 hours after your tirst dose If any heart problems arise or your heart rate is still low,
`you'll continue to be monitored. It you have any serious side effects, especially those that require treatment With other medicrnes, or it you
`have certain types of heart problems. or it you're taking medicines that can affect your heart. you‘ll be watched overnight
`it you experience
`slow heart rate. it Will usually return to normal Within 1 month Call your doctor, or seek immediate medical attention if you have any
`symptoms of slow heart rate, such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain
`Symptoms can happen up to 24 hours after the first dose. Catl your doctor if you miss 1 or more doses oi GlLENYA—you may need to
`repeat the 6-hour monitoring.
`‘ Increased risk of serious Infections, some of which could be life threatening and cause death. You should not receive two vaccines during
`treatment with GILENYA and For 2 months after you stop taking GILENYA. Vaccines may not work as well when given during treatment
`With GILENYA. GELENYA lowers the number of white blood cells (lymphocytes: in your blood. This WlII usually go back to normal Within 2
`months of stopping GILENYA. Your doctor may do a blood test to check your white blood cells before you start GILENYA. Call your doctor
`right away if, while taking GILENYA or tor 2 months after your last close. you have fever, tiredness body aches, chills, nausea, vomiting, or
`neadache accompanied by fever. neck stiffness, sensitiVity to light, nausea, andlor contusion. These may be symptoms of meningitis.
`' Progressive multrlocal leukoencephalopathy (PML). PML is a rare brain inlectiori that usually leads to death or severe disability ll PML
`happens, it usually happens in people With weakened immune systems but has happened in people who do not have weakened immune
`systems. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including changes
`in your thinking or memory, changes in your Vision, decreased strength, problems With balance, weakness on 1 side or your body, loss of
`coordination in your arms and legs. confusion, or changes in your personality.
`' Macular edema, a vision problem that can cause some ofthe same vision symptoms as an MS attack (optic neuritis), or no symptoms. It it
`happens, macutar edema usually starts in the first 3 to 4 months after starting GlLENYA. Your doctor should test your vision before you
`start GILENYA. 3 to 4 months after you start GILENYA, and any time you notice Vision changes. Visron problems may continue after
`macular edema has gone away. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye
`(uveitrs) Call your doctor right away if you have biurriness, shadows. or a blind spot in the center at your vision; sensdivity to light: or
`unusualiy colored visron.
`' Swelling and narrowrng of the blood vessels in your brain, A condition called PRES (posterior reversible encephalopathy syndrome) has
`happened rarely in adults taking GILENYA Symptoms of PRES usually get better when you stop taking GILENYA. However, it let!
`untreated, it may lead to a stroke. Call your doctor right away it you experience any symptoms, such as sudden severe headache, sudden
`coniusron, seizures, or sudden loss of vision.
`" Liver damage. Your doctor should do blood tests to check your liver before you start GtLENYA and periodically during treatment. Call your
`doctor right away if you have nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine. or ityour skin or the whites of your
`eyes turn yellow
`' Breathing problems Some patienls have shortness of breath. Get: your doctor right away it you have trouble breathing.
`' Severe worsening of MS after stopping GILENYA. Many people who have worsentng of MS symptoms after stopping GILENYA do not
`return to the level of function that they had laeiote or during treatment with GILENVA. This can also occur in women stopping due to
`pregnancy or planning a pregnancy. This worsening happens most often within ‘i 2 weeks alter stopping GILENYA, butcan happen later,
`Do not stop taking GtLENYA without talking with your doctor. Tell your doctor if you have worsening symptoms of MS after stopping
`GILENYA.
`' Increases in blood pressure (HP). HP should be monitored during treatment.
`‘ Cancers including basal and Market cell carcinoma and melanoma. Tell your doctor if you have any changes in the appearance of your
`skin, including changes in a mole, new darkened area in your skin, a sore that does not heat, or growths on your skin such as a bump that
`may be shiny, pearly white. skin colored, or pink. While taking GILENYA, limit the amount of time you spend in sunlight and ultraviolet (UV)
`light as well as use sunscreen WlII'I a high sun protection factor and wear protective clothing. Lymphoma has also occurred in patients
`receiving GILENYA.
`
`GILENYA may harm your unborn baby. Talk to your doctor if you are pregnant or planning to become pregnant. Women who can become
`pregnant should use effective birth control While on GILENYA, and for at least 2 months after stopping, If you become pregnant while taking
`GILENYA, or within 2 months after stopping, tell your doctor right away It is not known if GtLENYA passes into breast milk. Talk to your doctor
`about the best way to feed your baby if you take GiLENYA. A pregnancy registry is available for women who become pregnant durtng GILENYA
`
`https://www.gilenya.com/c/living—with-ms/events‘?site:PS068242&gc1id=COaB07CppOUCFSOMswod72EMMQ[10/l 7/2019 7:38:25 PM]
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`MS Events | GILENYA Events i GILENYA (fingolimod)
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`treatment. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1w577-598-7237, by e-rnaiiing
`gpr@qumiiles corn, or by going to www,giienyapregnancyregistryicoz'n.
`
`Tell your doctor about all your medical conditions, including if you had or now have an irregular or abnormal heartbeat; stroke or minivstroke,
`heart problems; a history of repeated fainting; a fever or infection, or if you are unable to fight infections due to a disease or are taking medicines
`that lower your immune system, including corticosteroids, or have taken them in the past; eye problems, diabetes: breathing or liver problems;
`or uncontrolled high mood pressure. Also tell your doctor if you have had chicken pox or have received the chicken pox vaccrne. Your doctor
`may test for the chicken pox vims, and you may need to get the full course of the chicken pox vaccrne and wait 1 month before starting
`GILENYA. Children 10 years and order should complete their vaccination scheduie before siartrng GlLENYA.
`
`if you take too much GiLEN‘r’A, cail your doctor or go to the nearest hospital emergency room right away
`
`Tell your doctor about all the medrCines you take or have recently taken! inctudirig prescription and over-the-counter medic-mes, vitamins> and
`herbal supplements
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`The most common Side effects with GILENYA were headache. abnormal liver tests, diarrhea. cough, flu. sinusitis back pain: abdominal pain,
`and path in arms or legs.
`
`in the pediatric study:
`- The safety in children 10 years and older receivrng GILENYA was similar to that seen in adults
`- The rate of seizures was higher in GlLENYA~treeied patients compared to that of a leading injectabie
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. VESii www tda govfrnedwatci’i or call 1-BOOAFDA~1088.
`
`R“ Assffigfigé
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`A NOW Visit PatientAssistanceNow.com to see if you are eligible
`PBAA‘iBD'lElS 3114
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`WHY GILENYA?
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`ASK FOR GILENYA
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`START GILENYA
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`CONNECT WITH GILENYA
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`FOR CHILDREN 10-17
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`Why Choose GILENYA?
`How GILENYA Wells
`GILENYA Saiety
`FAQS
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`slimy-Jam
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`Terms 01‘ Use
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`important Saiety lniorrnatr'on
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`https:l/www.gtlenya.com/c/living—with-ms/events?site:PS068242&gclid=COaBO7CppOUCFSOMswod72EMMQ[ 1 0/17/2019 7:38:25 PM]
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