MSEvents | GILENYA Events | GILENYA (fingolimod)
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`Important Safet
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`formation | Full Prescribing Information (PDF)| Patient Medication Guide (PDF)
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`WHY GILENYA? ASKFORGILENYA STARTGILENYA CONNECTWITHGILENYA
`FOR CHILDREN 10-17
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`For US Residents Only
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`GILENYA Events
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`Rehshetta S.
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`PRINT
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`GET YOUR QUESTIONS
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`PRie)
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`People herehave taken GILENVA and have beencompensatedfor their time. Thepatients featured may nolonger be taking GILENYA today
`
`ATTEND A GILENYA EVENT
`Medical specialists and GILENYA Guideshostlive eventsall over the United States.It's a great
`way to get some answers—and make somefriendsin the process.
`Find an event near you.
`om °°
`
`
`
`
`Whyattend a GILENYA Event?
`There's no better way to learn about GILENYAthanto talk to people who knowit inside and
`out. That's why we offer these events—so you can get together with GILENYA Guides and
`other people whe are speaking out against their relapsing multiple sclerosis (MS).
`But the real star of these events is you. Every GILENYA Eventgives you the opportunity to ask
`questionslike, "What got you interested in GILENYAinthefirst place?"
`You'll also hear from medical specialists, who will talk about relapsing MS and treatment with
`GILENYA. They cantell you quite a bit about what their experience has been whenprescribing
`GILENYA,as well as how their patients are doing.
`So whatare you waiting for? Get your questions answered by a real person, face-to-face.
`Pretty easy, right?
`
`
`
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`G6
`!'M PART OF A COMMUNITY
`THAT FIGHTS BACK
`TOGETHER.
`
`- ScottM 33
`YOU CAN USE OUR RESOURCES TO HELP
`YOU FIGHT BACK. SIGN UP NOW. >
`
`NEXT: MEET THE GILENYA GUIDES >
`
`“GILENYAcanresult in a slow heart rate whenfirst taken. You will be observed by a health care professionalfor at least 6 hours
`after you take yourfirst dose. You may need to repeatthis monitoring if you miss @ doseor are a child whois moving to 0.5 mg
`
`ASK FOR GILENYA
`Are you ready for onepill,
`once a day*? Gettips for
`talking to your doctor about
`GILENYA.
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`6o->
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`HOW GILENYA WORKS
`What sets GILENYAapart?It's
`all in the details: see GILENYA
`in action.
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`Go7>
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`"HEY MS, TAKE THIS!"
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`J
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`REAL PEOPLE SPEAK OUT >
`Anne Indiana
`“| have been on Gilenya for
`several years. Since | have
`been on 0 morelesions
`have appeared"
`Ana Florida
`"HEY MS,Take This!| dare
`you to break my spirit.”
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`POST YOUR MESSAGE
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`Fi CHECKUSOUTONFACEBOOK!
`The conversation continues
`on our Facebook page, where
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`People who have
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`SUPPORT From relapsing ms with
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`DEPOSITION
`2
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`EXHIBIT ,iB
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`https://www.gilenya.com/c/living-with-ms/events?site=P$068242&gclid=COaB07CppOUCF SOMswod72EMMQ[10/17/2019 7:38:25 PM]
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`Biogen Exhibit 2216
`Mylanv. 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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`from the 0.25 mg dose
`
`INDICATION
`
`GILENYA ts a prescription medicine usedto treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-
`remilting disease, and active secondary progressive disease, in adults and children 10 years of age and older
`
`IMPORTANT SAFETY INFORMATION
`
`You should not take GiLENYAif in the last 6 months you experienced heart attack, unslable angina, stroke or mini-stroke {transient ischemic
`attack or TIA), or certain types of heart failure. Do not take GILENYAif you haveanirregular or abnormal heartbeat(arrhythmia), including a
`heart finding called protonged QT as seen on an ECG, orif you take medicines that change your heart rhythm. Do not take GILENYAif you are
`allergic to fingolimad or any of the other ingredients
`
`GILENYA may cause serious side effects such as:
`* Slow heart rate, especially after first dase. Adults and children will be monitored by a health care professicnal for at least 6 hours after the
`first dose or after a child takes the first dose of 0.5mg of GILENYA when switching fram 0.25mg daily dose. Your pulse and blood pressure
`will be checked hourly. You'll get an ECG before and 6 haursafter your first dose.
`If any heart prablems arise or your heart rate is still low,
`you'll continue to be monitored.If you have any serious side effects, especially those that require treatment with other medicines, orif you
`have certain types of heart problerns, or if you're taking medicines that can affect your heart, you'll be watched overnight.
`If you experience
`slow heart rate, it will usually return to normal within 1 manth. Call your doctor, or seek immediate medical attention if yau have any
`symptoms of slow heart rate, such as dizziness,tiredness, feeling like your heart is bealing slowlyor skipping beats, or chest pain
`Symptoms can happen up to 24 hours after the first dose. Cail your doctor if you miss 1 or more dases of GILENYA—yau may need to
`repeat the 6-hour monitoring.
`Increased risk of serious infections, same of which could belife threatening and cause death. You should not receivelive 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. GILENYA lowers the number of white blood cells (lymphacytes) in your blood. This will usually go back to normal within 2
`months of stopping GILENYA. Your doctor may do a bland tesl to check your white blood cells before you start GILENYA.Call your doctor
`right away if, while taking GILENYAorfor 2 monthsafter your last dose, you have fever, tiredness, body aches, chills, nausea, vomiting, or
`headache accompanied by fever, neckstiffness, sensitivity to light, nausea, and/or canfusion. These may be symptoms of meningitis.
`* Progressive multifocal leukoencephalopathy (PML). PML 's a rare brain infection that usually leads to death or severe disability.
`If PML
`happens,it usually happensin people with weakened immune systems but has happened in people who do not have weakened immune
`systems. Call your doctorright away if you have any new or worsening symptoms of PML. that have lasted several days, including changes
`in your thinking of memory, changesin your vision, decreased strength, problems with balance, weakness on 1 side of 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 of the same vision symptoms as an MS attack(optic neuritis), or no symptoms.If it
`happens, macular edema usually starts in the first 3 to 4 months after starting GILENYA. Your doctor shauld test your vision before you
`start GILENYA, 3 ta 4 monthsafter you start GILENYA, and any time you natice vision changes. Vision problems may cantinue after
`macular edema has gone away. Your risk of macular edemais higher if you have diabetes or have had an inflammation of your eye
`(uveitis). Call your doctor right away if you have blurriness, shadaws, or a blind spot in the center of your vision; sensitivity to light; or
`unusually colored vision.
`Swelling and natrowing 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, if left
`untreated, it may lead to a stroke. Call your doctor right away if you experience any symptoms, such as sudden severe headache, sudden
`confusion, seizures, or suddenlossofvision.
`Liver damage. Your doctor should do blood tests to check yourliver before you start GILENYA andperiodically during treatment. Call your
`doctar right away if you have nausea, vomiting, stomachpain, tiredness, loss of appetite, dark urine.or if your skin or the whites of your
`eyes turn yellow
`Breathing problems. Some patients have shartness of breath. Call your doctor right away if you have trouble breathing.
`" Severe worsening of MS after stopping GILENYA. Many people who have worsening of MS symptomsafter stopping GILENYA do not
`return to the level of function that they had before or during treatment with GILENYA. This can also occur in women stopping due to
`pregnancy or planning a pregnancy. This worsening happens mostoften within 12 weeks after stopping GILENYA, butcan happenlater,
`Do not stap taking GILENYA without talking with your doctor. Tell your doctor if you have worsening symptoms of MSafter stopping
`GILENYA.
`Increasesin bload pressure (BP). BP should be monitored during treatment.
`* Cancers including basal and Merkel cell carcinoma and melanoma. Tell your doctorif you have any changesin the appearance of your
`skin, including changesin a mole, new darkened area in your skin, a sore that does not heal, or growths on your skin such as a bumpthat
`may be shiny, pearly while, 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 with a high sun protection factor and wearprotective clothing. Lymphoma has also occurred in patients
`receiving GILENYA,
`
`GILENYA may harm your unborn baby. Talk to your dactorif 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 monthsafter stopping.If you become pregnant while taking
`GILENYA, or within 2 months after stopping, tell your doctor right away.It is not known if GILENYA passesinto breast milk. Talk to your doctor
`about the best way to feed your baby if yau take GILENYA. A pregnancy registry is available for women who became pregnant during GILENYA
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`https://www.gilenya.com/c/living-with-ms/events?site=PS068242&gclid=COaB07CppOUCFSOMswod72EMMQ[10/17/2019 7:38:25 PM]
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`MSEvents | GILENYA Events | GILENYA(fingolimod)
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`treatment. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by e-mailing
`gpr@quintiles.com, or by going to www.gilenyapregnancyregistry.com.
`
`Tell your doctor about all your medical conditions, including if you had or now have an irregular or abnormal heartbeat; stroke or mini-stroke;
`heart problems;a history of repeated fainting; a feverorinfection, orif 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 orliver problems;
`or uncontrolled high blood pressure. Also tell your doctor if you have had chicken pox or have received the chicken pox vaccine. Your doctor
`maytest for the chicken pox virus, and you may need to get the full course of the chicken pox vaccine and wait 1 month beforestarting
`GILENYA. Children 10 years and older should complete their vaccination schedule before starting GILENYA.
`
`If you take too much GILENYA,call your doctor or go to the nearest hospital emergency room right away
`
`Tell your doctor aboutall the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and
`herbal supplements.
`
`The most commonside effects with GILENYA were headache, abnormalliver tests, diarrhea, cough, flu, sinusitis, back pain, abdominal pain,
`and pain in armsorlegs.
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`In the pediatric study:
`+ The safety in children 10 years and older receiving GILENYA wassimilar to that seen in adults
`+ The rate of seizures was higher in GILENYA-treated patients comparedto that of a leading injectable
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`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www fda gov/medwatchor call 1-800-FDA-1088.
`
`cH weteh
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`A NOW_Visit PatientAssistanceNow.com to see if you are eligible
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`WHYGILENYA?
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`Why Choose GILENYA?
`How GILENYA Works
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`Gilenya.com
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`Temms of Use
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`Ask Your Doctor AboutGILENYA
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`https://www.gilenya.com/c/living-with-ms/events?site=PS068242&gclid=COaB07CppOUCFSOMswod72EMMQ| 10/17/2019 7:38:25 PM]
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