Biogen Patient Support Program |Tecfidera® {dimethyl fumarate)
`17/31 [2019
`
`
`Patient Information & Prescribing information
`
`Emigrant Safety Information
`
`
`4} Tecfldera
`{dmetiiyi tomarateii
`
`The Mam MS program from Biogen
`
`ABOVEaftEE
`
`Sometimes it helps to know that you're not facing relapsing multiple sclerosis EMS] alone. Your healthcare provider is your first source
`of information. but Biogen~the maker of Tecfidera® [dimethyt fumaratei—is also here to support you through its Above MSm services.
`
`Byjoining Above MS. you'll get tips. tools. and personalized assistance for your MS. including:
`
`4: Specially tailored information from people who are living with relapsing MS
`-
`Insights from expert contributors in fields such as financial planning. cooking. exercise. and many other areas
`0 Free access by phone to Nurse Educators 24/7
`0 A variety of financial and insurance support services. and our $0 Copay Program [if you're eligible]
`0
`Information about TECFEDERA treatment and support services
`s Help finding assistance via charitable organizations to cover items such as insurance premiums. copays, and transportation needs
`o Educational webinars and live events in your area
`- Support is available in Spanish
`
`Join today )
`
`Nurse Educators
`
`Whether you'rejust starting treatment or have been on treatment for a white. Nurse Educators can provide you and your care partner
`with additional support and respond to questions you may have. Our Nurse Educators are icnowtedgeable and highly educated in
`multiple sclerosis [MS]. They are aEl registered nurses. and many are MS-certified or working toward their M5 certification. They can:
`
`- Answer questions about relapsing MS treatment. common symptoms. and side effects
`0 Provide you with support through MS education
`a Hetp you plan conversations with your heaithcare provider
`a Connect you with the services and support that are available to you
`
`Although Nurse Educators can be a great resource ioryou. please keep in mind that your healthcare profitder is always your primary
`resource when it comes to your relapsing MS and your treatment.
`
`
`Call 1-890—456—2255 to connect with a Nurse Educator 2M7. or sign up at AboveM5.com. Support is available in
`
`Spanish.
`
`We aim recommend
`
`IMPORTANT SAFETY iNFORMATION AND ENDICATIDN
`
`EMPDRTANT SAFETY IN FORMATION
`
`EXHIBIT
`
`COLLAPSE [67g
`
`Do not use Tecfidera® ldirnethyl furnaratel if you have had an allergic reaction [such as welts. hives, swelting of the face. lips. mouth or
`tongue. or difficulty breathing] to TECFIDERA or any of its ingredients. Read More
`
`Before taking and while you take TECFIDERA. tell your healthcare provtder about any low white blood cell counts or infections or any
`other medical conditions.
`
`IMPORTANT SAFETY ENFORMATION AND INDICATION
`
`COLLAPSE
`
`IMPORTANT SAFETY INFORMATION
`
`ht‘lps:flwww.tecfidera.comlen_usihomeladditionaI—supportlbiogen-patient-Supporthtmi
`
`113
`
`MYLAN PHARMS. INC. EXHIBIT 1072 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1072 PAGE 1
`
`

`

`TI31I2019
`
`Biogen Patient Support Program |Tecfidera® (dimethyl fumarate)
`
`Do not use Tecfidera® [dimethyl fumaratel ii you have had an allergic reaction [such as weits. hives. swelling of the face. tips. mouth or
`tongue, or difficulty breathing} to TECFIDERA or any of its ingredients.
`
`Before taking and while you take TECFIDERA. teli your healthcare provider about any low white blood cell counts or infections or any
`other medical conditions.
`
`What are the possible side effects of TECFIDERA?
`
`TECFIDERA may cause serious side effects including:
`a Altergic reactions
`
`5 PML, which is a rare brain infection that usually leads to death or severe disabiiity.
`
`e Decreases in your white blood cell count. Your healthcare provider shoutd check your white blood cell count before you take
`TECFIDERA and from time to time during treatment
`
`a Liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking TECFIDERA and
`during treatment if needed. Teli your healthcare provider right away if you get any symptoms of a liver problem during treatment.
`including:
`0 severe tiredness
`
`0 loss ofappetite
`
`0 pain on the right side of your stomach
`0 dark or brown [lea color) urine
`
`0 yellowing of your skin or the white part of your eyes
`
`The most common side effects of TECFIDERA include flushing aod stomach problems. These can happen especially at the start of
`treatment and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Cali your healthcare provider if these
`symptoms bother you or do not go away. Ask your healthcare provider if taking aspirin before taking TECFEDERA may reduce flushing.
`
`These are not all the possible side effects of TECFIDERA. Call your healthcare provider for medical advice about side effects. You may
`report side effects to FDA at 1—gQg~FDA—1HBB. For more information go to diilymedmlmmihgovj.
`
`Tetl your healthcare provider if you are pregnant or plan to become pregnant. or breastfeeding or plan to breastfeed. It is not known if
`TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also tell your healthcare provider if you are taking
`prescription or over-the-counter medicines. vitamins, or herbal suppiements. Ifyou take too much TECFIDERA. call your heaithcare
`provider or go to the nearest hospital emergency room right away.
`
`Please see full Prescribing Information and Patient Information.
`
`This is not intended to replace discussions with your healthcare provider.
`Indication
`
`TECFiDERA is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.
`
`The most common side effects of TECFIDERA include flushing and stomach problems. These can happen especially at the start of
`treatment and may decrease over time. Taking TECFIDERA with food may help reduce ftushing. Call your healthcare provider if
`these symptoms bother you or do not go away. Ask your healthcare provider if taking aspirin before taking TECFIDERA may reduce
`Rushing.
`
`These are not ail the possible side eifects of TECFIDERA. Cail your healthcare provider for medical advice about side effects. You
`may report side effects to FDA at1-SBD—F05-1BBB. For more information go to diinmedmlmmihgev.
`
`Telt your healthcare provider if you are pregnant or pian to become preg na nt, or breastfeeding or plan to breastfeed. It is not
`known if TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also teil your healthcare provider if you are
`taking prescription or over-the—counter medicines. vitamins, or herbal supplements. If you take too much TECFIDERA, call
`your healthcare provider or go to the nearest hospital emergency room right away.
`
`EMPORTANT SAFETY INFORMATION AND INDICATiON
`
`COLLAPSE
`
`[MPORTANT SAFETY INFORMATION
`
`Do not use Tecfidera® [dimethyl fumaratei if you have had an allergic reaction [such as welts, hives, swelling of the face. lips. mouth or
`tongue. or difficulty breathing? to TECFIDERA or any of its ingredients. Read More
`
`Before taking and while you take i'ECPiDERA. tetl your healthcare provider about any low white blood celi counts or infections or any
`other medical conditions.
`
`IMPORTANT SAFETY ENFORMATION AND ENDICATION
`
`COLLAPSE
`
`IMPORTANT SAFETY INFORMATION
`
`htlps:llwww.tecfidera.oomlen_usli'tomeladditionaI-supportibiogen~patient-support.htmi
`
`2I3
`
`MYLAN PHARMS. INC. EXHIBIT 1072 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1072 PAGE 2
`
`

`

`7131I2019
`
`Biogen Patient Support Program |Tecfidera® (dimethyl fumarate)
`
`Do not use Tecfidera® [dimethyl fumaratel if you have had an allergic reaction isuch as wells. hives. swelling of the face. lips. moeth or
`tongue, or difficulty breathing] to TECFIDERA or any of its ingredients.
`
`Before taking and while you take TECFIDERA. tell your heatthcare provider about any low white blood cell counts or infections or any
`other medical conditions.
`
`What are the possible side effects of TECFIDERA?
`
`TECFIDERA may cause serious side effects including:
`a Allergic reactions
`
`a PML. which is a rare brain infection that usually leads to death or severe disability.
`
`9 Decreases in your white blood cell count. Your healthca re provider should check your white blood cell count before you take
`TECFIDERA and from time to time during treatment
`
`e Liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking TECFIDERA and
`during treatment if needed. Tell your heatthcare provider right away if you get any symptoms of a liver problem during treatment.
`including:
`
`0 severe tiredness
`
`0
`
`loss of appetite
`
`0 pain on the right side of your stomach
`0 dark or brown [tea coiori urine
`
`0 yellowing ofyour skin or the white part of your eyes
`
`The most common side effects of TECFIDERA include flushing and stomach problems. These can happen especially at the start of
`treatment and may decrease overtime. Taking TECFIDERA with food may help reduce flushing. Call your healthcare provider if these
`symptoms bother you or do not go away. Ask your healthcare provider if taking aspirin before taking TECFIDERA may reduce flushing.
`
`These are not all the possible side effects of TECFIDERA. Call your healthcare provider for medfcal advice about side effects. You may
`report side effects to FDA at 1-§fl|}—FDA-1888. For more information go to dialmgdmlmmihgg.
`
`Tell your healthcare provider if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if
`TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also tell your healthcare provider if you are taking
`prescription or over—the-counter medicines. vitamins. or herbal supplements. If you take too much TECFIDERA, call your healthcare
`provider or go to the nearest hospital emergency room right away.
`
`Please see foil Prescribing Information and Patient Information.
`
`This is not intended to replace discussions with your healthcare provider.
`Indication
`
`TECFIBERA is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.
`
`a .
`Brogen
`
`iMPORTANT SAFETY INFORMATION AND INDICATION
`
`IMPORTANT SAFETY INFORMATEON
`
`COLLAPSE
`
`Do not use Tecfidera® [dimethyl fumarate] if you have had an allergic reaction [such as wells. hives, swelling of the face. lips, mouth or
`tongue. or difficulty breathing] to TECFIDERA or any of its ingredients. Read More
`
`Before taking and while you take TECFIDERA, tell your healthcare provider about any low white blood cell counts or infections or any
`other medical conditions.
`
`IMPORTANT SAFETY INFORMATION AND INDECATION
`
`IMPORTANT SAFETY INFORMATION
`
`COLLAPSE
`
`https:llwww.tecfidera.comlen_uslhomefadditionaI-supportlbiogen-patient—support.html
`
`3/3
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`MYLAN PHARMS. INC. EXHIBIT 1072 PAGE 3
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`MYLAN PHARMS. INC. EXHIBIT 1072 PAGE 3
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