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`IMPORTANT SAFETY INFORMATION | PRESCRIBING INFORMATION ] PATIENT PACKAGE INSERT | lNSTRUCTIONS FOR USE I FOR HEALTHCARE PROFESSIONALS
`
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`JOIN THE TYVASO ( support Program )
`
`For the treatment of pulmonary arterial
`hypertension (WHO Group 1'}. Tyvaso can
`improve the ability to exercise in people who
`also take bosentan (an ERA) or sildenafil
`(a PDE—S inhibitor}
`
`0 Just Prescribed Tyvaso
`
`Your doctor has prescribed Tyvaso to help treat your pulmonary arterial hypertension (PAH). Now
`you may be wondering what comes next. Your doctor has put in a referral. or application. for your
`Tyvaso prescription. To ensure you get the help and support you need. Specialty Pharmacy
`Services (SPS) will be responsible for working with your insurance company or provider to process
`the referral.
`
`What is a Specialty Pharmacy Services provider?
`
`them overcome some of
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`their fears and previdmg a
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`Mentors
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`The Tyvaso Inhalation System is available only through the following SPS providers:
`
` "I really enjoy helping
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`little comfort " — D_T__, Tyvaso Mentor
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`Specialty Pharmacy Services (SP8) providers are different from the local pharmacy you normally
`visit. They will work with you and your healthcare team to coordinate many aspects of your care.
`This includes step~by—step training on how to use Tyvaso. and delivery of your prescription and
`supplies. This service is designed to provide you with ongoing support. Through your SPS provider,
`you can expect phone calls, automatic refills, and access to a 24-hour hotline.
`
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`FAX: 1-300-711-3526
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`Here is what you can expect while you wait for treatment to begin:
`
`REFERRAL—Your doctor has put in an application‘ or referral, for
`your Tyvaso prescription with an SPS provider, Your SPS provider
`9 will be your one-stop resource for support with Tyvaso. They will work
`with you and your healthcare team to coordinate many aspects of
`your care.
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`@fiOOO
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`INSURANCE—The SPS will be responsible for working with your
`insurance company to process the application or referral.
`
`CONFIRHA‘HON—Your insurance company may require
`confirmation that you have PAH. This may include a documentation
`of procedures, such as aW (RHC), which is
`necessary to confirm your PAH diagnosis and to access Tyvaso.
`
`DEMONSTRATION—Prior to your initial start date, your SPS nurse
`may contact you to schedule an appointment at your doctor's office or
`home to teach you how to use Tyvaso.
`
`APPROVAL—The SPS will notify you of your insurance company's
`approval and discuss any uncovered costs.
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`START TREATMENT—Your healthcare or SPS provider will contact
`you to coordinate the date and location for you to start using Tyvaso
`—do not start treatment with Tyvaso until you have completed your
`training and be sure to talk to your healthcare or SPS provider if you
`have any questions.
`
`Note: This is a general overview of the SP8 process and may vary based on individual
`circumstances or need.
`
`Next: Get Important Information If You’re Just Starting Tyvaso
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`IMPORTANT SAFETY INFORMATION FOR TWASO
`
`I Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System.
`
`Before you take Tyvaso, tell your healthcare provider about all of your medical conditionsI including if you:
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`I Have a lung disease (such as asthma or chronic obstructive pulmonary disease (COPD)).
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`I Have a lung infection.
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`I Have liver or kidney problems, as your ability to tolerate Tyvaso may be affected.
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`I Have low blood pressure, as Tyvaso may cause symptomatic hypotension (low blood pressure).
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`I Are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby. Women who can become pregnant
`should use effective birth control while taking Tyvaso.
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`I Are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk.
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`It is important to tell your healthcare provider about all the medicines you may be taking. including prescription and non-prescription
`medicines, vitamins, and herbal supplements. as they may affect your use of Tyvaso by increasing the risk of side effects or decreasing
`effectiveness. Especially tell your healthcare provider if you take any of these medicines:
`
`I Medicines that decrease blood clotting such as warfarin or heparin. as Tyvaso reduces the ability of your blood to clot (coagulate), and
`increases your risk for bleeding if you are taking blood thinners (anticoagulants).
`
`I Diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators
`{medications that lower blood pressure), as Tyvaso may increase your risk for hypotension (low blood pressure).
`
`I Gemfibrozil such as Lopid (for high cholesterol} or rifampin such as Rimactane, Rifadin, Rifamate or Rifater (for infection), as your
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`UNITED THERAPEUTICS, EX. 2060
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017~01622
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`Tyvaso dosage may need adjustment.
`
`The most common side effects of Tyvaso are coughing. headache. throat irritation and pain. nausea. reddening of the face and neck
`(flushing). and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your healthcare provider about
`any side effects that bother you or do not go away. Your healthcare provider may be able to help you manage the side effects.
`
`INDICATION
`
`Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) {WHO Group 1), which is high blood
`pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor
`antagonist, {ERA)) or sildenafil (a phosphodiesterase-S (P DE-5) inhibitor). Your ability to do exercise decreases 4 hours after taking
`Tyvaso.
`
`The effects of Tyvaso are unknown in patients under 18 years of age.
`TYVISIdttr—JUN‘I 6
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`Please see the EulLELesctininanImnatien. Eatientflizkagunsett. and the Tyvaso Inhalation System Instmctienmutse
`manual-
`
`For additional information about Tyvaso, visitW or call 1-877-UNITHER {1-877-864— 8437).
`
`Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at
`W or call 1-800-FDA-1088.
`
`This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare
`professional for treatment advioe.
`
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`Tyvaso is a registered trademark of United Therapeutics Corporation. All other trademarks and registered trademarks
`are the property of their respective owners.
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`© 2016 United Therapeutics Corporation. All rights reserved. USITYWAUG15I'354b
`
`This site is intended for use by US residents only.
`
`UNITED THERAPEUTICS, EX. 2060
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017—01622
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