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PATIENT PACKAGE INSERT
Tyvaso (Tī-vāsō)
(treprostinil)
Inhalation Solution
Read this Patient Package Insert before you start taking Tyvaso and each time you get a refil . There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is Tyvaso?
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH),
which is high blood pressure in the arteries of your lungs. Tyvaso can improve the ability to do exercise in people who also take bosentan (an endothelin receptor antagonist (ERA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). Your ability to do exercise decreases 4 hours after taking Tyvaso.
It is not known if Tyvaso is safe or effective in people under 18 years of age.
What should I tell my healthcare provider before taking Tyvaso?
Before taking Tyvaso, tel your healthcare provider about all of your medical conditions,
• have lung disease, such as asthma or chronic obstructive pulmonary disease (COPD) • have liver problems or kidney problems • are pregnant or plan to become pregnant. It is not known if Tyvaso wil harm your unborn baby. Women who can become pregnant should use effective birth control while • are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while Tell your healthcare provider about all the medicines you take, including prescription
and non-prescription medicines, vitamins, and herbal supplements. Tyvaso and other medicines may affect each other. Especial y tel your healthcare provider if you take any of these medicines: • medicines that decrease blood clotting • medicines used to treat high blood pressure or heart disease • gemfibrozil (Lopid) (for high cholesterol) • rifampin (Rimactane, Rifadin, Rifamate, Rifater) (for infection) Know the medicines you take. Keep a list of them and show it to your healthcare provider and specialty pharmacist when you get a new medicine.
How should I take Tyvaso?
• Take Tyvaso each day exactly as your healthcare provider tel s you. • See the detailed Tyvaso Inhalation System Instructions for Use. • Tyvaso is breathed in (inhaled) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System. • Tyvaso is taken in 4 treatment sessions each day during waking hours. The sessions • At the beginning of each day, it wil take about 5 minutes to prepare the Tyvaso Inhalation System. Each treatment session will take 2 to 3 minutes. • Take your first Tyvaso treatment session in the morning and take your last treatment • Your healthcare provider may change your dose if needed. • If you miss a dose of Tyvaso take it as soon as you remember. • Do not let Tyvaso solution get into your eyes or onto your skin. If it does, rinse your skin • Using the Treatment Tracker, record the number of breaths you inhale during each treatment session (4 times a day). You should bring your Treatment Tracker to your medical appointments, as your doctor may want to review it with you. What are the possible side effects of Tyvaso?
Tyvaso can cause serious side effects, including:
• Tyvaso may increase the risk of bleeding in people who take blood thinners • If you have low blood pressure, Tyvaso may lower your blood pressure further. Ask your healthcare provider if you are not sure if this applies to you. The most common side effects of Tyvaso include: • reddening of your face and neck (flushing) Tel your healthcare provider if you have any side effect that bothers you or that does not go away. These are not al the possible side effects of Tyvaso. For more information, ask your healthcare provider or specialty pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects How should I store Tyvaso?
• Store Tyvaso ampules in the unopened foil pack between 59°F to 86°F (15°C to 30°C) • When the foil pouch is opened, Tyvaso ampules should be used within 7 days. • Tyvaso is sensitive to light. The unopened Tyvaso ampules should be stored in the foil • After a Tyvaso ampule is opened and put into the medicine cup in the Tyvaso Inhalation System, Tyvaso can be kept in the medicine cup for no more than 1 day (24 hours). • Tyvaso that is left in the medicine cup at the end of the day must be thrown away. • The Tyvaso Inhalation System can be stored in the carrying case when not in use (Example: between treatment sessions or overnight). If storing between treatment sessions, ensure that the plugs are firmly in place in the dome assembly to prevent spil age of Tyvaso. See the Instructions for Use for additional information regarding storage of your Tyvaso Inhalation System.
Keep Tyvaso and all medicines out of the reach of children.

General information about the safe and effective use of Tyvaso.
Medicines are sometimes prescribed for conditions that are not mentioned in a patient
information leaflet. Do not use Tyvaso for a condition for which it was not prescribed. Do not give Tyvaso to other people, even if they have the same symptoms you have. It may harm them. This patient information leaflet summarizes the most important information about Tyvaso. You can ask your healthcare provider or specialty pharmacist for information about Tyvaso that is written for health professionals. For more information, go to www.tyvaso.com or cal 1-877-UNITHER (1-877-864-8437). What are the ingredients in Tyvaso?
Inactive ingredients: sodium chloride, sodium citrate, sodium hydroxide, hydrochloric acid, and Tyvaso is a registered trademark of United Therapeutics Corporation. Literature issued May 2013. United Therapeutics Corp.
Research Triangle Park, NC 27709 USA
Copyright 2013, United Therapeutics Corp. Al rights reserved.

Source: http://tyvaso.com/content/docs/2013-05-08-PPI-Patient-Package-Insert.pdf