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Tyvaso
(Ti-vaso)
(treprostinil) Inhalation Solution

Read this Patient Package Insert before you start taking Tyvaso (treprostinil inhalation solution) and each time you get a refill. 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 (treprostinil inhalation solution) ?

Tyvaso (treprostinil inhalation solution) 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 (treprostinil inhalation solution) 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 (treprostinil inhalation solution) .

It is not known if Tyvaso (treprostinil inhalation solution) is safe or effective in people under 18 years of age.

What should I tell my healthcare provider before taking Tyvaso (treprostinil inhalation solution) ?

Before taking Tyvaso (treprostinil inhalation solution) , tell your healthcare provider about all of your medical conditions, including if you:

• have lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
• have a lung infection
• have liver problems or kidney problems
• have low blood pressure
• are pregnant or plan to become pregnant. It is not known if Tyvaso (treprostinil inhalation solution) will harm your unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso (treprostinil inhalation solution) .
• are breast-feeding or plan to breast-feed. It is not known if Tyvaso (treprostinil inhalation solution) passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Tyvaso (treprostinil inhalation solution) .

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tyvaso (treprostinil inhalation solution) and other medicines may affect each other.

Especially tell your healthcare provider if you take any of these medicines:

• medicines that decrease blood clotting
• water pills (diuretics)
• 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 (treprostinil inhalation solution) ?

• Take Tyvaso (treprostinil inhalation solution) each day exactly as your healthcare provider tells you.
• See the detailed Tyvaso (treprostinil inhalation solution) Inhalation System Instructions for Use.
• Tyvaso (treprostinil inhalation solution) is breathed in (inhaled) through your mouth into your lungs. Tyvaso (treprostinil inhalation solution) should only be used with the Tyvaso (treprostinil inhalation solution) Inhalation System.
• Tyvaso (treprostinil inhalation solution) is taken in 4 treatment sessions each day during waking hours. The sessions should be at about 4 hours apart.
• At the beginning of each day, it will take about 5 minutes to prepare the Tyvaso (treprostinil inhalation solution) Inhalation System. Each treatment session will take 2 to 3 minutes.
• Take your first Tyvaso (treprostinil inhalation solution) treatment session in the morning and take your last treatment session before bedtime.
• Your healthcare provider may change your dose if needed.
• If you miss a dose of Tyvaso (treprostinil inhalation solution) take it as soon as you remember.
• Do not let Tyvaso (treprostinil inhalation solution) solution get into your eyes or onto your skin. If it does, rinse your skin or eyes right away with water.

What are the possible side effects of Tyvaso (treprostinil inhalation solution) ?

Tyvaso (treprostinil inhalation solution) can cause serious side effects, including:

• Tyvaso (treprostinil inhalation solution) may increase the risk of bleeding in people who take blood thinners (anticoagulants).
• If you have low blood pressure, Tyvaso (treprostinil inhalation solution) 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 (treprostinil inhalation solution) include:

• coughing
• headache
• nausea
• reddening of your face and neck (flushing)
• throat irritation and pain
• fainting or loss of consciousness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tyvaso (treprostinil inhalation solution) . 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 to FDA at 1-800-FDA-1088.

How should I store Tyvaso (treprostinil inhalation solution) ?

• Store Tyvaso (treprostinil inhalation solution) ampules in the unopened foil pack between 59°F to 86°F (15°C to 30°C) until ready to use.
• When the foil pouch is opened, Tyvaso (treprostinil inhalation solution) ampules should be used within 7 days.
• Tyvaso (treprostinil inhalation solution) is sensitive to light. The unopened Tyvaso (treprostinil inhalation solution) ampules should be stored in the foil pouch.
• After a Tyvaso (treprostinil inhalation solution) ampule is opened and put into the medicine cup in the Tyvaso (treprostinil inhalation solution) Inhalation System, Tyvaso (treprostinil inhalation solution) can be kept in the medicine cup for no more than 1 day (24 hours).
• Tyvaso (treprostinil inhalation solution) that is left in the medicine cup at the end of the day must be thrown away.

Keep Tyvaso (treprostinil inhalation solution) and all medicines out of the reach of children.

General information about the safe and effective use of Tyvaso (treprostinil inhalation solution)

Medicines are sometimes prescribed for conditions that are not mentioned in a patient information leaflet. Do not use Tyvaso (treprostinil inhalation solution) for a condition for which it was not prescribed. Do not give Tyvaso (treprostinil inhalation solution) 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 (treprostinil inhalation solution) . You can ask your healthcare provider or specialty pharmacist for information about Tyvaso (treprostinil inhalation solution) that is written for health professionals.

For more information, go to www.tyvaso (treprostinil inhalation solution) .com or call 1-866-458-6479.

What are the ingredients in Tyvaso?

Active ingredient: treprostinil
Inactive ingredients: sodium chloride, sodium citrate, sodium hydroxide, hydrochloric acid, and water for injection.

Literature issued February 2011.

Last reviewed on RxList: 4/14/2011
This monograph has been modified to include the generic and brand name in many instances.