What Is Tyvaso?
Tyvaso^® is a prostanoid indicated for the treatment of PAH (WHO Group1) to improve exercise ability. For the full Tyvaso indication, see below.

How Was Tyvaso Studied?
Tyvaso was studied in TRIUMPH I, one of the largest trials of an add-on therapy in PAH (N=235).

TRIUMPH I was a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of an inhalable prostanoid (Tyvaso) and a single oral PAH agent (a PDE-5 inhibitor or an ETRA). The primary efficacy endpoint of the trial was the change in six-minute walk distance (6MWD) relative to baseline at 12 weeks.

What Are the Most Common Adverse Events?
The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%).

Can Tyvaso Be Used During Pregnancy?
Tyvaso^® should be used in pregnancy only if clearly needed. Caution should be exercised when Tyvaso is administered to nursing women.

Are There Any Data on the Long-term Safety of Tyvaso?
The safety of Tyvaso^® was studied in a long-term, open-label extension study in which 206 patients were dosed for a mean duration of 1 year. The adverse events during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo-controlled trial (TRIUMPH I).

Serious adverse events during the open-label portion of the study included pneumonia in 8 subjects. There were 3 serious episodes of hemoptysis (1 fatal) noted during the open-label experience.

What Is the Tyvaso Inhalation System?
The Tyvaso^® Inhalation System is a lightweight, portable, handheld device approved for the administration of Tyvaso.

How Heavy Is the Tyvaso Inhalation System?
The Tyvaso^® Inhalation System weighs around 12.8 ounces. It is patient-friendly, lightweight, and weighs about the same as a bottle of cleaning supplies.

How Long Does Each Treatment Session Take?
Each treatment session should take about 2 to 3 minutes, 4 times daily during waking hours.

How Do Patients Keep Track of Their Treatment Breaths?
The Patient Tool Kit includes a Tyvaso^® Treatment Tracker (written diary) to help patients keep track of their breaths during each treatment session.

How Long Does It Take to Set Up the Tyvaso Inhalation System?
Setting up the Tyvaso^® Inhalation System for use takes about 5 minutes and must be done once each day, prior to the day’s first treatment session.

How Is the Tyvaso Inhalation System Cleaned and Stored?
The Tyvaso^® Inhalation System requires once-daily cleaning with warm, mild, soapy water. Accessory parts should be washed by hand and allowed to air dry. The device base should not be immersed in water or placed in a dishwasher.

Once a week, use a clean cloth to wipe the interior of the device chamber.

For a more instructions on Cleaning and Maintenance of the Tyvaso Inhalation System, refer to pages 18, 19, 20 and 21 of the Instructions for Use Manual (Also available in Spanish).

How Do You Order and Replace the Accessories?
Replacement accessory parts are delivered monthly with each Tyvaso^® prescription refill, for patient convenience. Call your Specialty Pharmacy Service provider with any additional questions.

How Is Tyvaso Supplied?
Tyvaso^® is supplied in 2.9 mL clear LDPE (plastic) ampules packaged as 4 ampules in a foil pouch. Tyvaso is a clear colorless to slightly yellow solution containing 1.74 mg of treprostinil per ampule at a concentration of 0.6 mg/mL.

Ampules of Tyvaso are stable until the date indicated when stored in the unopened foil pouch at 25°C (77°F), with excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once the foil pack is opened, ampules should be used within 7 days. Because Tyvaso is light-sensitive, unopened ampules should be stored in the foil pouch.

One ampule of Tyvaso should be used each day in the Tyvaso Inhalation System. After a Tyvaso ampule is opened and transferred to the medicine cup, the solution should remain in the device for no more than 1 day (24 hours). Any remaining solution should be discarded at the end of the day.

The Tyvaso Inhalation System Starter Kit contains a 28 ampule carton of Tyvaso (the 7 foil pouches each containing four 2.9 mL ampules. Each ampule contains 1.74 mg treprostinil [0.6 mg per mL]) and the Tyvaso Inhalation System (NDC 66302-206-01).

How Are Tyvaso and the Tyvaso Inhalation System Distributed?
Tyvaso^® is distributed by the following Specialty Pharmacy Service providers:

Tyvaso can be prescribed by filling out the Patient Referral Form.

What Additional Support Does the Specialty Pharmacy Service Provider Offer Your Patients?
Specialty Pharmacy Service providers are run by PAH-trained and -experienced nurses, pharmacists, and customer support personnel who work in person and over the phone with patients to assess how they are handling their treatment with Tyvaso^® and to help with any side effects they may be experiencing. These specialists keep in regular touch with patients throughout the year. A Tyvaso prescription enrolls patients automatically.

Below is an example of what a patient might experience:

• Within 14 days after the prescription of Tyvaso is filled, the patient receives 2 at-home training sessions with a nurse. The nurse phones weekly over the first month to see how the patient is managing
• The nurse telephones the patient weekly over the first month to see how the patient is managing treatment with Tyvaso
• After patient has taken Tyvaso for 6 months, the Specialty Pharmacy Service provider contacts you to determine how your patients are doing and to consult with you on treatment goals for the next 6 months

Should your patients require more assistance than outlined above, the Specialty Pharmacy Service provider will arrange for additional home visits or phone calls to make sure that treatment with Tyvaso is proceeding smoothly.

What Patient Support Programs Are Available?
Living PAH was created by United Therapeutics Corporation to help patients cope with the day-to-day challenges presented by PAH. It is designed to help patients learn more about PAH and treatment options, while offering emotional support and a chance to talk with others who have PAH. The program provides:

• PAH education, news, and support
• Opportunities to talk with other PAH patients
• Personal help when patients feel overwhelmed by PAH or need to talk with someone who understands their disease

Learn more about Living PAH.