FREQUENTLY ASKED QUESTIONS

What is TYVASO®?

TYVASO is an inhaled prostacyclin mimetic indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.1

How was TYVASO studied?

TYVASO was studied in INCREASE—a 16-week phase 3, multicenter, randomized, double-blind, placebo-controlled study of 326 patients.1

What are the most common adverse events?

In the clinical trial, the most common adverse events were cough, headache, and throat irritation.1

Discontinuation rates due to an AE were similar for TYVASO and placebo at 9.8% and 8.0%, respectively.2

Can TYVASO be used during pregnancy?

There are no adequate and well-controlled studies with TYVASO in pregnant women. It is not known whether treprostinil is excreted in human milk.1

Are there any data on long-term treatment with TYVASO for PH-ILD?

There is an ongoing, long-term, open-label extension study. Check back for more information.

What is the TYVASO Inhalation System?

The TYVASO Inhalation System is a lightweight, portable, handheld nebulizer approved for direct-to-the-lungs administration of TYVASO.1

How long does each dosing session take?

Each treatment session should take about 2-3 minutes and should be administered 4x daily, approximately every 4 waking hours.1

How do patients keep track of their treatments?

The patient starter kit includes a TYVASO Treatment Tracker (written diary) to help patients keep track of their breaths during each treatment session. A new treatment tracker is provided monthly with each TYVASO prescription refill.

How is the TYVASO Inhalation System cleaned?

The TYVASO Inhalation System requires once-daily cleaning with warm, soapy water. Accessory parts should be washed by hand and allowed to air-dry. The base of the device should not be immersed in water or placed in a dishwasher.3

Once a week, use a clean cloth to wipe the interior of the device chamber. For more instructions on cleaning and maintenance of the TYVASO Inhalation System, refer to the Cleaning and Storing section beginning on page 46 of the Instructions for Use manual.3

How do you order and replace the accessories?

For patient convenience, replacement accessory parts are delivered monthly with each TYVASO prescription refill. Call your Specialty Pharmacy provider with any additional questions. Patients will receive a replacement device every 2 years.

How is TYVASO supplied?

TYVASO is supplied in 2.9-mL, clear, low-density polyethylene (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.1

The TYVASO Inhalation System Starter Kit contains a 28-ampule carton of TYVASO (the 7 foil pouches each contain 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).1

The TYVASO Inhalation System Refill Kit contains a 28-ampule carton of TYVASO (the 7 foil pouches each contain four 2.9-mL ampules; each ampule contains 1.74 mg treprostinil [0.6 mg per mL]) and accessories (NDC 66302-206-02).1

The TYVASO 4-Pack Carton with 1 foil pouch contains four 2.9-mL ampules; each ampule contains 1.74 mg treprostinil (0.6 mg per mL) (NDC 66302-206-03).1

The TYVASO Inhalation System Institutional Starter Kit contains a 4-ampule carton of TYVASO (1 foil pouch contains four 2.9-mL ampules; each ampule contains 1.74 mg treprostinil [0.6 mg per mL]) and the TYVASO Inhalation System (NDC 66302-206-04).1

How is TYVASO stored?

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°C to 30°C (59°F to 86°F). 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.1

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.1

How are TYVASO and the TYVASO Inhalation System distributed?

TYVASO is distributed by the following Specialty Pharmacies:

ACCREDO®
Phone: 1-866-344-4874
Fax: 1-800-711-3526
www.accredo.com

CVS CAREMARK SPECIALTY RX™
Phone: 1-877-242-2738
Fax: 1-877-943-1000
www.cvsspecialty.com

TYVASO can be prescribed by filling out the Referral Form.

How can patients get in contact with a United Therapeutics Virtual Patient Educator?

Patients must enroll in the Archways program to participate. In order to enroll in the Archways program, patients must have a diagnosis of PH-ILD as well as a prescription for TYVASO. To get started and learn more about how the UT Virtual Patient Educators can help, patients can:

United Therapeutics and the Archways program do not provide medical advice. Patients are advised to consult with their HCP with any specific questions or concerns about their treatment.

What additional support does the Specialty Pharmacy provider offer your patients?

The Specialty Pharmacy providers are available to help initiate TYVASO therapy and provide continuous patient support with ongoing services and resources. Services offered to patients include one-step referral, reimbursement support, initial delivery of TYVASO and supplies, in-home device training, ongoing follow-up, and delivery of monthly refills.

AE=adverse event; NDC=National Drug Code; PH-ILD=pulmonary hypertension associated with interstitial lung disease; WHO=World Health Organization.