FREQUENTLY ASKED QUESTIONS

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

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

In the clinical trial, the most common adverse events were cough, headache, and throat irritation.²

Discontinuation rates due to an AE were similar for TYVASO and placebo at 9.8% and 8.0%, respectively.³

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

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

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

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

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

The TYVASO nebulizer 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.⁴

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 nebulizer, refer to the Cleaning and Storing section beginning on page 46 of the TYVASO Nebulizer Instructions for Use manual.⁴

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.

Titration with the TYVASO nebulizer^1,3:

TYVASO DPI provides your patients with the benefits of TYVASO in a convenient delivery device, which is a simple-to-use option for the treatment of PH-ILD.^5,6

TYVASO DPI efficiently leverages a low flow rate to deliver medication evenly.^7,8

A strong breath is not required to deliver a consistent dose to the distal airways.⁸

• Powder dispersion occurs early in the onset of inhalation, helping to deliver the powder to the site of disease⁸

TYVASO DPI was approved by the FDA via the 505(b)(1) pathway based on the results of the BREEZE study, in addition to prior clinical trials with TYVASO—including INCREASE.

• The safety and tolerability of switching from TYVASO to TYVASO DPI was assessed in the BREEZE study, an open-label clinical study of 51 patients with PAH. It was found that systemic exposure was similar between TYVASO and TYVASO DPI.^3,6 The BREEZE study only included patients with PAH; the FDA did not require TYVASO DPI to be studied in patients with PH-ILD
• The INCREASE trial was a 16-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study of 326 patients with PH-ILD designed to assess the efficacy and safety of TYVASO^1,2

TYVASO has been approved by the FDA for use in patients with PAH (WHO Group 1) and PH-ILD (WHO Group 3).¹

Titration with TYVASO DPI⁵:

Titration schedules may vary based on tolerability. If the prescribed dose is higher than 64 mcg per treatment session, more than 1 cartridge will be needed per session.⁵

TYVASO Nebulizer

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 Nebulizer 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 2 TYVASO nebulizers (NDC 66302-206-01).¹

The TYVASO Nebulizer 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 Nebulizer 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 2 TYVASO nebulizers (NDC 66302-206-04).¹

TYVASO DPI

Whether patients are starting, switching, or maintaining their treatment with TYVASO DPI, United Therapeutics offers 3 kits with multiple configurations to help.

TYVASO Nebulizer

Ampules of TYVASO are stable until the date indicated when stored in the unopened foil pouch at 20°C to 25°C (68°F to 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 nebulizer. 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

TYVASO DPI

Blister cards and strips:

Store at room temperature, 59°F to 86°F (15°C to 30°C). When at room temperature, sealed and unopened blister cards and strips must be used within 8 weeks, and opened strips must be used within 3 days.⁵

Additional blister cards and strips may be stored in the refrigerator, 36°F and 46°F (2°C and 8°C), until the expiration date printed on the blisters, but should be room temperature for 10 minutes before use.⁵

Do not put a blister card or strip back into the refrigerator after being opened or stored at room temperature.⁵

Inhaler:

The TYVASO DPI inhaler may be stored at room temperature or in the refrigerator, 36°F and 77°F (2°C and 25°C). If refrigerated, the inhaler should be left at room temperature for 10 minutes before use.⁵

The inhaler can be used for up to 7 days from the date of first use. After 7 days of use, the inhaler must be discarded and replaced with a new inhaler.⁵

TYVASO DPI and the TYVASO nebulizer are distributed by the following Specialty Pharmacies:

TYVASO can be prescribed by filling out the Referral Form.

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.

An RNS is available as an educational resource to help your care team understand considerations in treating patients with TYVASO. To request a Regional Nurse Specialist, click here.