hand holding TYVASO DPI

TYVASO DPI
the proven efficacy of TYVASO
in the palm of your hand1,2

TYVASO DPI is a simple-to-use, inhaled prostacyclin therapy that delivers the trusted safety and benefits of TYVASO.1,2

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SIMPLE
TO USE

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SMALL AND
PORTABLE

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PROVEN
EFFICACY1,2

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HIGH
PATIENT
SATISFACTION2

TYVASO DPI is dosed with just 1 breath per cartridge, 4x daily, approximately every 4 waking hours. Each dose is inhaled in less than 2 seconds.1,3

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TYVASO DPI EFFICIENTLY LEVERAGES A LOW FLOW RATE TO DELIVER MEDICATION EVENLY.3,4


A STRONG BREATH IS NOT REQUIRED TO DELIVER A CONSISTENT DOSE TO THE DISTAL AIRWAYS.4

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The BREEZE study was designed to assess the safety and tolerability of switching from TYVASO to TYVASO DPI2

This open-label clinical study evaluated patients with PAH (N=51) who were on a stable dose of TYVASO and were switched to a corresponding dose of TYVASO DPI.2

In the BREEZE study, patients were evaluated throughout a 3 week Treatment Phase and had the opportunity to continue therapy in an optional extension phase (OEP) for a period of 51 weeks.

Patients underwent safety and pharmacokinetic assessments and 6-minute walk tests, and also completed questionnaires about device preference and satisfaction.2

49 of 51 patients (96%) elected to continue therapy with TYVASO DPI in an optional extension phase (OEP) with follow-up visits every 8 weeks.2

Select patient background information

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    Patients started TYVASO ≥3 months prior to the baseline visit and were on a stable regimen (no change in dose within 30 days of baseline visit) of TYVASO (6 to 12 breaths QID)2

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    80% of patients were on dual background therapy in addition to TYVASO2†

    If receiving other approved background therapy, the patient was required to be on a stable dose with no additions or discontinuations for a minimum of 30 days2

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    61% of patients were FC II at screening2‡

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    FC IV patients were excluded from the study5

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    Patients had a mean baseline 6MWD of 418.9 m (SD 109.4)2

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    Patients had a forced expiratory volume in 1 second (FEV1) ≥60% and forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio ≥60% during the 6 months prior to enrollment2

84.3% endothelin receptor antagonist, 80.4% phosphodiesterase type 5 inhibitor, and 13.7% soluble guanylate cyclase stimulator.2
12% were FC I and 27% were FC III.2

Results

Adverse reactions: Consistent safety and tolerability when switching to TYVASO DPI1

During the treatment phase of the BREEZE study, most commonly reported (≥4% of patients) AEs in patients previously stable on TYVASO were1,2:

  • Cough (35%)
  • Headache (16%)
  • Dyspnea (8%)
  • Nausea (6%)

Discontinuation of TYVASO DPI due to an AE occurred in 2 (3.9%) patients.2

Patient tolerability, as assessed by incidence of new adverse events following transition to TYVASO DPI, was consistent with the expected known safety profile of TYVASO.1

Systemic exposure was similar between TYVASO DPI and TYVASO2,6

Mean treprostinil concentration over time (dose levels pooled)6

Systemic exposure was similar between TYVASO DPI and TYVASO.

The maximum mean treprostinil concentration occurred rapidly for both TYVASO and TYVASO DPI in the low-, mid-, and high-dose groups: 32 mcg (6-7 breaths; n=2), 48 mcg (8-10 breaths; n=27), and 64 mcg (11-12 breaths; n=22).2,5

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11.5 m additional increase in 6MWD2

For patients previously stable on TYVASO, TYVASO DPI demonstrated a significant improvement in 6MWD at week 3 compared with TYVASO treatment at baseline. Interim results of the OEP suggest that this improvement was sustained over 51 weeks.2

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45/46 (P<0.0001)

REPORTED PATIENT SATISFACTION WITH TYVASO DPI

at week 3 compared with 31% (16/51) of patients satisfied with the TYVASO nebulizer at baseline.2

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TYVASO DPI inhaler and cartridges

Learn more about TYVASO for the treatment of PAH and PH-ILD and the support available to you and your patients.7

TYVASO for PAH

REQUEST A REP TYVASO (treprostinil) Inhalation Solution logo

TYVASO for
PH-ILD

REQUEST A REP TYVASO (treprostinil) Inhalation Solution logo

TYVASO DPI
THE PROVEN EFFICACY OF TYVASO® IN THE PALM OF YOUR HAND1,2

TYVASO DPI Inhalation Powder is a simple-to-use, inhaled prostacyclin therapy that delivers the trusted safety and benefits of TYVASO.1,2

Get the details about TYVASO DPI.

DPI=dry powder inhaler.

References: 1. TYVASO DPI [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2022. 2. Spikes LA, Bajwa AA, Burger CD, et al. BREEZE: open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI in patients with pulmonary arterial hypertension. Pulm Circ. 2022;12:e12063. doi:10.1002/pul2.12063.