TYVASO DPI IS NOW APPROVED

BREEZE STUDY

The BREEZE study was designed to assess the safety and tolerability of switching from TYVASO to TYVASO DPI1

BREEZE Study Design: 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.1

BREEZE Study baseline to 3 weeks before optional extension phase.

Patients underwent safety and pharmacokinetic assessments and 6-minute walk tests, and also completed questionnaires about device preference and satisfaction.1

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.1

Select patient background information

  • 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)1
  • 80% of patients were on dual background therapy in addition to TYVASO1*
    • 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 days1
  • 61% of patients were FC II at screening1†
  • FC IV patients were excluded from the study2
  • Patients had a mean baseline 6MWD of 418.9 m (SD 109.4)1
  • 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 enrollment1
*84.3% endothelin receptor antagonist, 80.4% phosphodiesterase type 5 inhibitor, and 13.7% soluble guanylate cyclase stimulator.1
12% were FC I and 27% were FC III.1

Results

Adverse reactions: Consistent safety and tolerability when switching to TYVASO DPI3

During the treatment phase of the BREEZE study, most commonly reported (≥4% of patients) AEs in patients previously stable on TYVASO were1,3:

Adverse Event
Percentage

Cough
35%

Headache
16%

Dyspnea
8%

Nausea
6%

Discontinuation of TYVASO DPI due to an AE occurred in 2 (3.9%) patients.1

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.3

Systemic exposure was similar between TYVASO DPI and TYVASO1,4

Mean treprostinil concentration over time (dose levels pooled)4

Mean treprostinil concentration over time showing systemic exposure was similar between TYVASO DPI and TYVASO in the BREEZE Study.
Mean treprostinil concentration over time showing systemic exposure was similar between TYVASO DPI and TYVASO in the BREEZE Study.

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).1,2

11.5 m additional increase in 6MWD1

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.1

Satisfaction with TYVASO DPI significantly improved when compared with TYVASO1

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 ultrasonic nebulizer at baseline.1

TYVASO DPI is a simple-to-use delivery option

6MWD=6-minute walk distance; AE=adverse event; DPI=dry powder inhaler; FC=functional class; PAH=pulmonary arterial hypertension; QID=4 times daily; SD=standard deviation.

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.

This referral form has recently been revised to include TYVASO DPI™ (treprostinil) Inhalation Powder, a new dry powder inhaler option for your patients.

Currently, the 48 mcg (112 ct) and 64 mcg (112 ct) Maintenance Kits (28-day supply) are available for ordering. These strengths correspond with 8-10 breaths and 11-12 breaths with the TYVASO nebulizer, respectively. The remaining Maintenance Kits and Titration Kits will be available soon.

To learn more about TYVASO DPI and Kit availability, please reach out to your local United Therapeutics Cardiopulmonary Specialist.

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