TYVASO DPI IS NOW APPROVED

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For the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

FOR US HEALTHCARE PROFESSIONALS ONLY

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FOR US HEALTHCARE PROFESSIONALS ONLY
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SELECT INDICATION

ABOUT PH-ILD

WHAT IS TYVASO?

CLINICAL STUDIES

STARTING TYVASO

RESOURCES & SUPPORT

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

LEARN MORE

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.

LEARN ABOUT THE TYVASO DEVICE OPTIONS

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.

LEARN MORE

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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IMPORTANT SAFETY INFORMATION

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WARNINGS AND PRECAUTIONS

  • TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.

  • Both products inhibit platelet aggregation and increase the risk of bleeding.

INDICATION

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of:

  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with TYVASO establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).
  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with TYVASO establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration.

IMPORTANT SAFETY INFORMATION

COLLAPSE

WARNINGS AND PRECAUTIONS

  • TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.

  • Both products inhibit platelet aggregation and increase the risk of bleeding.
  • Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.
  • Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

  • The concomitant use of either product with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
  • Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
  • Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Safety and effectiveness in pediatric patients have not been established.
  • Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH‑ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

ADVERSE REACTIONS

  • Pulmonary Hypertension Associated with ILD (WHO Group 3)
    In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions with TYVASO were similar to the experience in studies of PAH.
  • Pulmonary Arterial Hypertension (WHO Group 1)
    In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo 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%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥4% of PAH patients during the 3-week treatment phase included cough (35.3%), headache (15.7%), dyspnea (7.8%), and nausea (5.9%).

Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.TYVASOhcp.com or call 1-877-UNITHER (1-877-864-8437).


TYVISIhcpMAY2022

References: 1. 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. 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(suppl):e12063. doi:10.1002/pul2.12063. 3. TYVASO DPI [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2022. 4. Data on file. United Therapeutics Corporation. Research Triangle Park, NC.

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