TYVASO DPI IS NOW APPROVED

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FOR US HEALTHCARE PROFESSIONALS ONLY

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

BENEFITS OF REACHING TARGET DOSE

Help your patients get the most out of TYVASO by achieving the target maintenance dose1

6MWD

Patients receiving a higher dose of TYVASO achieved a 67% greater improvement in 6MWD at 16 weeks1

Patients receiving a higher dose of TYVASO achieved nearly double the improvement in 6MWD at 16 weeksPatients receiving a higher dose of TYVASO achieved nearly double the improvement in 6MWD at 16 weeks

Hodges-Lehmann placebo-corrected median difference.

In the MMRM analysis, patients achieving 10-12 breaths had nearly double the improvement in 6MWD at 16 weeks. Change in 6MWD by dose was a prespecified subgroup analysis.2

Clinical Worsening

Fewer patients in the higher-dose group experienced a clinical worsening event3

The clinical worsening data is a post hoc analysis of data from a prespecified efficacy endpoint.The clinical worsening data is a post hoc analysis of data from a prespecified efficacy endpoint.

Percentage of patients experiencing an event.

The clinical worsening data is a post hoc analysis of data from a prespecified efficacy endpoint. Interpret with appropriate caution.

Our TYVASO Nebulizer Treatment Tracker can help your patients stay on track with their treatment sessions.

Setting your patients up for success

1

Set realistic expectations

  • As the patient titrates to target maintenance dose, they may not see immediate clinical improvements4

Explain importance of reaching target maintenance dose to realize full benefits1

2

Prepare for common AEs

  • Review AEs (eg, cough, headache, and throat irritation) and why they may occur5
  • Give patients specific instructions to proactively manage any AEs that occur
  • Complete AE Management section on the Referral Form

Stress that they should not stop treatment without consulting you

See AE Management Approaches

3

Ensure patients understand the dosing plan

  • With the TYVASO nebulizer, target maintenance dose can be achieved by starting with 3 breaths per session at week 1 and increasing by 1 breath per week until reaching 9-12 breaths per session1,6
  • With TYVASO DPI, target maintenance dose can be achieved by starting with 16 mcg (1 cartridge) and increasing by 16 mcg at 1- to 2-week intervals to a target maintenance dose of 48 mcg to 64 mcg per treatment session7
  • Once the target maintenance dose is achieved, the patient should maintain that dose with each treatment session, as tolerated

Emphasize importance of completing all 4 daily treatment sessions

6MWD=6-minute walk distance; AE=adverse event; MMRM=mixed-effect model repeat measurement.

View AE management techniques

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

EXPAND

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. TYVASO [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2021. 2. Waxman A, Restrepo-Jaramillo R, Thenappan T, et al. Inhaled treprostinil in pulmonary hypertension due to interstitial lung disease. N Engl J Med. 2021;384(suppl):1-30. doi:10.1056/NEJMoa2008470. 3. Tapson VF, Nathan SD, Fisher M, et al. Dose-response analysis of inhaled treprostinil in pulmonary hypertension associated with interstitial lung disease and its effects on clinical worsening. Poster presented at CHEST 2021; October 17-20, 2021; Virtual. 4. Poms A, Kingman M. Inhaled treprostinil for the treatment of pulmonary arterial hypertension. Crit Care Nurse. 2011;31(6):e1-e10. 5. Waxman A, Restrepo-Jaramillo R, Thenappan T, et al. Inhaled Treprostinil in pulmonary hypertension due to interstitial lung disease. N Engl J Med. 2021;384(4):325-334. 6. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. 7. TYVASO DPI [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2022.

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