The power of prostacyclin delivered with ease The power of prostacyclin delivered with ease

The Power of Prostacyclyn Delivered with Ease

YUTREPIA™ (treprostinil) is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability1

Enhanced deep‑lung delivery powered by PRINT® Technology2

  • Uniform, free-flowing particles designed to enhance deep-lung delivery

Ease of use with a low‑effort device1-6,*

  • YUTREPIA's low resistance device requires minimal inspiratory effort, which may benefit a broader array of patients
  • Not position-dependent, which may reduce the risk of patient error, spillage, or wasted medication
  • Convenient, with no refrigeration required

Titration to higher therapeutic doses1,2,7‑9

  • In the INSPIRE clinical trial, patients with PAH who were naive to prostacyclin therapy reached a mean YUTREPIA dose above 79.5mcg by month 2
  • Overall, 32.5% (n=26/80) of patients with PAH in INSPIRE reached a YUTREPIA dose of ≥159 mcg (equivalent to ≥18 breaths of inhaled treprostinil solution) at 2 years

Check back soon for more information on YUTREPIA.

Defined as low inspiratory effort.4,5

WHO = World Health Organization

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
YUTREPIA is a prostacyclin mimetic indicated for the treatment of:
  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies 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%).
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study 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%).
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with treprostinil may produce symptomatic hypotension.
  • Treprostinil inhibits platelet aggregation and increases 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, YUTREPIA 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 YUTREPIA.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

  • The concomitant use of treprostinil 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.
  • Placebo-controlled clinical studies of treprostinil inhalation solution did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. The open label INSPIRE study in patients with PAH included 28 patients aged 65 and over in which no age-related differences were noted. 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.
  • Uptitrate slowly when treating patients with hepatic insufficiency because of the risk of an increase in systemic exposure which may lead to an increase in dose-dependent adverse effects. Treprostinil has not been studied in patients with severe hepatic insufficiency.
  • No dose adjustments are required in patients with renal impairment. Treprostinil is not cleared by dialysis.

ADVERSE REACTIONS

  • The most commonly reported adverse reactions included cough, headache, throat irritation, dizziness, which are known side effects of treprostinil inhalation solution. The adverse reactions in the INSPIRE study were consistent with those observed in previous studies of inhaled treprostinil.
  • Adverse reactions with inhaled treprostinil were similar to the experience in studies of PAH.

Please see Full Prescribing Information for YUTREPIA.

 
INDICATION
YUTREPIA is a prostacyclin mimetic indicated for the treatment of:
  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies 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%).
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study 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%).
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with treprostinil may produce symptomatic hypotension.
  • Treprostinil inhibits platelet aggregation and increases 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, YUTREPIA 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 YUTREPIA.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

  • The concomitant use of treprostinil 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.
  • Placebo-controlled clinical studies of treprostinil inhalation solution did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. The open label INSPIRE study in patients with PAH included 28 patients aged 65 and over in which no age-related differences were noted. 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.
  • Uptitrate slowly when treating patients with hepatic insufficiency because of the risk of an increase in systemic exposure which may lead to an increase in dose-dependent adverse effects. Treprostinil has not been studied in patients with severe hepatic insufficiency.
  • No dose adjustments are required in patients with renal impairment. Treprostinil is not cleared by dialysis.

ADVERSE REACTIONS

  • The most commonly reported adverse reactions included cough, headache, throat irritation, dizziness, which are known side effects of treprostinil inhalation solution. The adverse reactions in the INSPIRE study were consistent with those observed in previous studies of inhaled treprostinil.
  • Adverse reactions with inhaled treprostinil were similar to the experience in studies of PAH.

Please see Full Prescribing Information for YUTREPIA.

References

  1. YUTREPIA. Prescribing information. Liquidia Technologies, Inc; 2025.
  2. Hill NS, Feldman JP, Sahay S, et al; INSPIRE study investigators. INSPIRE: safety and tolerability of inhaled Yutrepia (treprostinil) in pulmonary arterial hypertension (PAH). Pulm Circ. 2022;12(3):e12119. doi:10.1002/pul2.12119
  3. Patel S, Prabel J, MacLennan D, Rosen G. Robustness of YUTREPIA™, a dry-powder inhaled formulation of treprostinil, in patient misuse scenarios. Poster presented at: CHEST 2022 Annual Meeting; October 16 19, 2022; Nashville, TN.
  4. Price D, Chrystyn H. Concept review of dry powder inhalers: correct interpretation of published data. Multidiscip Respir Med. 2015;10:36. doi:10.1186/s40248 015 0033 0
  5. National Health Service Sunderland. Sunderland COPD Inhaler Guide. National Health Service; 2020.
  6. Berkenfeld K, Lamprecht A, McConville JT. Devices for dry powder drug delivery to the lung. AAPS PharmSciTech. 2015;16(3):479 490. doi:10.1208/s12249 015 0317 x
  7. Simon MA, Shapiro SM, Sahay S, et al. Clinical outcomes of YUTREPIA™ dose in 6MWD and quality of life. Poster presented at: CHEST 2022 Annual Meeting; October 16 19, 2022; Nashville, TN.
  8. Nathan SD, Deng C, King CS, et al. Inhaled treprostinil dosage in pulmonary hypertension associated with interstitial lung disease and its effects on clinical outcomes. Chest. 2023;163(2):398 406. doi:10.1016/j.chest.2022.09.007
  9. Data on file. Liquidia Technologies, Inc