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Tyvaso (Treprostinil) - Summary



Tyvaso is a sterile formulation of treprostinil intended for administration by oral inhalation using the Tyvaso Inhalation System.

Tyvaso is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately 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 controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration [see Clinical Studies].

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Published Studies Related to Tyvaso (Treprostinil)

Cutaneous iontophoresis of treprostinil in systemic sclerosis: a proof-of-concept study. [2014]
Ischemic digital ulcer (DU) is a serious complication of systemic sclerosis (SSc)...

Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. [2014]
trepostinil-induced pain... CONCLUSIONS: Further investigation of the efficacy of capsaicin 8% patch in this

Pharmacokinetics of oral treprostinil sustained release tablets during chronic administration to patients with pulmonary arterial hypertension. [2013]
Pulmonary arterial hypertension (PAH) is a progressive vascular disease that ultimately leads to right ventricular failure and death. Treprostinil diolamine is an oral prostacyclin analogue; sustained release tablets of oral treprostinil are currently being evaluated for efficacy and safety as a potential therapy in patients with PAH...

Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. [2011]
patients concurrently receiving oral background therapy... CONCLUSIONS: Long-term therapy with inhaled treprostinil demonstrated persistent

Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. [2010]
PAH-specific oral therapies... CONCLUSIONS: This trial demonstrates that, among PAH patients who remain

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Clinical Trials Related to Tyvaso (Treprostinil)

Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso´┐Ż Compared to Other FDA Approved PAH Therapies [Completed]
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso«(treprostinil) Inhalation Solution versus other FDA approved therapies

Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years [Recruiting]
This is a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who are, (1) transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin therapy; or (3) not currently receiving prostacyclin therapy.

Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation [Recruiting]
The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of a two-day peri-operative course of Treprostinil in liver transplant patients. The hypothesis of this study is that Treprostinil can be safely administered perioperatively in liver transplant patients. Once safety is documented future studies will address its ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and thereby reduce morbidity, leading to shorter hospital stays as compared to historical controls.

Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH [Terminated]
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.

Pulmonary Rehab in COPD: Response to Tyvaso [Not yet recruiting]
The investigators' hypothesis is that pretreating patients with COPD with inhaled treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise tolerance during sessions. This in turn will lead to an increased response to pulmonary rehabilitation, resulting in improved exercise tolerance and quality of life.

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Reports of Suspected Tyvaso (Treprostinil) Side Effects

Dyspnoea (148)Death (133)Pneumonia (83)Pulmonary Arterial Hypertension (68)Cardiac Failure Congestive (55)Fluid Retention (51)Syncope (50)Pulmonary Hypertension (45)Chest Pain (40)Dizziness (36)more >>

Page last updated: 2014-11-30

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