TYVASO 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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NEWS HIGHLIGHTS
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
Clinical Trials Related to Tyvaso (Treprostinil)
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso� 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.
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 >>
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