FDA approved Tyvaso (treprostinil) for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung DiseaseFDA approved new inhaled drug called Tyvaso for two serious lung conditions

FDA From the archive Source published July 30, 2009 Summary added April 14, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Tyvaso for PAH or PH-ILD to improve exercise ability, with dosing via inhalation system in four daily sessions.

The FDA has approved Tyvaso (treprostinil), an inhaled prostacyclin mimetic, for two indications: pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), both to improve exercise ability. This approval provides a new treatment option for patients with these conditions, addressing a clinical need for therapies that can enhance functional capacity. The PAH indication is supported by data from patients predominantly with NYHA Functional Class III symptoms, while the PH-ILD indication includes patients with etiologies such as idiopathic interstitial pneumonia and connective tissue disease. Tyvaso is administered via a specialized inhalation system in four daily treatment sessions, offering a route of administration that may be convenient for some patients. Clinicians should note that the controlled clinical experience for PAH was limited to 12 weeks and primarily on background therapy with bosentan or sildenafil, and the effects diminish over the dosing interval, allowing timing adjustments for planned activities.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Tyvaso is 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%). Tyvaso is also indicated for the treatment of 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%).

Dosing & Administration

Use only with the Tyvaso Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso delivers approximately 6 mcg of treprostinil. Administer in 4 separate treatment sessions each day approximately 4 hours apart, during waking hours. Initial dosage: 3 breaths (18 mcg) per treatment session. If 3 breaths are not tolerated, reduce to 1 or 2 breaths. Dosage should be increased by an additional 3 breaths per treatment session at approximately 1- to 2-week intervals, if tolerated. Titrate to target maintenance doses of 9 to 12 breaths per treatment session, 4 times daily. If adverse effects preclude titration to target dose, continue at the highest tolerated dose. If a scheduled treatment session is missed or interrupted, resume as soon as possible at the usual dose. Do not mix Tyvaso with other medications in the Tyvaso Inhalation System. Avoid skin or eye contact with Tyvaso solution. Do not orally ingest the Tyvaso solution.

Key Clinical Trial Data

For PAH, TRIUMPH I was a 12-week, randomized, double-blind, placebo-controlled, multicenter study of patients with PAH (WHO Group 1), nearly all with NYHA Class III (98%) symptoms who were receiving either bosentan or sildenafil for at least 3 months prior to study initiation. The controlled clinical experience was limited to 12 weeks in duration. For PH-ILD, trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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 effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

The U.S. Food and Drug Administration has approved a new medication called Tyvaso for two serious lung conditions. Tyvaso is an inhaled drug that treats two types of high blood pressure in the lungs: pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. These conditions make it hard for the heart to pump blood through the lungs, causing shortness of breath and limiting physical activity.

Tyvaso is specifically for adults with these conditions who need help improving their ability to exercise and do daily activities. The drug is taken using a specialized inhaler system four times a day. This approval means doctors now have another treatment option to offer patients who struggle with these challenging conditions.

It's important to understand that while this approval is good news, the clinical studies for pulmonary arterial hypertension lasted only 12 weeks and most patients were already taking other medications. The effects of Tyvaso wear off between doses, so timing of treatments can be adjusted around planned activities.

If you or someone you know has one of these conditions, the most important step is to have a conversation with your healthcare provider. They can explain whether Tyvaso might be appropriate based on your specific situation and medical history.

What this means for you:

New inhaled treatment option available for certain lung conditions, but talk to your doctor first.

Study Details

Study typeFda approval

PublishedJul 2009

View Original Abstract ↓

1 INDICATIONS AND USAGE Tyvaso 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%). ( 1.1 ) 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%). ( 1.2 ) 1.1 Pulmonary Arterial Hypertension Tyvaso is 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%). 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 (14) ] . 1.2 Pulmonary Hypertension Associated with ILD Tyvaso is indicated for the treatment of 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%) [see Clinical Studies (14) ] .

FDA approved Tyvaso (treprostinil) for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung DiseaseFDA approved new inhaled drug called Tyvaso for two serious lung conditions

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FDA approved Tyvaso (treprostinil) for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung DiseaseFDA approved new inhaled drug called Tyvaso for two serious lung conditions

Study Details

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