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Tyvaso (treprostinil)

Company: United Therapeutics
Approval Status: Approved July 2009
Treatment for: pulmonary arterial hypertension
Areas: Cardiovascular / Cardiology; Respiratory

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |

General Information

Tyvaso is a prostacyclin analogue. It directs vasodilation of pulmonary and systemic arterial vascular beds and inhibits platelet aggregation.

Tyvaso is specifically indicated to increase walk distance in patients with WHO Group I pulmonary arterial hypertension and NYHA Class III symptoms.

Tyvaso is suppled as a solution designed for oral inhalation. Tyvaso should be dosed in 4 separate, equally spaced treatment sessions per day, during waking hours. The treatment sessions should be approximately 4 hours apart.

Initial Dosage
Therapy should begin with 3 breaths of Tyvaso (18 mcg of treprostinil), per treatment session, 4 times daily. If 3 breaths are not tolerated, reduce to 1 or 2 breaths and subsequently increase to 3 breaths, as tolerated.

Maintenance Dosage
Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated, until the target dose of 9 breaths (54 mcg of treprostinil) is reached per treatment session, 4 times daily. If adverse effects preclude titration to target dose, Tyvaso should be continued at the highest tolerated dose. The maximum recommended dosage is 9 breaths per treatment session, 4 times daily.

Clinical Results

FDA Approval
The FDA approval of Tyvaso was based on the results of a 12-week, randomized, double-blind, placebo-controlled multi-center study, dubbed TRIUMPH. This trial enrolled 235 clinically stable subjects who were receiving either bosentan or sildenafil for at least three months prior to study initiation. The subjects received either placebo or Tyvaso in four daily treatment sessions with a target dose of 9 breaths (54 mcg) per session over the course of the 12-week study. The primary efficacy endpoint was the change in six-minute walk distance (6MWD) relative to baseline at 12 weeks. The subjects receiving Tyvaso had a placebo-corrected median change from baseline in peak 6MWD of 20 meters at Week 12 (p<0.001).

Side Effects

Adverse events associated with the use of Tyvaso may include, but are not limited to, the following:

  • Cough
  • Headache
  • Throat Irritation
  • Nausea
  • Flushing
  • Syncope

Mechanism of Action

Tyvaso is a prostacyclin analogue. It directs vasodilation of pulmonary and systemic arterial vascular beds and inhibits platelet aggregation.

Literature References

Voswinckel R, Reichenberger F, Gall H, Schmehl T, Gessler T, Schermuly RT, Grimminger F, Rubin LJ, Seeger W, Ghofrani HA, Olschewski HM Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension. Pulmonary pharmacology & therapeutics 2009 Feb;22(1):50-6. Epub 2008 Nov 30

Voswinckel R, Enke B, Reichenberger F, Kohstall M, Kreckel A, Krick S, Gall H, Gessler T, Schmehl T, Ghofrani HA, Schermuly RT, Grimminger F, Rubin LJ, Seeger W, Olschewski H Favorable effects of inhaled treprostinil in severe pulmonary hypertension: results from randomized controlled pilot studies. Journal of the American College of Cardiology 2006 Oct 17;48(8):1672-81

Additional Information

For additional information regarding Tyvaso or pulmonary arterial hypertension, please visit the Tyvaso web page.

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Tyvaso Drug Information

The Tyvaso drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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