Generic Name and Formulations:
Treprostinil 0.6mg/mL; soln for oral inhalation using Tyvaso Inhalation System.

Company:
United Therapeutics Corp
Indications for TYVASO:
Pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to improve exercise ability.

Adult:
Give 4 separate treatment sessions each day approximately 4hrs apart, during waking hours. ≥18yrs: Initially 3 breaths (18mcg) per treatment session; if not tolerated, reduce to 1–2 breaths, and then subsequently increase to 3 breaths as tolerated. Maintenance: may increase by an additional 3 breaths at 1–2 week intervals, if tolerated, to target dose of 9 breaths (54mcg) per treatment session.

Children:
<18yrs: not established.

Warnings/Precautions:
Significant underlying lung disease (eg, asthma, COPD). Acute pulmonary infections. Patients with low systemic arterial pressure. Hepatic or renal insufficiency. Bleeding disorders. Avoid contact with eyes and skin, oral ingestion. Elderly. Labor & delivery. Pregnancy (Cat.B). Nursing mothers.

Interactions:
Increased risk of symptomatic hypotension with concomitant diuretics, antihypertensives, other vasodilators. May be potentiated by CYP2C8 inhibitor (eg, gemfibrozil). May be antagonized by CYP2C8 inducer (eg, rifampin). Increased risk of bleeding with anticoagulants.

Pharmacological Class:
Prostacyclin analogue.

Adverse Reactions:
Cough, headache, nausea, diarrhea, dizziness, flushing, throat irritation, pharyngolaryngeal pain; symptomatic hypotension, bleeding.

How Supplied:
Ampules (2.9mL)—4
Starter Kit—1 (28 ampules with inhalation system)
Refill Kit—1 (28 ampules with accessories)