Tyvaso Generic Name & Formulations
Legal Class
Rx
General Description
Treprostinil 0.6mg/mL; soln for oral inhalation using Tyvaso Inhalation System.
Pharmacological Class
Prostacyclin analogue.
See Also
How Supplied
Ampules (2.9mL)—4; Starter Kit—1 (28 ampules with inhalation system); Refill Kit—1 (28 ampules with accessories); DPI Titration Kit—1 (112 cartridges [16mcg] + 84 cartridges [32mcg] w. 5 inhalers); (112 cartridges [16mcg] + 112 cartridges [32mcg] + 28 cartridges [48mcg] w. 5 inhalers); DPI Maintenance Kit—1 (112 cartridges [16mcg, 32mcg, 48mcg, or 64mcg] w. 5 inhalers); (112 cartridges [32mcg] + 112 cartridges [48mcg] w. 5 inhalers)
Manufacturer
Generic Availability
NO
Mechanism of Action
Treprostinil, a prostacyclin analogue, directly vasodilates pulmonary and systemic arterial vascular beds and inhibits platelet aggregation.
Tyvaso Indications
Indications
To improve exercise ability in patients with: pulmonary arterial hypertension (WHO Group 1) with NYHA Class III symptoms; and pulmonary hypertension associated with interstitial lung disease (WHO Group 3).
Tyvaso Dosage and Administration
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 doses of 9–12 breaths per session.
Children
<18yrs: not established.
Tyvaso Contraindications
Not Applicable
Tyvaso Boxed Warnings
Not Applicable
Tyvaso Warnings/Precautions
Warnings/Precautions
Risk of symptomatic hypotension in those with low systemic arterial pressure. Hepatic insufficiency; titrate slowly. Risk of bleeding. Asthma, COPD, or other bronchial hyperreactivity. For Tyvaso Inhalation Solution: avoid contact with eyes and skin, oral ingestion. Elderly. Pregnancy. Nursing mothers.
Tyvaso Pharmacokinetics
Elimination
Renal (79%), fecal (13%). Half-life: ~4 hours (Tyvaso Inhalation Solution); 27–50 minutes (Tyvaso DPI).
Tyvaso Interactions
Interactions
Do not use with other medications. May be potentiated by CYP2C8 inhibitor (eg, gemfibrozil). May be antagonized by CYP2C8 inducer (eg, rifampin).
Tyvaso Adverse Reactions
Adverse Reactions
Cough, headache, nausea, diarrhea, dizziness, flushing, throat irritation, pharyngolaryngeal pain, syncope, dyspnea; symptomatic hypotension, bleeding, bronchospasm.
Tyvaso Clinical Trials
See Literature
Tyvaso Note
Not Applicable
Tyvaso Patient Counseling
See Literature