Tyvaso

— THERAPEUTIC CATEGORIES —
  • Pulmonary hypertension

Tyvaso Generic Name & Formulations

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)

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

Metabolism

Hepatic (CYP2C8). 91% plasma protein bound.

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