TYVASO DPI

AbsorptionTreprostinil plasma exposure data were obtained from a 6-treatment, 6-period, 6-sequence, crossover study of Tyvaso DPI and Tyvaso Inhalation Solution in healthy volunteers. The mean C max for the 16, 48, and 64 mcg doses of Tyvaso DPI were 0.39, 1.11, and 1.33 ng/mL, respectively, with corresponding median T max of 0.17 hr. The mean AUC 0-5hr for the 16, 48, and 64 mcg doses of Tyvaso DPI were 0.275, 0.774, and 0.964 hr∙ng/mL, respectively. Treprostinil systemic exposure (AUC 0-5hr a...

14.1 Pulmonary Arterial Hypertension (WHO Group 1) (TRIUMPH I) TRIUMPH I, was a 12-week, randomized, double-blind, placebo-controlled, multicenter study of patients with PAH (NCT00147199). The study population included 235 clinically stable subjects with PAH (WHO Group 1), nearly all with NYHA Class III (98%) symptoms who were receiving either bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor) for at least 3 months prior to study initiation. Concomitant therapy also could have included anticoagulants, other vasodilators (e.g., calcium channel blockers)...

The following potential adverse reactions are described in Warnings and Precautions (5): - Decrease in systemic blood pressure [see Warnings and Precautions (5.1) ] . - Bleeding [see Warnings and Precautions (5.2) ] . Most common adverse reactions (≥4%) are cough, headache, throat irritation/pharyngolaryngeal pain, nausea, flushing, dyspnea, and syncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medw...

None. None. ( 4 )

Tyvaso DPI may cause symptomatic hypotension. ( 5.1 ) Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding. ( 5.2 ) Tyvaso DPI dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 5.3 , 7.3 ) May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive. ( 5.4 ) 5.1 Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial ...

7 DRUG INTERACTIONS 7.1 Bosentan In a human pharmacokinetic study conducted with bosentan (250 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and bosentan were observed. 7.2 Sildenafil In a human pharmacokinetic study conducted with sildenafil (60 mg/day) and an oral formulation of treprostinil (treprostinil diolamine)...