IMPORTANT SAFETY INFORMATION FOR TYVASO
WARNINGS AND PRECAUTIONS
The efficacy of Tyvaso has not been established in patients with significant underlying lung disease
(such as asthma or chronic obstructive pulmonary disease). Patients with acute pulmonary
infections should be carefully monitored to detect any worsening of lung disease and loss of drug
Tyvaso is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension.
Titrate slowly in patients with hepatic or renal insufficiency, as exposure to treprostinil may be
increased in these patients.
Tyvaso inhibits platelet aggregation and increases the risk of bleeding, particularly in patients
Co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil may increase
exposure to treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin may decrease
exposure to treprostinil. Increased exposure is likely to increase adverse events, whereas
decreased exposure is likely to reduce clinical effectiveness.
DRUG INTERACTIONS / SPECIFIC POPULATIONS
The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase
the risk of symptomatic hypotension.
Co-administration of the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to oral
treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to oral
treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by
inhibitors or inducers of CYP2C8.
There are no adequate and well-controlled studies with Tyvaso in pregnant women. It is not known
whether treprostinil is excreted in human milk.
The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more than 3%
greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache
(41% vs 23%), throat irritation/ pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%),
flushing (15% vs <1%), and syncope (6% vs <1%).
Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension
(PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included
predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or
heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can
be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all
controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an
endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled
clinical experience was limited to 12 weeks in duration.
Please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual.
For additional information about Tyvaso, visit www.tyvaso.com or call 1-877- UNITHER (1-877-864-8437).