YOU ARE NOW LEAVING TYVASO

FOR US HEALTHCARE
PROFESSIONALS ONLY

For the treatment of pulmonary arterial hypertension
(PAH) (WHO Group 1) to improve exercise ability.
For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
For US Healthcare Professionals Only

TRIUMPH Long-term, open-label
extension study

The long-term use and safety of Tyvaso have been studied in an open-label extension study (N=206) with a mean duration of 2.3 years and maximum exposure of 5.4 years.1

In the long-term follow-up of patients who were treated with Tyvaso in the pivotal study and the open-label extension (N=206), Kaplan-Meier estimates of survival were1:

Graph: Kaplan-Meier estimates of survival. These uncontrolled observations do not allow comparison with a control group not given Tyvaso and cannot be used to determine the long-term effect of Tyvaso on mortality. footnote: 1
graph fo: Kaplan-Meier estimates of survival. These uncontrolled observations do not allow comparison with a control group not given Tyvaso and cannot be used to determine the long-term effect of Tyvaso on mortality. footnote: 1

Safety and dosing were evaluated in the open-label extension of TRIUMPH I1:

89%

of patients achieved the target dose of 9 breaths, 4x daily

42%

of patients achieved a dose of 12 breaths, 4x daily

  • Maximum recommended dosage of is 9 breaths, 4x daily

The adverse events observed during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo-controlled trial. Serious adverse events included pneumonia (n=15) and hemoptysis (n=3).1

IMPORTANT SAFETY INFORMATION FOR TYVASO

WARNINGS AND PRECAUTIONS
DRUG INTERACTIONS / SPECIFIC POPULATIONS
ADVERSE REACTIONS

INDICATION

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.

TYVISIhcpJUN16

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).

TRIUMPH=TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension.

Reference: 1. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2016.

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 effect.
  • 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 receiving anticoagulants.
  • 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.
ADVERSE REACTIONS
  • 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%).

INDICATION

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.

TYVISIhcpJUN16

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).