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

Ensure the Prostacyclin Pathway Is Addressed

Multiple pathways have been implicated in the pathogenesis of PAH. Current therapies focus on the imbalance between vasoconstriction and vasodilation.1

Critical PAH Pathways and Treatment Effects

cGMP=cyclic guanosine monophosphate; ERA=endothelin receptor antagonist; PDE-5=phosphodiesterase type 5; sGC=soluble guanylate cyclase.

Importance of prostacyclin

Prostacyclin is essential to normal lung function.5

  • Prostacyclin is a potent vasodilator that inhibits platelet aggregation6
  • Produced by endothelial cells, prostacyclin has effects directed toward the local pulmonary vascular wall and blood cells6
  • Patients with PAH may have decreased levels of prostacyclin synthase, which disrupts vascular homeostasis5,7

Expert recommendations

Expert recommendations suggest prostacyclin class therapy may be beneficial for patients in NYHA FC III.3

  • Analysis of the world's largest PAH registry, the REVEAL Registry®* by Badesch et al, demonstrated that 46% of patients with NYHA FC III are on prostacyclin therapy8

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).

*REVEAL Registry is a registered trademark of Actelion Pharmaceuticals LTD Corporation.

NYHA FC=New York Heart Association Functional Class.

References: 1. Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med. 2004;351(14):1425-1436. 2. Humbert M, Sitbon O, Chaouat A, et al. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006;173(9):1023-1030. 3. Galiè N, Corris PA, Frost A, et al. Updated treatment algorithm of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25)(suppl D):D60-D72. 4. Adempas [package insert]. Whippany, NJ: Bayer Healthcare Pharmaceuticals Inc.; 2013. 5. Tuder RM, Cool CD, Geraci MW, et al. Prostacyclin synthase expression is decreased in lungs from patients with severe pulmonary hypertension. Am J Respir Crit Care Med. 1999;159(6):1925-1932. 6. Gomberg-Maitland M, Olschewski H. Prostacyclin therapies for the treatment of pulmonary hypertension. Eur Respir J. 2008;31(4):891-901. 7. McLaughlin VV, McGoon MD. Pulmonary arterial hypertension. Circulation. 2006;114(13):1417-1431. 8. Badesch DB, Raskob GE, Elliott CG. Pulmonary arterial hypertension: baseline characteristics from the REVEAL registry. Chest. 2010;137(2):376-387.

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).