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

PATIENTS LIKE YOURS WERE STUDIED1

Tyvaso is a prostacyclin vasodilator indicated for the treatment of PAH (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms on a background of bosentan (an ERA) or sildenafil (a PDE-5 inhibitor).

See who was studied in the TRIUMPH I trial.

  • Bosentan
  • Sildenafil
  • 200-300 m
  • 301-359 m
  • 360-401 m
  • 402-450 m
  • Idiopathic/Heritable IPAH/HPAH
  • CTD
  • Other
  • FC III
  • FC IV
  • 18-45 years
  • 46-54 years
  • 55-63 years
  • 64-75 years
  • Female
  • Male

70%

In the TRIUMPH I trial,

165 out of 235 clinically stable patients were on background treatment with bosentan for at least 3 months.1

70%

70% Bosentan

30% Sildenafil

30%

In the TRIUMPH I trial,

70 out of 235 clinically stable patients were on background treatment with sildenafil for at least 3 months.1

30%

30% Sildenafil

70% Bosentan

25%

In the TRIUMPH I trial,

59 out of 235 patients had a baseline 6MWD between 200 and 300 m.1

25%

6MWD is one variable used to determine response to therapy in patients with PAH. Patients with a 6MWD of ≤380 m may have a worse prognosis.2

25%

In the TRIUMPH I trial,

59 out of 235 patients had a baseline 6MWD between 301 and 359 m.1

25%

6MWD is one variable used to determine response to therapy in patients with PAH. Patients with a 6MWD of ≤380 m may have a worse prognosis.2

25%

In the TRIUMPH I trial,

58 out of 235 patients had a baseline 6MWD between 360 and 401 m.1

25%

6MWD is one variable used to determine response to therapy in patients with PAH. Patients with a 6MWD of ≤380 m may have a worse prognosis.2

25%

In the TRIUMPH I trial,

59 out of 235 patients had a baseline 6MWD between 402 and 450 m.1

25%

6MWD is one variable used to determine response to therapy in patients with PAH. Patients with a 6MWD of ≤380 m may have a worse prognosis.2

56%

In the TRIUMPH I trial,

131 out of 235 patients had idiopathic
or heritable PAH.1

56%

56% Idiopathic/Heritable

33% CTD

11% Other

33%

In the TRIUMPH I trial,

77 out of 235 patients had
PAH secondary to CTD.1

33%

33% CTD

56% Idiopathic/Heritable

11% Other

11%

In the TRIUMPH I trial,

27 out of 235 patients had PAH secondary to HIV or previous use of anorexigens1

11%

11% Other

33% CTD

56% Idiopathic/Heritable

98%

In the TRIUMPH I trial, all patients had PAH (WHO Group 1), and nearly all had NYHA FC III symptoms.1


Per evidence-based treatment algorithms, prostacyclin class therapies should be considered for patients in FC III. Many of these patients are not on prostacyclin class therapy.3,4

98%

FC III

FC IV

2%

In the TRIUMPH I trial, all patients had PAH (WHO Group 1), and nearly all had NYHA FC III symptoms.1


Per evidence-based treatment algorithms, prostacyclin class therapies should be considered for patients in FC III. Many of these patients are not on prostacyclin class therapy.3,4

2%

FC IV

FC III

25%

In the TRIUMPH I trial,

59 out of 235 patients were between the ages of 18 and 45 years.1

25%

18-45 years

46-75 years

23%

In the TRIUMPH I trial,

55 out of 235 patients were between the ages of 46 and 54 years.1

23%

46-54 years

18-45 years; 55-75 years

27%

In the TRIUMPH I trial,

63 out of 235 patients were between the ages of 55 and 63 years.1

27%

55-63 years

18-54 years; 64-75 years

25%

In the TRIUMPH I trial,

58 out of 235 patients were between the ages of 64 and 75 years.1

25%

64-75 years

18-63 years

81%

In the TRIUMPH I trial,

191 out of 235 patients were female.1

81%

81% Female

19% Male

19%

In the TRIUMPH I trial,

44 out of 235 patients were male.1

19%

19% Male

81% Female

6MWD=6-minute walk distance; CTD=connective tissue diseases; FC=Functional Class; NYHA-FC=New York Heart Association Functional Class; TRIUMPH=TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension. TRIUMPH=TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension; WHO=World Health Organization.

NEXT: Learn more about the pivotal trial for Tyvaso.

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).

ERA=endothelin receptor antagonist; NYHA=New York Heart Association; PDE-5=phosphodiesterase-5;TRIUMPH=TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension.

References: 1. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2016. 2. McLaughlin V V, Gaine SP, Howard LS, et al. Treatment goals of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25)(suppl D):D51-D59. 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. Badesch DB, Raskob GE, Elliott CG. Pulmonary arterial hypertension: baseline characteristics from the REVEAL registry. Chest. 2010;137(2):376-366.

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).