For the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.* For U.S. Healthcare Professionals Only Patients: Start Here

ADD MORE: Tyvaso Is the Only PAH Treatment Approved as an Add-On to Oral Therapy1-6

Many patients plateau on oral therapy (PDE-5 inhibitor or ERA) within 12 weeks.7,8 In addition, PAH may be progressing even if patients seem stable.9 Adding Tyvaso can significantly improve peak 6MWD for patients stable on background oral monotherapy.1,10

Talk to your patients about the benefits and potential risks for Tyvaso. The most common adverse events in the placebo-controlled clinical study included cough, headache, throat irritation, nausea, flushing and syncope.1

Learn how Tyvaso can help your patients DO MORE:

  • Tyvaso is a prostacyclin analogue.1 Prostacyclin analogues may be beneficial when added to oral therapy.10 Evaluate the benefits and risks of Tyvaso therapy for your patients1
    Why Tyvaso?
  • Tyvaso targets an additional critical pathway.10 Prostacyclin analogues supplement prostacyclin, resulting in vasodilation and platelet aggregation inhibition11
    Mechanism of Action
  • Tyvaso improves exercise ability. After 1.7 years (mean) on oral monotherapy, adding Tyvaso for 12 weeks improved median 6MWD by 20 m (P<0.001) 1,10
    Clinical Study
  • Tyvaso has 4x-daily dosing. With Tyvaso, short treatment sessions can be scheduled around daily activities, approximately every 4 hours1
    Dosage & Administration
  • Tyvaso Inhalation System.The lightweight and portable Tyvaso Inhalation System provides a noninvasive inhaled delivery option — directly to the lungs12
    Tyvaso Inhalation System
  • Tyvaso adverse events. Tyvaso can increase the risk of bleeding in people who take anticoagulants and cause a further drop in blood pressure in people who are hypertensive.1
    Important Patient Considerations

Selected Important Safety Information

  • The safety and efficacy of Tyvaso have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect
  • Hepatic or renal insufficiency may increase exposure to Tyvaso and decrease tolerability. Tyvaso dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn

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.

Important Safety Information for Tyvaso

  • Tyvaso is intended for oral inhalation only. Tyvaso is approved for use only with the Tyvaso Inhalation System
  • The safety and efficacy of Tyvaso have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect
  • Tyvaso may increase the risk of bleeding, particularly in patients receiving anticoagulants
  • In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension. The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension
  • Hepatic or renal insufficiency may increase exposure to Tyvaso and decrease tolerability. Tyvaso dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn
  • 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 should be used in pregnancy only if clearly needed. Caution should be exercised when Tyvaso is administered to nursing women

For more information about Tyvaso, please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use Manual. Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).

References
1. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2011.
2. Ventavis [package insert]. San Francisco, CA: Actelion Pharmaceuticals US; 2012.
3. Revatio [package insert]. New York, NY: Pfizer Labs; 2012.
4. Adcirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2012.
5. Letairis [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2012.
6. Tracleer [package insert]. San Francisco, CA: Actelion Pharmaceuticals US; 2012.
7. Galiè N, Ghofrani HA, Torbicki A, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005;353(20):2148-2157.
8. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002;346(12):896-903.
9. Voelkel NF, Quaife RA, Leinwand LA, et al. Right ventricular function and failure: report of a National Heart, Lung, and Blood Institute working group on cellular and molecular mechanisms of right heart failure. Circulation. 2006;114(17):1883-1891.
10. McLaughlin VV, Benza RL, Rubin LJ, et al. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010;55(18):1915-1922.
11. Gomberg-Maitland M, Olschewski H. Prostacyclin therapies for the treatment of pulmonary arterial hypertension. Eur Respir J. 2008;31(4):891-901.
12. Channick RN, Voswinckel R, Rubin LJ. Inhaled treprostinil: a therapeutic review. Drug Des Devel Ther. 2012;6:19-28.

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