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For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
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| GO WITH TYVASO: A DIRECT-TO-THE-LUNGS PROSTACYCLIN ANALOGUE1 |
| The Tyvaso pivotal clinical trial showed a 20 m peak median improvement in 6MWD when studied in 235 clinically stable patients with PAH.1,2*† |
| See the trial results |
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In TRIUMPH I, adding Tyvaso to background therapy improved median 6MWD at week 121,2*:
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Primary endpoint: 20 m peak (P<0.001)† |
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Secondary endpoint: 14 m trough† |
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TRIUMPH I was a 12-week placebo-controlled trial studying patients who were FC III or IV at baseline with 6MWD
between 200 m and 450 m and were on a stable dose of oral monotherapy (bosentan or sildenafil) for ≥3 months
before being randomized to add either Tyvaso or inhaled placebo 4 times daily.1,2
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| TYVASO SAFETY ASSESSED IN TRIUMPH I |
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Adverse events that occurred in ≥4% of patients taking Tyvaso and more frequently than placebo included1
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Cough |
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Headache |
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Throat irritation/pharyngolaryngeal pain |
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Nausea |
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Flushing |
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Syncope |
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| Discontinuation rates due to adverse events in the TRIUMPH I study were comparable between groups, with 7 patients in the Tyvaso group and 4 patients in the placebo group discontinuing.2 |
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| IMPORTANT SAFETY INFORMATION FOR TYVASO |
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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. |
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Tyvaso is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension. |
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Titrate slowly in patients with hepatic or renal insufficiency, as exposure to treprostinil may be increased in these patients. |
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Tyvaso inhibits platelet aggregation and increases the risk of bleeding, particularly in patients receiving anticoagulants. |
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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. |
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The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension. |
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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. |
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There are no adequate and well-controlled studies with Tyvaso in pregnant women. It is not known whether treprostinil is excreted in human milk. |
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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%).
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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%).
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The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
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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.
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| TYVISIhcpJUN16 |
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For more information about Tyvaso, please see Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual. Questions? Call Customer Service at 1-877-UNITHER (1-877-864-8437).
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6MWD=6-minute walk distance; FC=functional class; PAH=pulmonary arterial hypertension.
*Peak measured 10-60 minutes after dosing at week 12; trough measured ≥4 hours after dosing at week 12.
†Hodges-Lehmann median difference between Tyvaso treatment and placebo groups.
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References: 1. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2016.
2. 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.
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