I will be in your area soon and would like to set up an appointment to talk about Tyvaso. This direct-to-the-lungs prostacyclin analogue may be used in your practice to help treat patients with PAH.
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I’m sorry we didn’t have a chance to speak the last time I was in your area. Hopefully, we can meet up again soon. In the meantime, I’d like to share some useful information about Tyvaso.
Introduction 2
I hope you are doing well. I’m sorry I missed you the last time I stopped by your office. I left materials there for your review and wanted to follow up with some helpful information about Tyvaso.
Introduction 3
It was a pleasure meeting with you today to talk about Tyvaso. As a follow-up to our discussion, here is some information I thought you might like to review.
Introduction 4
As always, thank you for taking time out of your busy day to meet with me. Coming out of our conversation, I hope you’ll find the following information about Tyvaso helpful.
Introduction 5
Thank you for taking the time to speak with me about Tyvaso and sharing your thoughts. As you’re aware, when treating patients with PAH, expected events may arise. Please review the information I’ve provided below, and don’t hesitate to contact me with any questions.
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Tyvaso is a pulmonary and systemic vasodilator. Its efficacy was proven in the pivotal placebo-controlled TRIUMPH I study, where Tyvaso was added to a stable dose of bosentan or sildenafil for 12 weeks. With Tyvaso, median 6-minute walk distance improved by 20 m (P<0.001), which was in addition to the effects seen with background therapy. In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension.
In an open-label extension study of Tyvaso (mean duration: 2.3 years; maximum exposure: 5.4 years), 89% of patients achieved the target dose of 9 breaths, 4× daily, and 42% of patients achieved a dose of 12 breaths, 4× daily. Adverse events—including cough, throat irritation, and pharyngeal pain—were qualitatively similar to those observed in the phase III, 12-week, placebo-controlled trial.
Tyvaso is approved for use only with the Tyvaso Inhalation System, which allows your patients to set up the device once daily and schedule treatment sessions around their activities. Dosing should be titrated beginning with 3 breaths, 4× daily. If 3 breaths are not tolerated, then reduce to 1 or 2 breaths and increase the dose by 1 additional breath until the target dose of 9 breaths per session is reached, as tolerated.
There are methods available to help your patients if they are experiencing cough or throat irritation. Our website offers practical approaches to prepare for and manage these specific events.
Learn more about preparing your patients for Tyvaso
Please let me know if there’s any information you need to help make the most of our upcoming visit. My contact details are below if you would like to send questions in advance of our meeting.
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I will schedule a follow-up visit to continue our discussion. You may reach me via my contact information below if you need anything before we meet again.
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If you have questions about treatment with Tyvaso, our support offerings, or anything else we discussed, please let me know. My contact details are below, and I’m happy to help in any way I can.
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It was wonderful seeing you again. I hope you won’t hesitate to contact me if you have any questions before our next visit.
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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.
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.
