Tyvaso® is only available through select Specialty Pharmacy Service (SPS) providers. To prescribe Tyvaso for your patients, complete
the Patient Referral Form and fax it to your preferred SPS provider.
Tyvaso Is Available Only Through the Following SPS Providers
To prescribe Tyvaso for your patients, complete the Patient Referral Form and
fax it to your preferred SPS provider. SPS provider support includes:
Patient assessment and evaluation, insurance verification, pretreatment training and ongoing support, and 24/7 hotline access
Tyvaso Is Supplied in the Following Configurations:
Tyvaso Inhalation System Starter Kit: 28 day supply of Tyvaso (7 foil pouches, each containing four 2.9 mL plastic ampules), 2 inhalation
devices and accessories, warranty card, Getting Started with Tyvaso Folder, and Instructions for Use Manual. The folder provides
a number of useful items to help patients manage their therapy, including a step-by-step instructional video on use of the
device (“Getting Started with Tyvaso”), a patient brochure ("Tyvaso User Guide"), and a daily diary (Tyvaso Treatment Tracker)
Tyvaso Inhalation Refill Kit: 28 day supply of Tyvaso (7 foil pouches, each containing four 2.9 mL plastic ampules),
device accessories, and the monthly Tyvaso Treatment Tracker
Tyvaso Supplemental Pack: 4 plastic ampule carton of Tyvaso
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