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Important Safety Information Full Prescribing Information Patient Package Insert Instructions For Use

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Cleaning and Care

The Tyvaso^® Inhalation System accessories require once-daily cleaning with mild, warm soapy water. Also, patients should use a clean cloth to wipe the interior of the device chamber once a week.

The carrying case provided may be used to store the components of the Tyvaso Inhalation System between treatment sessions and at the end of each day.

Once a month, patients will receive a new set of accessories as part of their Tyvaso Refill Kit.

The Tyvaso step-by-step instructional DVD “Getting Started with Tyvaso” is delivered with the Getting Started with Tyvaso folder to help patients learn how to assemble, use, and take care of the Tyvaso Inhalation System. The DVD is included in the Getting Started with Tyvaso folder, along with a patient brochure, Instructions for Use manual, and a Tyvaso Treatment Tracker.

Selected Important Safety Information

• 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adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn

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).

Tyvaso FAQs|Important Safety Information|Full Prescribing Information|Patient Package Insert|Instructions for Use Manual

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