SUPPORTABLE

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

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Helpful PAH Websites

Refer your patients to the Tyvaso.com patient website where they can find important resources to help promote Tyvaso® adherence. Your patients may also benefit from visiting the websites listed below.

LivingPAH.com

Living PAH is a comprehensive support program for patients on Tyvaso® (treprostinil) Inhalation Solution or any United Therapeutics treatment. The program is dedicated to improving the lives of PAH patients by providing them with free information and personalized support to encourage treatment adherence and help them cope with their diagnosis. The free resources include disease education, regional educational events, treatment support services, emotional support, and reimbursement assistance. For more information, visit www.livingpah.com.

Caring Voice Coalition

Caring Voice Coalition (CVC) is an independent, national, nonprofit organization dedicated to helping patients affected by chronic disease. CVC supports patients in need through co-pay and premium assistance.

CVC’s Financial Assistance Program may pay for a portion or all of a patient’s costs under the patient’s health insurance plan.

Financial assistance is available for eligible patients who cannot afford:

  • Insurance premiums
  • Insurance co-payments
  • Medicare prescription co-payments

For more information on CVC’s Financial Assistance Program, call 1-888-267-1440 or visit www.caringvoice.org.

The Pulmonary Hypertension Association (PHA)

The PHA is a leading community-based organization for patients with PAH. Its mission is to find ways to prevent and cure PAH, while providing hope to the community of affected individuals. For more information, visit www.PHAssociation.org.

The National Heart Lung and Blood Institute (NHLBI)

The NHLBI is part of the National Institutes of Health (NIH), the agency of the U.S. Department of Health and Human Services that is largely responsible for conducting medical research. The NHLBI website has easy-to-understand information about various diseases that affect the heart and lungs. For more information, visit www.nhlbi.nih.gov and search for PAH.

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).

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