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

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Why Tyvaso?

It may be good to know that Tyvaso® is the #1 prescribed inhalable prostacyclin treatment for pulmonary arterial hypertension (PAH) and can improve the ability to exercise in people who also take bosentan (an endothelin receptor antagonist (ETRA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). You breathe it in 4 times a day, using a lightweight, portable inhalation system.

Benefits

  • Tyvaso is the ONLY inhalable prostacyclin treatment approved as an add-on to oral medications
  • Tyvaso treatments are taken 4x daily and can be adjusted and planned around daily activities
  • Improved ability to exercise at 12 weeks in patients taking Tyvaso, in addition to an oral medication*
  • Tyvaso is taken with the Tyvaso Inhalation System, which is lightweight (less than 10 oz), portable, and easy to use

Risks

  • Tyvaso may increase the risk of bleeding in people who take blood thinners (anticoagulants)
  • If you have low blood pressure, Tyvaso may lower your blood pressure further

Ask your doctor if you are not sure if this applies to you.

The most common side effects of Tyvaso include:

  • Coughing
  • Headache
  • Nausea
  • Reddening of your face and neck (flushing)
  • Throat irritation and pain
  • Fainting or loss of consciousness

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tyvaso. For more information, ask your doctor or specialty pharmacist.

You may also contact United Therapeutics Corporation at 1-877-864-8437 or via e-mail at drugsafety@unither.com to report suspected side effects, or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How Tyvaso Was Studied

Tyvaso was studied in one of the largest clinical trials to date of add-on therapy in patients with PAH. The goal of the trial, called TRIUMPH I, was to see if Tyvaso improved exercise ability in patients already taking an oral PAH medicine. Exercise ability was assessed using a test that measures the distance walked in 6 minutes (6-minute walk distance (6MWD)). Doctors commonly measure 6MWD to assess the ability of patients with PAH to do exercise.

  • The trial showed that after 12 weeks, patients taking Tyvaso had a median improvement of 20 meters (about 66 feet) in the 6MWD test1
  • 31% of Tyvaso patients improved by greater than 50 meters (about 164+ feet)1

For more information, download the Patient Package Insert. Also Available in Spanish

* Ability to exercise assessed using measures 6-minute walk distance (6MWD)

TRIUMPH=TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension

Indication

Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities.

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%).

Important Safety Information for Tyvaso

  • Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System
  • The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age
  • If you have low blood pressure, Tyvaso may cause symptomatic hypotension (low blood pressure)
  • Because Tyvaso reduces the ability of your blood to clot (coagulate), it may increase your risk for bleeding if you are taking blood thinners (anticoagulants), such as warfarin or heparin
  • The use of Tyvaso with diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase your risk for hypotension (low blood pressure)

Other medical conditions and medicines may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking, including:

  • If you are taking gemfibrozil (for high cholesterol) or rifampin (for infection), your Tyvaso dosage may need adjustment
  • If you have liver or kidney problems, your ability to tolerate Tyvaso may be affected
  • If you are pregnant, breast-feeding, or planning to become pregnant, talk with your healthcare provider about whether you should take Tyvaso

The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your doctor about any side effects that bother you or do not go away. Your doctor may be able to help you manage the side effects.

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).

1. 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;55:1915-22.

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