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FREEDOM-M Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Meets Primary Endpoint
Date:6/6/2011

ry 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adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn.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 greater than or equal to 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 at www.Tyvaso.com or call 877-UNITHER (877-864-8437).

    About Remodulin (treprostinil) Injection

    Indication

    Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective ti
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    SOURCE United Therapeutics Corporation
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