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Inhaled Ventavis® (iloprost) Inhalation Solution Breathe In the Power of Prostacyclin In Pulmonary Arterial Hypertension (PAH) NYHA Class III or IV
     Safety Profile
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Safety Profile

† Adverse events reported by at least 4 iloprost patients and reported at least 3% more frequently for iloprost patients than placebo patients in the 12-week placebo-controlled study.

  • No catheter-related infections, as seen with IV prostacyclins1
  • No rebound PAH has been seen with Ventavis® (iloprost) Inhalation Solution upon dose discontinuation or interruption in clinical trials.2
In a small, randomized, double-blind, placebo-controlled study (the STEP trial)2
  • 34 patients treated with endothelin receptor antagonist (125 mg bid for at least 16 weeks) tolerated the addition of inhaled iloprost (up to 5 mcg 6 to 9 times per day during waking hours).2
    • The mean daily inhaled dose was 27 mcg and the mean number of inhalations per day was 5.6.

1. Olschewski H, Simonneau G, Galie N et al, for the Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002;347:322-329.
2. Ventavis (iloprost) Full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2009.



* In the AIR pivotal trial, Ventavis delivered significant patient improvement in a composite endpoint consisting of ≥10% increase in 6MWD, improvement in NYHA functional class, and lack of deterioration or death (p=0.0033).

IMPORTANT SAFETY INFORMATION:
In clinical studies, common adverse reactions due to Ventavis included vasodilation (flushing), cough, headache, trismus, and insomnia. Serious adverse events reported at a rate of less than 3% included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Vital signs should be monitored while initiating Ventavis. Ventavis should not be initiated in patients with systolic blood pressure less than 85 mmHg. Stop Ventavis immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.

Please see full Prescribing Information

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Ventavis, please call
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