Safety Profile

  Adverse events* in AIR pivotal trial occurring in ≥3% of patients treated with Ventavis1  
  Adverse event Ventavis (n=101)
% 		Placebo (n=102)
% 		Placebo Subtracted
% 		 
  Vasodilation (flushing) 27 9 18  
  Cough increased 39 26 13  
Headache 30 20 10  
Trismus 12 3 9  
Insomnia 8 2 6  
Nausea 13 8 5  
Hypotension 11 6 5  
Vomiting 7 2 5  
Alk phos increased 6 1 5  
Flu syndrome 14 10 4  
Back pain 7 3 4  
Abnormal lab test 7 3 4  
Tongue pain 4 0 4  
Palpitations 7 4 3  
Syncope 8 5 3  
GGT increased 6 3 3  
Muscle cramps 6 3 3  
Hemoptysis 5 2 3  
Pneumonia 4 1 3  

*Adverse events reported by at least 4 Ventavis patients and reported at least 3% more frequently for Ventavis patients than placebo patients in a 12-week study.

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Respironics and I-neb Adaptive Aerosol Delivery (AAD) are trademarks of or belonging to Koninklijke Philips Electronics N.V.

The Ventavis 20 mcg/mL concentration order form is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Ventavis 10 mcg/mL ampules are still available. Ventavis should be taken 6 to 9 times daily, at least 2 hours apart.

For more information about Ventavis, please call 1-866-ACTELION (1-866-228-3546).

Indication and Important Safety Information

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Indication:

Ventavis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).

Important Safety Information

  • Hypotension leading to syncope has been observed; Ventavis should therefore 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.
  • Ventavis inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.
  • 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.
  • In clinical studies, the most common adverse events occurring more often (≥6%) in Ventavis-treated patients than in patients taking placebo included vasodilation (flushing) (27% vs 9%), cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), and insomnia (8% vs 2%).
  • Ventavis has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.
  • Ventavis also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.

Please see full Prescribing Information.