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 predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).

• About Ventavis

• About the I-neb AAD
  System

•      Components

•      Cleaning the AAD System

•      Breathing Technique

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• Prescribing Information

• For Patients and
  Caregivers

How the AAD System Works

The I-neb AAD System uses Adaptive Aerosol Delivery (AAD) technology to precisely and reproducibly deliver Ventavis^® (iloprost) Inhalation Solution to every patient, at either dose (2.5 mcg or 5.0 mcg), using a single ampule of medication. The I-neb AAD System monitors a patient's unique breathing pattern and adapts to breathing changes during treatment. The I-neb AAD System delivers Ventavis in the form of a mist only upon inhalation. This is the time when the body can best absorb the medication.

With the I-neb AAD System, a medication chamber controls the dose and a control disc operates the I-neb AAD System. Once a patient receives a complete dose, the I-neb AAD System stops delivering aerosol and signals the user with visual and audible indicators.

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 brochospasm 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, common adverse reactions due to Ventavis included vasodilation (flushing), cough, headache, trismus, and insomnia. Ventavis has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.

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