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

•      How the AAD System
       Works

•      Cleaning the AAD System

• Services for Your Patients

• Resources

• Prescribing Information

• For Patients and
  Caregivers

Breathing Technique

Proper breathing is the single easiest way to help your patients improve treatment with Ventavis^® (iloprost) Inhalation Solution.

The patient should sit in a comfortable, upright position and pick up the I-neb AAD System with the display screen facing down. The mouthpiece should be held at a 90-degree angle to the mouth, like holding a hamburger; your patients may rest their elbows on a table while holding their I-neb AAD System. The I-neb AAD System should be held in this position for the entire treatment session.

Counsel your patient to keep the lips closed around the I-neb AAD mouthpiece when breathing in and out.

Because the drug is delivered only during the first 80% of inspiration, longer breaths mean that more Ventavis will be delivered, decreasing treatment times.

The I-neb AAD System will sense the patient's breathing pattern on the first three breaths and begin to deliver Ventavis on the fourth inhalation. When Ventavis delivery begins, the I-neb AAD System will vibrate each time there is an inhalation. This is normal and indicates that Ventavis is being delivered.

If, during treatment, the I-neb AAD System sounds 4 short beeps, it means that the I-neb AAD System is being held improperly, either at too high or too low of an angle. At the same time, the I-neb AAD System will display error code 66. The patient should reposition the I-neb AAD System at a 90-degree angle. This will reset the device and remove the error code. Treatment should then be continued.

Positioning oneself in front of a mirror to get a visual image of what a 90-degree angle looks and feels like can be useful when first starting treatment. At the end of each treatment, the I-neb AAD System buzzes to let the patient know that the treatment session is complete and a smiling face will appear on the I-neb AAD System screen.

If your patient needs a break, then she can take one. Have your patient rest a minute or two then restart treatment. Remember, it will take the I-neb AAD 3 breaths in and out to adapt to your breathing pattern before Ventavis will be delivered again. As long as treatment is started again within ten minutes, the treatment will commence from where the patient paused.

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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