Breathing Technique

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

The patient should sit in a comfortable, upright position and pick up the I-neb® Adaptive Aerosol Delivery (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; 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 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.16

  Teaching patients the breathing technique  
  Step 1 Ask patient to sit down comfortably in an upright position.  
  Step 2 Turn the I-neb AAD System on.  
  Step 3 Direct patient to hold the I-neb horizontally with the screen facing down.  
  Step 4 Direct patient to seal his or her lips around the mouthpiece.  
  Step 5 Direct patient to breathe in and out through the mouth in a slow and relaxed manner.  
  Step 6 Explain that a vibration will be felt through the I-neb each time medication is delivered.  

The I-neb AAD System will sense the patient's breathing pattern on the first 3 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.

Explain to the patient that standing 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 he or 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 10 minutes, the treatment will commence from where the patient paused.

  Tips for patient breathing success  
  I Tell your patients to take LONG and SLOW breaths.
  •    1)
  • The longer a patient takes to breathe in, the more drug will be delivered to the lungs during that breath.
  •    2)
  • Your patient should try counting "one-one thousand, two-one thousand, three one-thousand" when breathing in.
  •    3)
  • Taking fast deep breaths means there's less time for the machine to deliver drug with each breath.
 
  II Remind your patient to keep the lips around the mouthpiece when breathing in and out.
  •    1)
  • The machine will sense your patient's breathing and deliver the drug.
 
  III Have your patients relax and not work too hard. SLOW and STEADY works best.  
  IV If your patient needs a break, he/she can stop, take a rest, and then start again.
  •    1)
  • The machine will continue from where the patient stopped.
  •    2)
  • Your patient should not take more than a 10-minute break during treatment; if a break lasts more than 10 minutes, the machine will automatically turn off and your patient will not be able to finish the treatment session.
 

INDICATION

VENTAVIS® (iloprost) Inhalation Solution 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

WARNINGS AND PRECAUTIONS

Risk of Syncope

  • Vital signs should be monitored while initiating VENTAVIS. Hypotension leading to syncope has been observed; VENTAVIS should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg.

Pulmonary Venous Hypertension

  • Stop VENTAVIS immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.

Bronchospasm

  • VENTAVIS inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.

ADVERSE REACTIONS

Serious Adverse Events

  • Serious adverse events reported include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.

Adverse Events

  • Adverse events reported in a Phase 3 clinical trial occurring with a ≥3% difference between VENTAVIS patients and placebo patients were vasodilation (flushing) (27% vs 9%), increased cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), insomnia (8% vs 2%), nausea (13% vs 8%), hypotension (11% vs 6%), vomiting (7% vs 2%), alkaline phosphatase increased (6% vs 1%), flu syndrome (14% vs 10%), back pain (7% vs 3%), tongue pain (4% vs 0%), palpitations (7% vs 4%), syncope (8% vs 5%), GGT increased (6% vs 3%), muscle cramps (6% vs 3%), hemoptysis (5% vs 2%), and pneumonia (4% vs 1%).

DRUG INTERACTIONS

Antihypertensives and Vasodilators

  • VENTAVIS has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.

Anticoagulants and Platelet Inhibitors

  • VENTAVIS also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants or platelet inhibitors.

Please see full Prescribing Information.

INDICATION

VENTAVIS® (iloprost) Inhalation Solution 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

WARNINGS AND PRECAUTIONS

Risk of Syncope

  • Vital signs should be monitored while initiating VENTAVIS. Hypotension leading to syncope has been observed; VENTAVIS should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg.

Pulmonary Venous Hypertension

  • Stop VENTAVIS immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.

Bronchospasm

  • VENTAVIS inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.

ADVERSE REACTIONS

Serious Adverse Events

  • Serious adverse events reported include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.

Adverse Events

  • Adverse events reported in a Phase 3 clinical trial occurring with a ≥3% difference between VENTAVIS patients and placebo patients were vasodilation (flushing) (27% vs 9%), increased cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), insomnia (8% vs 2%), nausea (13% vs 8%), hypotension (11% vs 6%), vomiting (7% vs 2%), alkaline phosphatase increased (6% vs 1%), flu syndrome (14% vs 10%), back pain (7% vs 3%), tongue pain (4% vs 0%), palpitations (7% vs 4%), syncope (8% vs 5%), GGT increased (6% vs 3%), muscle cramps (6% vs 3%), hemoptysis (5% vs 2%), and pneumonia (4% vs 1%).

DRUG INTERACTIONS

Antihypertensives and Vasodilators

  • VENTAVIS has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.

Anticoagulants and Platelet Inhibitors

  • VENTAVIS also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants or platelet inhibitors.

Please see full Prescribing Information.