Frequently Asked Questions

Can any significant drug interactions be expected with VENTAVIS® (iloprost) Inhalation Solution?

In studies in normal volunteers there was no pharmacodynamic interaction between intravenous iloprost and either nifedipine, diltiazem, or captopril.1 However, iloprost has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents. Since iloprost inhibits platelet function, there is a potential for increased risk of bleeding, particularly in patients maintained on anticoagulants.1

Although clinical studies have not been conducted with VENTAVIS, in vitro studies of iloprost indicate that no relevant inhibition of cytochrome P450 drug metabolism would be expected.1

What are the most common Adverse reactions and Serious Adverse reactions with VENTAVIS?

Serious Adverse Events

  • Serious adverse events reported included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Vital signs should be monitored while initiating VENTAVIS.1

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%).1

How can I manage the risk of syncope when starting treatment with VENTAVIS?

Vital signs should be monitored while initiating VENTAVIS. In patients with low systemic blood pressure, care should be taken to avoid further hypotension. VENTAVIS should not be initiated in patients with systolic blood pressure less than 85 mmHg. Physicians should be aware of the presence of concomitant conditions or drugs that might increase the risk of syncope. Syncope can also occur in association with pulmonary arterial hypertension, particularly in association with physical exertion. The occurrence of exertional syncope may reflect a therapeutic gap or insufficient efficacy, and the need to adjust dose or change therapy should be considered.1

How many times a day should patients inhale VENTAVIS, and do they need to take it during sleeping hours?

VENTAVIS should be taken 6 to 9 times per day during waking hours, according to individual need and tolerability (but not more than once every 2 hours). In the randomized, placebo-controlled, Phase 3 clinical trial, the mean number of inhalations per day was 7.3 and 90% of patients in the iloprost group never inhaled study medication during sleeping hours.1

What makes the I-neb® Adaptive Aerosol Delivery (AAD®) System unique?

The I-neb AAD System uses Adaptive Aerosol Delivery (AAD) technology to precisely and reproducibly deliver VENTAVIS to every patient, at either dose (2.5 mcg or 5.0 mcg), using a single ampule of medication.2

The I-neb AAD System monitors a patient's unique breathing pattern and continually adapts to breathing changes during treatment to deliver a precise dose. The I-neb AAD System delivers aerosolized VENTAVIS during the first 80% of inhalation, ensuring no medication is wasted in the deadspace on inhalation or lost to the environment on exhalation.2,16 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.

Why must VENTAVIS be administered with the I-neb AAD System?

Although there are many aerosol devices approved in the U.S., it is important that VENTAVIS be dosed only via the I-neb AAD System because only the I-neb AAD System has been FDA approved to deliver dosing of VENTAVIS.

How large is the I-neb AAD device?

The I-neb AAD device is a compact, lightweight, battery-powered system that is approximately 6 inches high and weighs less than 8 ounces. Each patient is provided with one I-neb AAD System and a convenient carrying bag, complete with room for supplies.23

 

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.