Clinical Improvement

VENTAVIS® (iloprost) Inhalation Solution is a synthetic analogue of prostacyclin (PGI2).1 It dilates systemic and pulmonary arterial vascular beds. It also affects platelet aggregation, although the relevance of this effect to the treatment of pulmonary arterial hypertension is unknown.1

Established efficacy in both Functional Class III and Functional Class IV patients1

6MWD in functional class III patients1

6MWD in functional class IV patients1

361-m mean 6MWD at baseline14
272-m mean 6MWD at baseline14

In clinical studies, VENTAVIS has been shown to help with the following1,4:

  • Significant improvement in a combined endpoint of clinical improvement—improvement in functional class, 10% or greater increase in individual walk distance, and lack of clinical deterioration or death (p=0.0033)1
  • Significant improvement in exercise capacity (p<0.01)1
  • Significant improvement in New York Heart Association (NYHA) Functional Class (p=0.03)4,14
  • Significant hemodynamic improvement for 3 key parameters (PVR, CO, and mPAP) (p<0.001)1,4
    • 32% decrease in PVR
    • 18% increase in CO
    • 9% decrease in mPAP
    • 3% increase (p=NS) in SVO2 from baseline at week 12 postinhalation
    • The relationship between hemodynamic changes and clinical effects is unknown
    • Placebo-corrected.

AIR Pivotal Trial: Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of VENTAVIS monotherapy compared with placebo in the treatment of PAH (WHO Group 1) NYHA Functional Class III or IV (n=146). Clinical improvement is a combined endpoint defined as ≥10% increase in 6MWD, improvement in NYHA Functional Class, and absence of clinical deterioration or death.1,4

Hemodynamics assessed at Week 12 before inhalation in both groups (at least 2 hours after previous dose, trough) and after inhalation in the VENTAVIS group (approximately 15 minutes after dose, peak). Study included patients with chronic thromboembolic disease (CTEPH) and all etiologies of PAH.1

For more information, 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.

SPECIFIC POPULATIONS

Lactation

  • Advise not to breastfeed during treatment with VENTAVIS.

Please see full Prescribing Information.

cp-134777

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.

SPECIFIC POPULATIONS

Lactation

  • Advise not to breastfeed during treatment with VENTAVIS.

Please see full Prescribing Information.

cp-134777