• VENTAVIS® (iloprost)

    INDICATION

    VENTAVIS® is a prostacyclin mimetic 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 diseases (23%).

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    RISK OF SYNCOPE

    • Monitor vital signs while initiating VENTAVIS®. Do not initiate VENTAVIS® in patients with systolic blood pressure below 85 mmHg.
    • 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.

    PULMONARY VENOUS HYPERTENSION

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

    BRONCHOSPASM

    • VENTAVIS® inhalation can induce bronchospasm. Bronchospasm may be more severe or frequent in patients with a history of hyperreactive airways.
    • VENTAVIS® has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.

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

    USE IN SPECIFIC POPULATIONS

    LACTATION

    • Advise not to breastfeed during treatment with VENTAVIS®.

    Please read full Prescribing Information.

    cp-134777v3

    INDICATION
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/VENTAVIS-pi.pdf

Complete the Prescription Process for VENTAVIS®

Downloadable Forms
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Complete the Prescription Process for VENTAVIS®

Writing the prescription is just the first step in starting a patient on VENTAVIS®. Next, the patient's healthcare team must complete and submit the relevant forms.

You Can Download Faxable Forms Below

Important Safety Information For

  • VENTAVIS®

    INDICATION

    VENTAVIS® is a prostacyclin mimetic 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 diseases (23%).

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    RISK OF SYNCOPE

    • Monitor vital signs while initiating VENTAVIS®. Do not initiate VENTAVIS® in patients with systolic blood pressure below 85 mmHg.
    • 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.

    PULMONARY VENOUS HYPERTENSION

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

    BRONCHOSPASM

    • VENTAVIS® inhalation can induce bronchospasm. Bronchospasm may be more severe or frequent in patients with a history of hyperreactive airways.
    • VENTAVIS® has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.

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

    USE IN SPECIFIC POPULATIONS

    LACTATION

    • Advise not to breastfeed during treatment with VENTAVIS®.

    Please read full Prescribing Information.

    cp-134777v3

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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INDICATIONS

IMPORTANT SAFETY INFORMATION