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Important Safety Information
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  • VENTAVIS® (iloprost)

    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%).

    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 the hypotensive effect of vasodilators and antihypertensive agents.

    USE IN SPECIFIC POPULATIONS

    LACTATION

    • Advise not to breastfeed during treatment with VENTAVIS®.

    Please read full Prescribing Information.

    cp-134777v2

    INDICATION
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INDICATIONS

IMPORTANT SAFETY INFORMATION

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

Medicaid

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Medicaid

  1. Janssen CarePath
  2. VENTAVIS®
  3. Insurance Coverage

Medicaid provides free or low-cost health coverage to Americans with limited income and resources. Low-income adults, children, pregnant women, elderly adults, and people with disabilities may be eligible. Medicaid is run by each state. The program is funded jointly by the states and the federal government. Coverage for VENTAVIS® may depend on the indication, along with other factors. Since information varies by state, we recommend contacting the state directly or reviewing its website.

Janssen CarePath can help Medicaid patients with Benefits Investigations and Prior Authorization support.

Visit your state’s Medicaid page for more coverage information. You can use the menu below to find contact details for your state.

Type or select your state

Important Safety Information For

  • VENTAVIS®

    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%).

    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 the hypotensive effect of vasodilators and antihypertensive agents.

    USE IN SPECIFIC POPULATIONS

    LACTATION

    • Advise not to breastfeed during treatment with VENTAVIS®.

    Please read full Prescribing Information.

    cp-134777v2

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS
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INDICATIONS

IMPORTANT SAFETY INFORMATION