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Important Safety Information
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  • 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

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

Medicare

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Medicare

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

Medicare is a government-funded program that provides healthcare coverage for:

  • People over age 65 with a work history
  • People with certain disabilities who have been disabled for 2 years or more
  • People who have end-stage renal disease (ESRD) or ALS (also called Lou Gehrig's disease)

Medicare is divided into 4 parts: A, B, C, and D.

Part A
Inpatient care in hospitals and skilled nursing facilities; hospice care
Part B
Doctor visits and other outpatient services; medications given by a healthcare provider
Part C
Medicare Advantage Part A and Part B offered by private health plans; most plans include prescription drug coverage
Part D
Prescription drug coverage

While Medicare covers many healthcare needs, it may not cover all the healthcare costs for each patient. The patient may have to pay a monthly premium for Medicare and a co-pay, co-insurance, or deductible.

Janssen CarePath can help Medicare patients with Benefits Investigations, Prior Authorization support, and information on cost support programs.

Medicare Resource Guide
Learn about the different parts of Medicare. Also see what it may cover, including medications.

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