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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

Specialty Pharmacies for VENTAVIS®

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Specialty Pharmacies for VENTAVIS®

  1. Janssen CarePath
  2. VENTAVIS®
  3. Initiate Patient on VENTAVIS®

VENTAVIS® is not available through retail pharmacies. VENTAVIS® is distributed to patients by mail through a specialty pharmacy rather than through a retail pharmacy. When you enroll your patients, they are connected to a specialty pharmacy based on their health insurance plans or their healthcare teams’ preference.

Many specialty pharmacies have developed tools to help patients and healthcare providers keep track of treatment. These include call centers, websites, and apps that allow patients to:

  • Manage prescriptions and deliveries
  • Review insurance coverage
  • Track their spending
  • Connect with support services

Specialty pharmacies that offer VENTAVIS®

Once you have decided that VENTAVIS® is right for your patient and have completed the VENTAVIS® enrollment forms, a specialty pharmacy will be selected.

For information on any changes to the list of VENTAVIS® specialty pharmacies, speak with a Janssen CarePath Care Coordinator today by calling 866-228-3546, Monday–Friday, 8 AM to 8 PM ET.

Medication delivery and refills

Let your patient know that the specialty pharmacy will call them to confirm delivery details of their medication. The specialty pharmacy will also supply refills as long as the prescriber verifies the continued prescription.

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