• VELETRI® (epoprostenol)

    VELETRI® is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.

    CONTRAINDICATIONS

    VELETRI® is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.

    VELETRI® should not be used chronically in patients who during dose initiation develop pulmonary edema, which may be associated with pulmonary veno-occlusive disease.

    VELETRI® is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.

    WARNINGS AND PRECAUTIONS

    General

    Reconstitute VELETRI® only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI® with any other parenteral medications or solutions prior to or during administration. Each vial is for single use only; discard any unused solution. Use after reconstitution and immediate dilution to final concentration. Use at room temperature (77°F/25°C). Do not expose VELETRI® to direct sunlight.

    VELETRI® should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension.

    Dose Initiation

    VELETRI® is a potent pulmonary and systemic vasodilator. Initiate VELETRI® in a setting with adequate personnel and equipment for physiologic monitoring and emergency care. During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated.

    Chronic Use and Dose Adjustment

    During chronic use, deliver VELETRI® continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, administer anticoagulant therapy to patients receiving VELETRI® to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. To reduce the risk of infection, use aseptic technique in the reconstitution and administration of VELETRI® and in routine catheter care.

    Because epoprostenol is metabolized rapidly, even brief interruptions in the delivery of VELETRI® may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia. Intravenous therapy with VELETRI® will likely be needed for prolonged periods, possibly years, so consider the patient’s capacity to accept and care for a permanent intravenous catheter and infusion pump.

    Dosage of VELETRI® during chronic use should be adjusted at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or the occurrence of adverse events associated with epoprostenol. Following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours.

    Withdrawal Effects

    Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of VELETRI® may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia. Abrupt withdrawal should be avoided.

    ADVERSE REACTIONS

    The most common and dose-limiting adverse events during dose initiation and escalation (≥1%) were flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), anxiety/nervousness/agitation (11%), chest pain (11%), dizziness (8%), bradycardia (5%), abdominal pain (5%), musculoskeletal pain (3%), dyspnea (2%), back pain (2%), sweating (1%), dyspepsia (1%), hypesthesia/paresthesia (1%), and tachycardia (1%).

    Adverse events occurring in patients with idiopathic or heritable PAH with ≥10% difference between epoprostenol and conventional therapy alone were chills/fever/sepsis/flu-like symptoms (25% vs 11%), tachycardia (35% vs 24%), flushing (42% vs 2%), diarrhea (37% vs 6%), nausea/vomiting (67% vs 48%), jaw pain (54% vs 0%), myalgia (44% vs 31%), nonspecific musculoskeletal pain (35% vs 15%), anxiety/nervousness/tremor (21% vs 9%), dizziness (83% vs 70%), headache (83% vs 33%), and hypesthesia/hyperesthesia/paresthesia (12% vs 2%).

    Adverse events occurring in patients with PAH/CTD with ≥10% difference between epoprostenol and conventional therapy alone were flushing (23% vs 0%), hypotension (13% vs 0%), anorexia (66% vs 47%), nausea/vomiting (41% vs 16%), diarrhea (50% vs 5%), jaw pain (75% vs 0%), pain/neck pain/arthralgia (84% vs 65%), headache (46% vs 5%), skin ulcer (39% vs 24%), and eczema/rash/urticaria (25% vs 4%).

    Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving epoprostenol.

    Although the relationship to epoprostenol administration has not been established, pulmonary embolism has been reported in several patients taking epoprostenol and there have been reports of hepatic failure.

    DRUG INTERACTIONS

    Additional reductions in blood pressure may occur when VELETRI® is administered with diuretics, antihypertensive agents, or other vasodilators. When other antiplatelet agents or anticoagulants are used concomitantly, there is the potential for VELETRI® to increase the risk of bleeding. However, patients receiving infusions of epoprostenol in clinical trials were maintained on anticoagulants without evidence of increased bleeding. In clinical trials, epoprostenol was used with digoxin, diuretics, anticoagulants, oral vasodilators, and supplemental oxygen. However, patients on digoxin may show elevations of digoxin concentrations after initiation of therapy with epoprostenol, which may be clinically significant in patients prone to digoxin toxicity.

    Please read full Prescribing Information.

    cp-115420v3

    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/VELETRI-pi.pdf

Helping Patients Afford VELETRI®

Downloadable Forms
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Helping Patients Afford VELETRI®

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking VELETRI®. Download a summary of affordability options or see a full list of options below.

 

Select your patient’s coverage status for relevant resources. 

For Patients with Commercial or Private Insurance

Janssen CarePath does not currently offer an affordability program for VELETRI®. Here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with Government Coverage

Even if your patients have government coverage like Medicare, we can identify programs that may help them afford their medications. Here are some independent programs that may be right for them.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicare Part D Extra Help — Low-Income Subsidy
This program gives "extra help" to patients with limited income and resources. It can help them:
  • Pay their monthly premiums
  • Reduce or eliminate their deductible
  • Reduce or eliminate their co-insurance and co-payments
  • Have no gap in coverage
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with No Insurance Coverage

If your patients need help with drug costs, we can identify programs that may help them afford their medications.

Here are some programs that are not offered by Janssen. Each program has its own eligibility rules.

Take a look and see which ones may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Janssen CarePath does not currently offer an affordability program for VELETRI®. Here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicare Part D Extra Help — Low-Income Subsidy
This program gives "extra help" to patients with limited income and resources. It can help them:
  • Pay their monthly premiums
  • Reduce or eliminate their deductible
  • Reduce or eliminate their co-insurance and co-payments
  • Have no gap in coverage
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Important Safety Information For

  • VELETRI®

    VELETRI® is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.

    CONTRAINDICATIONS

    VELETRI® is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.

    VELETRI® should not be used chronically in patients who during dose initiation develop pulmonary edema, which may be associated with pulmonary veno-occlusive disease.

    VELETRI® is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.

    WARNINGS AND PRECAUTIONS

    General

    Reconstitute VELETRI® only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI® with any other parenteral medications or solutions prior to or during administration. Each vial is for single use only; discard any unused solution. Use after reconstitution and immediate dilution to final concentration. Use at room temperature (77°F/25°C). Do not expose VELETRI® to direct sunlight.

    VELETRI® should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension.

    Dose Initiation

    VELETRI® is a potent pulmonary and systemic vasodilator. Initiate VELETRI® in a setting with adequate personnel and equipment for physiologic monitoring and emergency care. During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated.

    Chronic Use and Dose Adjustment

    During chronic use, deliver VELETRI® continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, administer anticoagulant therapy to patients receiving VELETRI® to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. To reduce the risk of infection, use aseptic technique in the reconstitution and administration of VELETRI® and in routine catheter care.

    Because epoprostenol is metabolized rapidly, even brief interruptions in the delivery of VELETRI® may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia. Intravenous therapy with VELETRI® will likely be needed for prolonged periods, possibly years, so consider the patient’s capacity to accept and care for a permanent intravenous catheter and infusion pump.

    Dosage of VELETRI® during chronic use should be adjusted at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or the occurrence of adverse events associated with epoprostenol. Following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours.

    Withdrawal Effects

    Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of VELETRI® may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia. Abrupt withdrawal should be avoided.

    ADVERSE REACTIONS

    The most common and dose-limiting adverse events during dose initiation and escalation (≥1%) were flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), anxiety/nervousness/agitation (11%), chest pain (11%), dizziness (8%), bradycardia (5%), abdominal pain (5%), musculoskeletal pain (3%), dyspnea (2%), back pain (2%), sweating (1%), dyspepsia (1%), hypesthesia/paresthesia (1%), and tachycardia (1%).

    Adverse events occurring in patients with idiopathic or heritable PAH with ≥10% difference between epoprostenol and conventional therapy alone were chills/fever/sepsis/flu-like symptoms (25% vs 11%), tachycardia (35% vs 24%), flushing (42% vs 2%), diarrhea (37% vs 6%), nausea/vomiting (67% vs 48%), jaw pain (54% vs 0%), myalgia (44% vs 31%), nonspecific musculoskeletal pain (35% vs 15%), anxiety/nervousness/tremor (21% vs 9%), dizziness (83% vs 70%), headache (83% vs 33%), and hypesthesia/hyperesthesia/paresthesia (12% vs 2%).

    Adverse events occurring in patients with PAH/CTD with ≥10% difference between epoprostenol and conventional therapy alone were flushing (23% vs 0%), hypotension (13% vs 0%), anorexia (66% vs 47%), nausea/vomiting (41% vs 16%), diarrhea (50% vs 5%), jaw pain (75% vs 0%), pain/neck pain/arthralgia (84% vs 65%), headache (46% vs 5%), skin ulcer (39% vs 24%), and eczema/rash/urticaria (25% vs 4%).

    Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving epoprostenol.

    Although the relationship to epoprostenol administration has not been established, pulmonary embolism has been reported in several patients taking epoprostenol and there have been reports of hepatic failure.

    DRUG INTERACTIONS

    Additional reductions in blood pressure may occur when VELETRI® is administered with diuretics, antihypertensive agents, or other vasodilators. When other antiplatelet agents or anticoagulants are used concomitantly, there is the potential for VELETRI® to increase the risk of bleeding. However, patients receiving infusions of epoprostenol in clinical trials were maintained on anticoagulants without evidence of increased bleeding. In clinical trials, epoprostenol was used with digoxin, diuretics, anticoagulants, oral vasodilators, and supplemental oxygen. However, patients on digoxin may show elevations of digoxin concentrations after initiation of therapy with epoprostenol, which may be clinically significant in patients prone to digoxin toxicity.

    Please read full Prescribing Information.

    cp-115420v3

    INDICATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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IMPORTANT SAFETY INFORMATION