Support and Financial Assistance for VELETRI® (epoprostenol) for Injection

If you have insurance coverage when your healthcare provider first prescribes VELETRI, your healthcare team will submit your information to have your insurance plan pay for your prescription. Sometimes, your insurance plan needs additional information. Alternatively, if you do not have insurance but need assistance to meet out-of-pocket costs, there may be financial assistance options available. In both cases, an Actelion Pathways® Case Manager can help with the process.

Connecting with financial assistance programs

There are two programs that can help you pay for VELETRI. For information on these programs, contact an Actelion Pathways® Case Manager at 1-866-ACTELION (1-866-228-3546), Mon-Fri, 8 AM-8 PM ET.

Government insured

If you receive your medication through Medicare or other government-funded plans, you may be eligible for the following:

Independent foundations

There may be support available from independent third-party patient support foundations. An Actelion Pathways Case Manager can provide general information about resources.

Uninsured or underinsured

If you are uninsured or you have insurance but are unable to afford the out-of-pocket costs, you may be eligible for the following programs:

Patient Assistance Program (PAP)

A yearly program that helps eligible patients receive medicine at no cost. Contact an Actelion Pathways Case Manager to learn more and to ensure the PAP program is the best option for you before applying.

Additional support resources

The following organizations offer education and support to patients. Visit their websites for PAH information, news, and ideas about how to get involved with the PAH community.

The Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PAH to both physicians and patients.

The Scleroderma Foundation offers a site for scleroderma patients, caregivers, and family members—dedicated to support, education, and research.

Contact an Actelion Pathways Case Manager with questions at 1-866-ACTELION (1-866-228-3546), Mon-Fri, 8 AM-8 PM ET.

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What is VELETRI® (epoprostenol) for Injection?

VELETRI is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).

Studies showing VELETRI is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.

IMPORTANT SAFETY INFORMATION

Who should not take VELETRI?

VELETRI should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.

Some medications may interact with VELETRI. Please talk to your doctor about all of your medications.

What is the most important information I should know about VELETRI?

It is important to use VELETRI as directed by your doctor. VELETRI should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI with other intravenous medications. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI to direct sunlight.

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What is VELETRI® (epoprostenol) for Injection?

VELETRI is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).

Studies showing VELETRI is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.

IMPORTANT SAFETY INFORMATION

Who should not take VELETRI?

VELETRI should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.

Some medications may interact with VELETRI. Please talk to your doctor about all of your medications.

What is the most important information I should know about VELETRI?

It is important to use VELETRI as directed by your doctor. VELETRI should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI with other intravenous medications. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI to direct sunlight.

When you take epoprostenol for the first time, you must be in a setting (hospital or clinic) where you can be monitored for any serious side effects or in case of emergency. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking VELETRI, your doctor may prescribe another kind of medicine used to prevent blood clots. It is the use of these medications concomitantly (in combination) with VELETRI that may potentially cause an increase in the risk of bleeding.

Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure (hypotension). Do not stop using VELETRI without first talking to your doctor.

To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.

What are the possible side effects of VELETRI?

You may have side effects at the start of treatment or with dose increases. The most common side effects seen in at least 1% of patients were:

  • flushing
  • headache
  • nausea/vomiting
  • low blood pressure
  • anxiety/nervousness
  • chest pain
  • dizziness
  • slow heartbeat
  • abdominal pain
  • pain in the muscles and/or ligaments and bones
  • shortness of breath
  • back pain
  • sweating
  • upset stomach
  • numbness/increased sensitivity
  • fast heartbeat

The most common side effects in patients with PAH due to unidentified or hereditary factors with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:

  • flu-like symptoms
  • fast heartbeat
  • flushing
  • diarrhea
  • nausea/vomiting
  • jaw pain
  • pain in the muscles and/or ligaments and bones
  • anxiety/nervousness
  • dizziness
  • headache
  • numbness/increased sensitivity/tingling

The most common side effects in patients with PAH due to connective tissue disease with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:

  • flushing
  • low blood pressure
  • lack of appetite
  • nausea/vomiting
  • diarrhea
  • jaw pain
  • neck/joint pain
  • headache
  • skin ulcer
  • rash

Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VELETRI. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

What is VELETRI® (epoprostenol) for Injection?

+

VELETRI is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).

Studies showing VELETRI is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.


IMPORTANT SAFETY INFORMATION

+

Who should not take VELETRI?

VELETRI should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.

Some medications may interact with VELETRI. Please talk to your doctor about all of your medications.

What is the most important information I should know about VELETRI?

It is important to use VELETRI as directed by your doctor. VELETRI should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI with other intravenous medications. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI to direct sunlight.

When you take epoprostenol for the first time, you must be in a setting (hospital or clinic) where you can be monitored for any serious side effects or in case of emergency. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking VELETRI, your doctor may prescribe another kind of medicine used to prevent blood clots. It is the use of these medications concomitantly (in combination) with VELETRI that may potentially cause an increase in the risk of bleeding.

Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure (hypotension). Do not stop using VELETRI without first talking to your doctor.

To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.

What are the possible side effects of VELETRI?

You may have side effects at the start of treatment or with dose increases. The most common side effects seen in at least 1% of patients were:

  • flushing
  • headache
  • nausea/vomiting
  • low blood pressure
  • anxiety/nervousness
  • chest pain
  • dizziness
  • slow heartbeat
  • abdominal pain
  • pain in the muscles and/or ligaments and bones
  • shortness of breath
  • back pain
  • sweating
  • upset stomach
  • numbness/increased sensitivity
  • fast heartbeat

The most common side effects in patients with PAH due to unidentified or hereditary factors with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:

  • flu-like symptoms
  • fast heartbeat
  • flushing
  • diarrhea
  • nausea/vomiting
  • jaw pain
  • pain in the muscles and/or ligaments and bones
  • anxiety/nervousness
  • dizziness
  • headache
  • numbness/increased sensitivity/tingling

The most common side effects in patients with PAH due to connective tissue disease with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:

  • flushing
  • low blood pressure
  • lack of appetite
  • nausea/vomiting
  • diarrhea
  • jaw pain
  • neck/joint pain
  • headache
  • skin ulcer
  • rash

Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VELETRI. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.