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VELETRI® Website

VELETRI.com - This website contains information about treatment with VELETRI®. On this website, you can also get helpful information about your condition.

 

Authorization

Patient Authorization Form [PDF] - Allows you to authorize the use of your personal information for certain Janssen Patient Support Programs.

Patient Authorization Form [PDF] (en Español) - Allows you to authorize the use of your personal information for certain Janssen Patient Support Programs.

 

Patient Support

Steps to Getting Your Medicine [PDF] - A patient-friendly guide to the verification and delivery process.

Steps to Getting Your Medicine [PDF] (en Español) - A patient-friendly guide to the verification and delivery process.

 

Coverage

Medicare Open Enrollment Guide [PDF] - Even if you keep the same health plan, your benefits can change. This guide can help you review your coverage and make changes if needed during the open enrollment period so you can stay on treatment in the new benefit period.

Medicare Resource Guide [PDF] - Provides information on sources for cost support that may be available to patients enrolled in Medicare. Medicare Resource Guide [PDF] (en español).

Medicare Part D Resource for Patients [PDF] - Helps you understand the 4 phases of coverage (Deductible, Initial Coverage, Coverage Gap, and Catastrophic Coverage), and when you will enter the Coverage Gap (formerly known as the Donut Hole). Medicare Part D Resource for Patients [PDF] (en español).

Medicare Low-Income Subsidy (LIS) Brochure [PDF] - Offers information about extra help with prescription drug costs that is available to low-income residents of the United States enrolled in Medicare Prescription Drug Plans.

 

IMPORTANT SAFETY INFORMATION

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What is VELETRI®?

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?

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 healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information for VELETRI® and discuss any questions you have with your doctor.

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