Veletri® (Epoprostenol)

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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.

Understanding Your PAH Treatment

In pulmonary arterial hypertension (PAH), your body does not have enough of certain substances called prostacyclin and nitric oxide. At the same time, your body may have too much of a substance called endothelin. This lack of balance can cause your blood vessels to become narrow, leading to PAH.

The active ingredient of VELETRI® (epoprostenol) for Injection is epoprostenol, which is a prostacyclin. VELETRI adds back the prostacyclin your body is missing. Epoprostenol is a proven therapy with the goal of opening up, or dilating, the blood vessels in the lungs. Once the blood vessels are open, oxygen-rich blood can flow more easily.

A pulmonary arterial hypertension (PAH) medication such as VELETRI has a very short half-life (the time it takes for half of the medication to be broken down and eliminated from the body). VELETRI has a half-life of approximately 6 minutes.1 Because of this, VELETRI cannot be given as a pill that can be swallowed. Instead, it must be continuously delivered intravenously (through a vein) through an I.V. line. This line is connected to a catheter (a very thin tube) that is placed into your heart.

You will need a surgical procedure done with local anesthesia so that the catheter can be placed into a large vein near your heart. The other end of the catheter is attached to a small, portable pump that holds the medication. You must carry or wear the pump and keep it on at all times.

The treatment of pulmonary arterial hypertension with I.V. epoprostenol, including VELETRI, can seem complicated and frightening at first. Over time for many people, it becomes more routine and easier to manage. When you begin your treatment with VELETRI, your healthcare professional will get you started by guiding you step by step through how to prepare, use, and store your medication; how to care for your catheter; and what to do if your pump stops working.

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Importance of Taking VELETRI

It is very important to follow your healthcare professional’s instructions carefully regarding how to take VELETRI and how long to take it. Do not stop taking VELETRI for any reason, or lower the dose, unless your healthcare professional tells you to do so. Your healthcare professional can help you make taking VELETRI part of your daily routine.

Veletri Side Effects
  Side Effect Severity Mild Moderate Severe
Likely (>10%)

Flushing (58%)

Headache (49%)

Anxiety (11%)

Chest Pain (11%)

Nausea/Vomiting (32%)

Hypotension (16%)

Less Likely (1-10%)

Abdominal Pain (5%)

Musculoskeletal Pain (3%)

Dizziness (8%)

Slow Heart Rate (5%)

Rare (<1%)

 

You need to be prepared to work through the likely adverse effects. It would be advisable for patients to get prescriptions or guidance to deal with Diarrhea, Nausea and headache.

Headache is treated with Tylenol (Acetaminophen).

Diarrhea is typically treated with Imodium (Loperamide)-Purchase some before you start the medication to be prepared.

Nausea is treated first with Zofran (ondansetron).

Please talk to your provider about preparing for adverse effects.

Starting a New Medication

A new medication for you today. Specialty medications are different from regular prescriptions, as you may not pick them up from your local pharmacy. Specialty medications acquisition require more steps than a regular prescription. The process is as follows:

Prescription

  • Your doctor selects VELETRI as your new treatment.
  • Your healthcare team completes all the forms necessary to start you on the Actelion medicine

Insurance verification

  • The insurance company may ask your healthcare provider for additional information before they pay for your medicine.
  • The specialty pharmacy will contact you or your healthcare team if they need more information.
  • Prior Authorization is submitted to your insurance and they will review to see if it meets their criteria for approval. The process can take up to a couple of weeks depending on your insurance. If for some reason the insurance decides not to approve your medication, we will look to see why they made this decision and try to appeal this decision.
  • It is possible that your insurance will require a copay. In the case the copay is significant and you cannot afford the amount, you can ask special foundations for copay assistance. Non-Medicare patients can directly apply for assistance from the drug company manufacturing the drug. You will find more information in the Financial Assistance tab of this web page. Your physician’s office can also guide you in this matter. In spite of sometimes a hefty copay, through a variety of channels, patients usually are able to afford these specialty drugs- it does take some work by you to apply. You may receive phone calls during this time from the hub, the pharmacy, the drug company or assistance foundations to verify your income and assets. Please cooperate with them, they just want to help!

First treatment

  • Your healthcare team will start your first treatment in a hospital.

Delivery of medicine

  • VELETRI is shipped to you by a specialty pharmacy.
  • The shipment is usually quick, but the process leading up to your first delivery could take more than 2 weeks
  • Before shipping, the specialty pharmacy will call you to confirm some details, including the shipment date. Be sure to answer, or call the specialty pharmacy back if they leave a message

Refills

  • Once your doctor verifies your prescription, the specialty pharmacy will ship your refill.
  • Once you start taking VELETRI, be sure to contact your healthcare provider if you have any questions.

Remember, the call from your specialty pharmacy may come from a phone number that you don’t know. If you miss the call, it’s important that you call back.

Financial Support

Please Refer to Financial Support Page at MedEdCenter

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.

 

Patient Support
Expectations

Pulmonary Arterial Hypertension is a serious condition. The medications designed to fight the disease typically show benefit slowly, over months, with most needing 4 to 6 months for maximum effect. The adverse effects (Side-effects) of these medications, however happen upfront. Your body typically will get used to them either with time, or with additional natural remedy or drugs. This may also take 2 to 3 months. It is necessary that you have patience, and talk to your doctor or nurses about dealing with them. Sometimes slowing the planned increase or cutting down on medication for a while will allow your body to adjust. Discuss matters with your doctors’ office before taking action of your own. Patience is a virtue!

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