Frequently Asked Questions

What is Veletri?
What is epoprostenol?
What is I.V. therapy?
How does the I.V. line get placed?
Who should take Veletri?
Who should not take Veletri?
How can Veletri help me?
How quickly does Veletri start working?
What are the side effects associated with Veletri?
How do I take Veletri?
How do I know what my dosage of Veletri should be?
How do I prepare and store Veletri?
Does Veletri require the use of ice packs?
How do I get Veletri?
What is important for me to know about taking Veletri?
What should my doctor and I consider before taking Veletri?
What if I have a problem with my catheter?
Where can I learn more about Veletri and PAH^*?
How do I find out if my insurance or Medicare covers the cost of Veletri?

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.

What is epoprostenol?

Epoprostenol is in a group of drugs called prostacyclin.¹ When given continuously, prostacyclins such as epoprostenol add back the prostacyclin your body is missing. Epoprostenol helps open up (dilate) blood vessels in the lung allowing blood to flow more easily.

What is I.V. therapy?

Epoprostenol medications such as Veletri have a very short half-life (the time it takes for half of the medication to be broken down and eliminated from the body). Because of this, Veletri cannot be given as a pill that can be swallowed. Instead, it must be continuously delivered through an I.V. line. This line is connected to a catheter that is placed in the heart.

How does the I.V. line get placed?

In a surgical procedure done with local anesthesia,¹ a doctor (surgeon) puts the catheter (very thin tube) into your heart. The doctor then connects the catheter line to a small, battery-powered pump that delivers the medication. Veletri, in liquid form, is stored in a small, removable cassette attached to the pump.

Who should take 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.

Who should not take Veletri?

You should not take Veletri if you have congestive heart failure due to severe left ventricular systolic dysfunction. You should also not take Veletri if you develop pulmonary edema (fluid in their lungs) during the beginning of therapy. People who have an allergy to the drug or to similar compounds should not use Veletri.³

How can Veletri help me?

In clinical trials, epoprostenol has been proven to improve survival in patients with certain types of idiopathic or heritable PAH^* in a 12 week study.

How quickly does Veletri start working?

In clinical studies, at 8 and 12 weeks of epoprostenol therapy, people showed improvements in their ability to exercise (measured by how far they could walk in 6 minutes) and a reduction in symptoms, such as shortness of breath and fatigue. In some people, improvements were shown as early as 1 week.³

What are the side effects associated with Veletri?

The most common side effects associated with starting or increasing the dose of epoprostenol include headache, low blood pressure, flushing, chest pain, anxiety, dizziness, change in heart rate, breathlessness, stomach pain, and musculoskeletal pain.³

The most common side effects associated with chronic use of epoprostenol include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness.³

Other side effects can occur. If you experience any side effects while on Veletri, be sure to talk to your doctor.

How do I take Veletri?

Veletri is administered continuously for 24 hours via a portable pump.³ It is delivered through a very thin tube called a catheter into a large vein near the heart. One end of the catheter is surgically implanted in the chest while the other end is attached to a small, portable pump that holds the medication. Your pump should be on and you must carry or wear the pump at all times.³

To avoid potential interruptions in drug delivery, be sure to have access to a backup infusion pump and intravenous infusion sets.

How do I know what my dosage of Veletri should be?

The amount of Veletri you need on a continuous basis will be determined by your doctor and may change during your course of therapy. Your portable infusion pump will control the rate of medication you receive. Do not, on your own, abruptly lower your dose of Veletri or stop taking it. All dose changes must be closely monitored by your doctor.³

How do I prepare and store Veletri?

Vials of Veletri powder must be reconstituted (dissolved) and then further diluted with easy-to-find Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Veletri should not be mixed with any other solutions or medications before or during administration.³

Though everyone is different, many people start Veletri I.V. therapy by preparing and using their medicine immediately, or even twice a day for some patients. As their doctor increases their dose of medicine, they may be given the option of preparing their medicine every other day. At higher doses, there is even the option of preparing up to 7 days' worth of medicine in advance. In all cases, your healthcare provider will work closely with you to find the best dose, and give you specific directions for preparing, storing, and using your medicine. Remember: never change the way you prepare or store Veletri unless instructed to do so by your healthcare provider.

For more information about storing Veletri, please click here or refer to the accompanying full prescribing information.

Does Veletri require the use of ice packs?

Veletri is the only medicine of its kind that gives you the option of up to once-weekly preparation and when prepared, stored and used as directed, Veletri does not require ice packs. Plus, you don't need special mixing liquids (diluents) to prepare your medicine.

How do I get Veletri?

Veletri must be prescribed by a doctor. It is not available through retail pharmacies; rather, it is carried by a specialty pharmacy, called Accredo Health Group, Inc.. Accredo will ship Veletri and the pump, along with needed supplies, directly and conveniently to your home or doctor's office each month.

What is important for me to know about taking Veletri?

Your doctor and Accredo Health Group, Inc. will monitor your dose of Veletri while you are in the hospital. 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. Do not freeze Veletri or expose 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. Use of these types of medicines may increase 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 should my doctor and I consider before taking Veletri?

Your decision to receive Veletri should be based on the understanding that there is a high likelihood that therapy with Veletri will be needed for prolonged periods, possibly years. Your doctor will carefully consider your ability to accept and care for a permanent intravenous (I.V.) catheter and infusion pump.³

What if I have a problem with my catheter?

While catheter-related problems are not common, you should know how to respond to one if it occurs. Some problems may include the catheter oozing, leaking, falling out, or developing a crack. If you have a problem with your catheter, see a medical professional as soon as possible or call 9-1-1.

The PHA Association website offers additional tips for how to develop an emergency plan to deal with catheter-related problems.

Where can I learn more about Veletri and PAH^*?

Your healthcare team is the best source of information for any questions or concerns you may have about your therapy or your condition. They will be able to provide the personal care and attention you need. Accredo Health Group, Inc. Patient Support is also available 24 hours a day to answer any questions you might have about Veletri or PAH^*. Call Accredo Health Group, Inc. Patient Support at 1-866-FIGHT-PH (1-866-344-4874).

How do I find out if my insurance or Medicare covers the cost of Veletri?

Accredo Health Group, Inc. will help answer any questions you may have about Veletri and your Insurance. Accredo Health Group, Inc. provides support on reimbursement and pharmacy benefits. You can read more here or call Accredo Health Group, Inc. at 1-866-FIGHT-PH (1-800-344-4874) or PAH^* Pathways at 1-866-ACTELION (1-866-228-3546).

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