How Veletri Helps
When prepared and used as directed, Veletri may help you feel better by reducing the symptoms (breathlessness and fatigue) of PAH* and improving your ability to exercise (6-minute walk). Veletri was also shown to improve survival in patients with certain types of idiopathic or heritable PAH* in a 12 week study.
In clinical studies†, treatment with epoprostenol—the active ingredient in Veletri—resulted in:
- Improved survival (in NYHA Class III and IV patients with idiopathic or heritable PAH*) as measured at 12 weeks — None of the 41 patients receiving epoprostenol sodium died. — 8 of 40 (20%) patients receiving conventional therapy alone died (p=0.003).
- Significant improvement in several key heart functions
- Significant improvement in breathlessness and fatigue as measured using a patient questionnaire
- Improvement in or maintenance of functional class as measured by the NYHA classification
- Increased capacity for exercise
As you can see, Veletri can make an important difference in the lives of people with certain kinds of PAH*. And while the results may not be the same for everybody, you have the confidence of knowing that the active ingredient in Veletri (called epoprostenol) is proven therapy with a well-known safety profile.
Most commonly reported side effects are flushing, jaw pain, headache, low blood pressure, fast heartbeat, nausea, vomiting, flu-like symptoms, anxiety/nervousness, and diarrhea.
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.
†In 8- and 12-week clinical studies in patients treated with epoprostenol sodium plus conventional therapy or conventional therapy alone. Conventional therapy could include anticoagulants, oral vasodilators, diuretic agents, cardiac glycosides, and supplemental oxygen.1
*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.
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. 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 are the possible side effects of Veletri?
The most commonly reported side effects during clinical trials include flushing, jaw pain, headache, low blood pressure, fast heartbeat, nausea, vomiting, flu-like symptoms, anxiety/nervousness, and diarrhea.
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 the FDA at 1-800-FDA-1088.
Please see accompanying full prescribing information.
1. Veletri (epoprostenol for injection) Full Prescribing Information. Actelion Pharmaceuticals US, Inc. March 2011.
