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.1
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.
VELETRI provides:
- The option of up to once-weekly preparation (up to 8 cassettes at one time). When prepared, stored, and used as directed, VELETRI does not require ice packs. Plus, you will use readily available mixing liquids (diluents) from your pharmacy.2
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Flexible mixing (reconstitution) options2:
- With commercially available Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP
- Important: VELETRI is stable only when reconstituted as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. VELETRI must not be reconstituted or mixed with any other intravenous medications or solutions prior to or during drug administration. The same solution must be used for both reconstituting and diluting VELETRI. Do not combine sterile water with normal saline when preparing VELETRI.
VELETRI offers flexible preparation, storage, and administration options for treating PAH. Your healthcare professional will choose the one that is right for you.
Learn about what to expect with VELETRI and taking VELETRI
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.
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.
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 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.
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, and 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, and 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, and 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 accompanying full Prescribing Information.
cp-118962v3
1. McLaughlin V. Pulmonary hypertension. In: Goldman L, Schafer AI, eds. Goldman's
Cecil Medicine. 24th ed. Philadelphia, PA: Elsevier Saunders; 2012:389-397.
2. VELETRI® (epoprostenol) for Injection
Full Prescribing Information. Actelion Pharmaceuticals US, Inc.
