Getting VELETRI® (epoprostenol) for Injection
VELETRI must be prescribed by your healthcare professional and initiated in a setting with adequate personnel, monitoring equipment, and emergency care. Patients are often started on VELETRI in the hospital. To receive this medication you will have a surgical procedure done to insert a permanent catheter (very thin tube) into a large vein near your heart. The other end of the catheter is attached to a small, portable pump that holds the medication and administers VELETRI continuously.
You will continue your VELETRI treatment at home. To get VELETRI sent to your home or your healthcare professional's office each month, your healthcare professional will enroll you in a program. VELETRI is not available through retail pharmacies; it is only available from a specialty pharmacy. The specialty pharmacy will continue to ship VELETRI, along with needed supplies, directly and conveniently to your home or healthcare professional's office each month.
Specialty Pharmacies*
Accredo Health Group, Inc.
1-866-344-4874
Caremark, L.L.C.
1-877-242-2738
*Disclaimer: Accredo Health Group, Inc., and Caremark, L.L.C., are independent specialty pharmaceutical service providers that provide medications and related services in the home setting. Accredo and Caremark have been contracted by Actelion Pharmaceuticals to distribute VELETRI.
When you start VELETRI I.V. therapy, you have the option to prepare and use your medicine immediately, or to prepare your medicine and store it in the refrigerator (36°F to 46°F/2°C to 8°C) for up to 8 days.1
In both cases, your healthcare professional will work closely with you 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 professional.
For more information about storing VELETRI, please click here or refer to the full Prescribing 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 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. VELETRI® (epoprostenol) for Injection Full Prescribing Information. Actelion Pharmaceuticals US, Inc.
