HEALTHCARE PROFESSIONALS

Side Effects Associated With Veletri

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You should know that all medications affect each person differently. Veletri does have side effects and unique characteristics that must be routinely monitored by qualified medical personnel. Be sure to tell your doctor about all of the medications you are taking before you begin Veletri.

Symptoms of not enough Veletri. Your body may react to not having enough Veletri. Consult your doctor if you experience any of the following symptoms: cough, chest pain, fatigue/weakness, irregular heartbeat, shortness of breath, bluish skin discoloration.1

Symptoms of too much Veletri. Your body can also have an excessive amount of Veletri. Consult your doctor if you experience any of the following symptoms for more than several days: diarrhea, nausea, headache, vomiting, flushing, heart palpitations, lightheadedness/fainting.

Symptoms associated with dose increases and chronic Veletri infusion. After some time, your body will become accustomed to your Veletri dosage and will require a small increase of the dosage, as directed by your doctor. The following are common symptoms of Veletri therapy. If you experience any of these symptoms and have related questions, contact your healthcare provider: rash, jaw pain, flushing, diarrhea, headache, muscle pain, heart palpitations, low blood pressure, nausea and vomiting, anxiety/nervousness/tremor (shaking), chills/fever/sepsis/flu-like symptoms.

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

Read about the safety 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.

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.