Safety Profile for Veletri

Who should not use Veletri

• Patients with a certain type of congestive heart failure due to severe left ventricular systolic dysfunction
• Patients who develop pulmonary edema (excess fluid in the lungs) during dose initiation
• Patients with known hypersensitivity to the drug

Dose initiation (beginning therapy with Veletri)

Dose initiation with Veletri must be performed by medical personnel in a setting such as a hospital with equipment that can monitor vital signs and provide emergency care if needed. During dose initiation, increases in pulmonary artery pressure and cardiac output may occur. If this happens, your doctor may lower your Veletri dose.

Reconstituting and diluting Veletri

Veletri must be dissolved from a powder into liquid form (reconstituted) and further diluted before using. Reconstitute Veletri only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not reconstitute or dilute Veletri with any other solutions. Do not mix Veletri with other intravenous medications.

Side effects when beginning or increasing your dose of Veletri

In clinical studies, certain side effects required dose amounts to be lowered. The most common of these side effects were nausea, vomiting, headache, low blood pressure, and flushing. Other side effects included chest pain, anxiety, dizziness, slowed pulse, breathlessness, abdominal pain, bone and muscle pain, and rapid heartbeat.

Continuous use and dose adjustment

During continuous use, Veletri is delivered through a permanent catheter placed in a large vein in the chest. Patients using Veletri may also be given medication to reduce the risk of blood clots.

Contamination of the work area and supplies can lead to serious infections in individuals on intravenous drug therapy. To prevent infection, an aseptic technique must be used in routine catheter care and medication preparation.

Once you begin therapy with Veletri, your doctor may adjust your dose if symptoms of pulmonary hypertension come back or get worse. Your doctor may also change your dose if you experience side effects from Veletri. Following each dose adjustment, your blood pressure and heart rate should be monitored closely for several hours.

Stopping Veletri (including brief interruptions) or a sudden reduction in your Veletri dose may result in symptoms of pulmonary hypertension. These may include breathlessness, dizziness, and weakness. Abrupt withdrawal of Veletri should be avoided.

Using Veletri with other medications

Using Veletri with diuretics, blood pressure medications, or other vasodilators may cause reductions in blood pressure. When antiplatelet agents or anticoagulants (blood thinners) are used with Veletri, the risk of bleeding is increased.

Side effects during continuous use of Veletri

The symptoms of pulmonary hypertension are similar to some of the side effects of Veletri, such as dizziness and fainting. Other symptoms of pulmonary hypertension may include breathlessness, fatigue, chest pain, edema (swelling), hypoxia (less oxygen in the blood), heart failure, and paleness. Other side effects may be caused by the medication. These include headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousness. Talk to your doctor about any problems you have with side effects.

In clinical trials of epoprostenol (the active ingredient in Veletri), thrombocytopenia (a decrease in blood platelets) has been reported. Pulmonary embolism (blood clot) and liver failure have also been reported in patients taking epoprostenol. If you have concerns about the risks of Veletri therapy, discuss these with your doctor.

Read about Starting Veletri