Adverse Events Attributable to the Drug Delivery System Chronic infusions of epoprostenol are delivered using a small, portable infusion pump through an indwelling central venous catheter. During long-term follow-up, sepsis was reported at a rate of 0. This rate was higher than reported in patients using chronic indwelling central venous catheters to administer parenteral nutrition, but lower than reported in oncology patients using these catheters. Malfunctions in the delivery system resulting in an inadvertent bolus of or a reduction in epoprostenol were associated with symptoms related to excess or insufficient epoprostenol, respectively. Post-Marketing Experience In addition to adverse reactions reported from clinical trials, the following events have been identified during post-approval use of epoprostenol. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
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VELETRI should not be used chronically in patients who during dose initiation develop pulmonary edema, which may be associated with pulmonary veno-occlusive disease. VELETRI is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.
Each vial is for single use only; discard any unused solution. Use after reconstitution and immediate dilution to final concentration.
During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated. Unless contraindicated, administer anticoagulant therapy to patients receiving VELETRI to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale.
To reduce the risk of infection, use aseptic technique in the reconstitution and administration of VELETRI and in routine catheter care. Because epoprostenol is metabolized rapidly, even brief interruptions in the delivery of VELETRI may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia. Dosage of VELETRI during chronic use should be adjusted at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or the occurrence of adverse events associated with epoprostenol.
Following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours. Withdrawal Effects Abrupt withdrawal including interruptions in drug delivery or sudden large reductions in dosage of VELETRI may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia.
Abrupt withdrawal should be avoided. Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving epoprostenol. Although the relationship to epoprostenol administration has not been established, pulmonary embolism has been reported in several patients taking epoprostenol and there have been reports of hepatic failure.
When other antiplatelet agents or anticoagulants are used concomitantly, there is the potential for VELETRI to increase the risk of bleeding.
However, patients receiving infusions of epoprostenol in clinical trials were maintained on anticoagulants without evidence of increased bleeding.
In clinical trials, epoprostenol was used with digoxin, diuretics, anticoagulants, oral vasodilators, and supplemental oxygen. Please see full Prescribing Information. Related Links.
I.V. therapy made a little easier
The new 0. Until the newly approved formulation and vial strength become available, patients should continue to use VELETRI according to the current package insert, which can be found at www. VELETRI should not be used chronically in patients who develop pulmonary edema during dose initiation which may be associated with pulmonary veno-occlusive disease. During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely.
FDA Approves Actelion Pharmaceuticals US, Inc.'s SNDA for Second Generation VELETRI for Injection
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. Please talk to your doctor about all of your medications. Each vial is for single use only; discard any unused medication. 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. It is the use of these medications concomitantly in combination with VELETRI that may potentially cause an increase in the risk of bleeding. 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.
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