appear [15,000:<15,000 (prepared using 0.5-mg vial) 48 hours 24 hours ≥15,000 to> <60,000 (prepared using 1.5-mg vials) 48 hours 48 hours ≥60,000 (prepared using 1.5-mg vials) 72 hours 48 hours Table 2. Maximum Duration of Infusion of Veletri Solutions at Temperatures 40 C60 Final Concentration (ng/mL) Temperatures Immediate Administration Administration After Storage at 2 8 C for 8 Days> <60,000 >25 C to 30 C 24 hours 24 hours ≥60,000 >25 C to 30 C 48 hours 48 hours ≥60,000 >30 C and 40 C 24 hours Rate of Administration Adjust infusion rates only under the direction of a physician, except in life-threatening situations (e.g., unconsciousness, collapse). 1 60 Observe patient and monitor standing and supine BP and heart rate for several hours following changes in infusion rates. 1 60 61 Avoid abrupt discontinuance or sudden large reductions in infusion rates. 1 10 12 60 61 (See Abrupt Withdrawal under Cautions.) Consult manufacturer s labeling for specific instructions on selection of infusion rate and drug concentration. 1 60 61 Dosage Available as epoprostenol sodium; dosage expressed in terms of epoprostenol. 1 2 60 Considerable interindividual variability in patient response; individualize dosage. 7 8 10 41 48 Titrate dosages carefully until desired therapeutic effect achieved or intolerable adverse effects occur. 1 10 60 61 Adults Pulmonary Arterial Hypertension Initiation and Titration of Therapy Continuous IV Infusion Initially, 2 ng/kg per minute (or a lower dose if not tolerated); increase in increments of 2 ng/kg per minute at intervals of ≥15 minutes until dose-limiting pharmacologic effects are elicited or a tolerance limit to the drug is established and further increases in the infusion rate are not clinically warranted. 1 60 Maintain dosage at a level where pharmacologic effects are tolerated. 1 60 Infusion rates may be calculated using the following formula: 1 60 Infusion rate (mL/hr) = [dose (ng/kg per min) wt (in kg) 60 min/hr] / final concentration of epoprostenol solution (ng/mL) In clinical studies in patients with PAH associated with the scleroderma spectrum of diseases, the average initial dosage of 2.2 ng/kg per minute was increased during the first week of therapy to 4.1 ng/kg per minute on day 7, and the mean dosage was 11.2 ng/kg per minute by the end of week 12; incremental increases in dosage averaged 2 3 ng/kg per minute every 3 weeks. 1 60 Long-term Therapy Continuous IV Infusion During long-term infusion, dosage increases generally are required based on persistence, recurrence, or worsening of disease symptoms; dosage reductions may be needed because of adverse effects. 1 60 Adjust dosage in increments of 1 2 ng/kg per minute at intervals of ≥15 minutes. 1 60 If dose-limiting adverse effects occur, decrease dosage gradually in decrements of 2 ng/kg per minute at intervals of ≥15 minutes until dose-limiting effects resolve; avoid abrupt withdrawal or sudden large reductions in infusion rates. 1 10 12 60 (See Abrupt Withdrawal under Cautions.) Prolonged therapy may cause tachyphylaxis and require periodic dosage adjustments. 7 10 35 41 47 (See Dosage Titration under Cautions.) In clinical studies, therapy was tapered in patients receiving lung transplants after initiation of cardiopulmonary bypass. 1 Limited data suggest that patients who are stable on Flolan therapy may be transitioned directly to the Veletri preparation at the same dosage without any change in clinical efficacy or tolerability. 66 67 Special Populations Geriatric Patients Select initial dosage in geriatric patients with caution (at low end of dosage range) and titrate carefully because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. 1 60 Cautions for Epoprostenol Sodium Contraindications Long-term use in CHF due to severe left ventricular systolic dysfunction. 1 60 Long-term use in patients who develop pulmonary edema during initial dosage titration. 1 60 Known hypersensitivity to epoprostenol or structurally related drugs. 1 60 Warnings/Precautions Warnings Solution and Drug Compatibility Reconstitute and dilute using only the appropriate diluent specified by the manufacturer. 1 60 61 (See Reconstitution and Dilution under Dosage and Administration.) Do not admix or infuse in the same IV line with other solutions or drugs. 1 60 Abrupt Withdrawal Avoid abrupt discontinuance or sudden large reductions in dosage. 1 10 12 60 Because of the drug s rapid metabolism, abrupt withdrawal (including interruptions in drug delivery), sudden large reductions in dosage, or even brief interruptions in drug delivery may result in symptoms associated with rebound pulmonary hypertension, e.g., dyspnea, dizziness, asthenia, and/or death. 1 8 10 19 60 Patient should have access to a backup IV infusion device and infusion sets to avoid interruptions in drug delivery due to equipment malfunction. 1 47 60 Sepsis Aseptic technique must be used in routine catheter care and in the reconstitution and administration of drug solutions. 1 64 Local infection and sepsis associated with drug delivery system (long-term indwelling central venous catheter) reported. 1 2 5 10 11 12 19 28 41 60 General Precautions Use Restrictions Should be used only by qualified clinicians experienced in the diagnosis and management of PAH. 1 23 60 Carefully establish the diagnosis of PAH before use. 1 60 Consider referral of patients to specialized centers experienced in the management of pulmonary vascular diseases. 10 11 16 18 23 31 Decision to initiate therapy must include careful consideration of the high likelihood that therapy will be needed for prolonged periods, possibly years, and of the patient s ability to accept and care for a permanent IV catheter and infusion device. 1 60 Initial dosage titration should be performed in a medically supervised setting adequately equipped for physiologic monitoring and emergency care. 1 60 Increases in Pulmonary Arterial Pressure Asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output reported rarely during initial dosage titration; such increases in pulmonary artery pressure do not necessarily preclude long-term therapy and may be controlled with dosage reduction. 1 60 Initial dosage titration has been performed with and without right heart catheterization in clinical studies. 1 41 60 Hematologic Effects Inhibits platelet aggregation; potential risk of hemorrhage, particularly in patients with increased risk of bleeding (e.g., concomitant antiplatelet or anticoagulant therapy, congenital heart disease, scleroderma). 1 45 46 48 60 Prophylaxis of Thromboembolism Unless contraindicated, administer concomitant anticoagulant therapy to reduce the risk of pulmonary thromboembolism or systemic embolism associated with the permanent indwelling central venous catheter. 1 16 18 23 31 36 47 48 60 Weigh benefits versus risks of anticoagulation, particularly in patients with increased risk of bleeding. 1 48 (See Hematologic Effects under Cautions.) Dosage Titration Dosage adjustments during long-term use should be made immediately upon occurrence of dose-limiting adverse effects or worsening of symptoms associated with pulmonary hypertension. 1 60 Following dosage adjustments, standing and supine BP and heart rate should be monitored closely for several hours. 1 60 (See Dosage and Administration.) Aggressive dosage titrations to overcome tachyphylaxis may result in elevated cardiac output and/or high output heart failure. 47 48 Monitor PAH symptoms, exercise capacity, adverse effects, and hemodynamic function frequently when making dosage adjustments. 1 47 48 60 Some experts recommend that periodic cardiac catheterizations be considered to prevent underdosing or overdosing of drug. 47 48 Weigh risks versus benefits of cardiac catheterization. 1 60 Specific Populations Pregnancy Category B. 1 60 Safety and efficacy during labor, vaginal delivery, or cesarean section have not been established. 1 60 Lactation Not known whether epoprostenol is distributed into milk; use with caution in nursing women. 1 60 Pediatric Use Safety and efficacy not established in pediatric patients. 1 43 60 Geriatric Use Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. 1 60 Common Adverse Effects Patients with idiopathic or heritable PAH: 1 60 61 dizziness, 1 2 60 61 headache, 1 2 5 7 8 9 10 11 12 18 20 60 61 nausea, 1 2 6 8 9 10 11 20 60 61 vomiting, 1 2 5 9 11 20 60 61 jaw pain, 1 5 6 7 8 9 10 11 12 18 20 60 61 myalgia, 1 60 61 flushing, 1 2 5 7 8 9 10 18 20 60 61 diarrhea, 1 5 6 7 8 9 10 11 12 60 61 tachycardia, 1 2 60 nonspecific musculoskeletal pain, 1 2 10 11 12 18 20 60 chills/fever/sepsis/flu-like symptoms, 1 60 61 anxiety/nervousness/tremor, 1 60 61 hypoesthesia/hyperesthesia/paresthesia. 1 60 61 Patients with PAH associated with the scleroderma spectrum of diseases: pain/neck pain/arthralgia, 1 60 61 jaw pain, 1 60 61 anorexia, 1 60 61 diarrhea, 1 60 61 headache, 1 60 61 nausea/vomiting, 1 60 61 skin ulcer, 1 60 61 eczema/rash/urticaria, 1 60 61 flushing, 1 60 61 hypotension. 1 60 61 Interactions for Epoprostenol Sodium In clinical studies, epoprostenol was used concomitantly with digoxin, diuretics, anticoagulants, oral vasodilators, and supplemental oxygen. 1 5 6 7 19 20 60 61 Specific Drugs Drug Interaction Comments Anticoagulants Potential for increased risk of bleeding 1 60 61 Antiplatelet agents Potential for increased risk of bleeding 1 60 61 Digoxin Potential decreased clearance of digoxin; possible digoxin toxicity 1 60 61 Clinically important elevations in digoxin concentration may occur upon initiation of epoprostenol therapy in patients prone to digoxin toxicity 1 60 61 Diuretics Potential decreased clearance of furosemide 1 60 61 Possible additive hypotensive effect 1 60 61 Changes in furosemide clearance not considered clinically important 1 60 61 Hypotensive agents Possible additive hypotensive effect 1 60 61 Vasodilators Possible additive hypotensive effect 1 60 61 Epoprostenol Sodium Pharmacokinetics Chemical assays with sufficient sensitivity and specificity to assess the in vivo pharmacokinetics of epoprostenol in humans not currently available. 1 60 61 Distribution Extent Animal studies indicate a small volume of distribution (357 mL/kg). 1 60 61 Elimination Metabolism Rapidly hydrolyzed at neutral pH in blood and also subject to enzymatic degradation. 1 2 60 61 Metabolized to 2 primary metabolites, 6-keto-PGF 1α (formed by spontaneous degradation) and 6,15-diketo-13,14-dihydro-PGF 1α (enzymatically formed); data in animals indicate that both metabolites have pharmacologic activity orders of magnitude less than parent drug. 1 2 60 61 Extensively metabolized; 14 additional minor metabolites isolated from urine. 1 60 61 Elimination Route 82% in urine and 4% in feces. 1 2 60 61 Half-life In vitro, approximately 6 minutes in human blood at 37 C and pH 7.4; in vivo, expected to be 6 minutes. 1 2 10 60 61 2.7 minutes (animals). 1 60 61 Special Populations No gender difference observed in in vitro (human plasma) half-life based on inhibition of platelet aggregation. 1 60 61 Stability Storage Parenteral Powder for Injection Flolan : 15 25 C in original carton; protect from light. 1 Store Sterile Diluent for Flolan at 15 25 C; do not freeze. 1 Epoprostenol sodium injection (generic by Teva): 15 30 C in original carton; protect from light. 61 Store diluent for epoprostenol sodium for injection at 20 25 C; do not freeze. 61 Veletri : 20 25 C in original carton; protect from light. 60 Single-use vials; discard unused portions. 60 Reconstituted solutions of Flolan and epoprostenol sodium (generic by Teva): Store at 2 8 C for 48 hours; protect from light and do not freeze. 1 61 Discard solutions if frozen or stored at 2 8 C for >48 hours. 1 (See Reconstitution and Dilution under Dosage and Administration.) Reconstituted solutions of Veletri : Store at 2 8 C for 8 days if not used immediately. 60 Protect from direct sunlight. 60 Stability of reconstituted solutions of Veletri is temperature and concentration dependent. 60 64 65 (See Reconstitution and Dilution under Dosage and Administration.) Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Drug and Solution Compatibility Do not dilute or administer with other parenteral solutions or drugs. 1 60 61 Actions Direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation. 1 2 10 60 61 May have antiproliferative effects on the intimal layer of precapillary arteries. 2 5 8 9 11 12 18 19 20 22 25 26 27 31 32 35 41 Produces dose-related increases in cardiac index and stroke volume. 1 2 41 60 61 Produces dose-related decreases in pulmonary vascular resistance, total pulmonary resistance, and mean systemic arterial pressure. 1 2 41 60 61 Associated with improvement in survival, exercise capacity, and quality of life assessments. 1 2 5 6 47 48 60 61 Effect on heart rate varies with dose in animals; vagally mediated bradycardia at lower doses and reflex tachycardia in response to direct vasodilation and hypotension at higher doses. 1 2 60 61 No major effects on cardiac conduction in animals. 1 60 61 Additional pharmacologic effects observed in animals include bronchodilation, inhibition of gastric acid secretion, and decreased gastric emptying. 1 60 61 Advice to Patients Importance of advising patient that therapy is infused continuously through a permanent indwelling central venous catheter via a portable infusion device and requires sustained commitment to drug reconstitution, drug administration, and care of the permanent central venous catheter. 1 60 61 Importance of advising patient that therapy probably will be needed for prolonged periods, possibly years. 1 60 61 Importance of careful consideration of patient s ability to accept and care for a permanent central venous catheter and infusion device. 1 60 61 Importance of advising patients that abrupt withdrawal or sudden interruptions in drug delivery may result in symptoms associated with rebound pulmonary hypertension (e.g., dyspnea, dizziness, asthenia) and/or death. 1 10 60 61 Importance of advising patient that sterile technique must be adhered to in drug preparation and catheter care to prevent sepsis. 1 60 61 64 Importance of reconstitution only with the appropriate diluent specified by the manufacturer. 1 60 61 Importance of patient informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 1 60 61 Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 60 61 Importance of informing patients of other important precautionary information. 1 60 61 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Epoprostenol sodium for injection is available only through specialty pharmacies. (See Restricted Distribution under Dosage and Administration.) * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Epoprostenol Sodium Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV infusion 0.5 mg (of epoprostenol)* Epoprostenol Sodium for Injection (available with diluent) Flolan (available with diluent) GlaxoSmithKline Veletri Actelion 1.5 mg (of epoprostenol)* Epoprostenol Sodium for Injection (available with diluent) Flolan (available with diluent) GlaxoSmithKline Veletri Actelion AHFS DI Essentials. 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Next Interactions Print this page Add to My Med List More about epoprostenol Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: agents for pulmonary hypertension Consumer resources Epoprostenol Epoprostenol Intravenous (Advanced Reading) Professional resources Epoprostenol (FDA) Epoprostenol (Wolters Kluwer) Other brands: Flolan , Veletri Related treatment guides Pulmonary Hypertension> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Teva Pharmaceuticals USA, Inc. Drug Class Agents for pulmonary hypertension Related Drugs Pulmonary Hypertension sildenafil , tadalafil , Revatio , Adcirca , Letairis , Opsumit , Tracleer , Adempas , bosentan , macitentan , ambrisentan , Tyvaso , iloprost , Flolan , Remodulin , Uptravi , treprostinil , riociguat , epoprostenol , Orenitram , Veletri , Ventavis , selexipag , More... Epoprostenol Rating 2 User Reviews 8.0 /10 2 User Reviews 8.0 Rate it!} } matches
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