Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
epoprostenol (UNII: DCR9Z582X0) (epoprostenol - UNII:DCR9Z582X0)
Actelion Pharmaceuticals US, Inc.
epoprostenol
epoprostenol 500000 ng in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. A large study evaluating the effect of epoprostenol on survival in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving epoprostenol plus conventional therapy than in those receiving conventional therapy alone. The chronic use of VELETRI in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated. Some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with pulmonary veno-occlusive disease. VELE
VELETRI is supplied as a sterile lyophilized material in 10 mL vials. 10 mL vial with a white flip-off seal containing epoprostenol sodium equivalent to 0.5 mg (500,000 ng) epoprostenol, is packaged in carton of 1 vial (NDC 66215-403-01). 10 mL vial with a red flip-off seal containing epoprostenol sodium equivalent to 1.5 mg (1,500,000 ng) epoprostenol, is packaged in carton of 1 vial (NDC 66215-402-01). Store the vials of VELETRI at 68° to 77°F (20° to 25°C) [see USP Controlled Room Temperature] . Unopened vials of VELETRI are stable until the date indicated on the package when stored at 68° to 77°F (20° to 25°C). The unopened vial should be kept in the carton and not exposed to direct sunlight. Use after reconstitution and immediate dilution to final concentration can be found in Dosage and Administration (2.4) Reconstitution, Table 1: Maximum duration of administration (hours) at room temperature (77°F/25°C) of fully diluted solutions in the drug delivery reservoir. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. If either occurs, do not administer.
New Drug Application
VELETRI- EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ACTELION PHARMACEUTICALS US, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VELETRI SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VELETRI. VELETRI (EPOPROSTENOL) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE VELETRI is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. (1) DOSAGE AND ADMINISTRATION Dosage - - Administration - - Reconstitution - - - DOSAGE FORMS AND STRENGTHS Injection: 10 mL single-dose vial with 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) VELETRI. (3) CONTRAINDICATIONS Congestive heart failure due to severe left ventricular systolic dysfunction (4) Pulmonary edema (4) Hypersensitivity to the drug or to structurally related compounds (4) WARNINGS AND PRECAUTIONS Do not abruptly lower the dose or withdraw dosing. All dosing initiation and changes should be closely monitored. (5.2, 5.3) ADVERSE REACTIONS Most common adverse reactions during: - - ® Infusion of VELETRI should be initiated at 2 ng/kg/min and increased in increments of 2 ng/kg/min every 15 minutes or longer until dose-limiting pharmacologic effects are elicited or until a tolerance limit to the drug is established. (2.1) If symptoms of pulmonary hypertension persist or recur after improving - the infusion should be increased by 1- to 2-ng/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be at least 15 minutes. (2.2) VELETRI is administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump. (2.3) Do not mix with any other parenteral medications or Lugege kogu dokumenti