"The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.
This first-of-its-kind use is"...
CORVERT (ibutilide fumarate injection) Injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to CORVERT (ibutilide fumarate injection) . The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.
LIFE-THREATENING ARRHYTHMIAS-APPROPRIATE TREATMENT ENVIRONMENT
CORVERT (ibutilide fumarate injection) can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of CORVERT (ibutilide fumarate injection) . These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia). It is essential that CORVERT (ibutilide fumarate injection) be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. Patients with atrial fibrillation of more than 2 to 3 days' duration must be adequately anticoagulated, generally for at least 2 weeks.
CHOICE OF PATIENTS
Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see Clinical Studies) and treatments to maintain sinus rhythm carry risks. Patients to be treated with CORVERT (ibutilide fumarate injection) , therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of CORVERT (ibutilide fumarate injection) , and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.
DOSAGE AND ADMINISTRATION
The recommended dose based on controlled trials (see Clinical Studies) is outlined in the Table below. Ibutilide infusion should be stopped as soon as the presenting arrhythmia is terminated or in the event of sustained or nonsustained ventricular tachycardia, or marked prolongation of QT or QTc.
Recommended Dose of CORVERT (ibutilide fumarate injection) Injection
|Patient Weight||Initial Infusion (over 10 minutes)||Second Infusion|
|60 kg (132 lb)or more||One vial (1 mg ibutilide fumarate)||If the arrhythmia does not terminate within 10 minutes after the end of the initial infusion, asecond 10-minute infusion ofequal strength may be administered 10 minutes after completion of the first infusion.|
|Less than 60 kg (132 lb)||0.1 mL/kg (0.01 mg/kg ibutilide fumarate)|
In a trial comparing ibutilide and sotalol (see Clinical Studies), 2 mg ibutilide fumarate administered as a single infusion to patients weighing more than 60 kg was also effective in terminating atrial fibrillation or atrial flutter.
In the post-cardiac surgery study (see Clinical Studies), one or two intravenous infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) was effective in terminating atrial fibrillation or atrial flutter.
Patients should be observed with continuous ECG monitoring for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if any arrhythmic activity is noted. Skilled personnel and proper equipment (see WARNINGS, Proarrhythmia), such as a cardioverter/defibrillator, and medication for treatment of sustained ventricular tachycardia, including polymorphic ventricular tachycardia, must be available during administration of CORVERT (ibutilide fumarate injection) and subsequent monitoring of the patient.
Dilution: CORVERT (ibutilide fumarate injection) Injection may be administered undiluted or diluted in 50 mL of diluent. CORVERT (ibutilide fumarate injection) may be added to 0.9% Sodium Chloride Injection or 5% Dextrose Injection before infusion. The contents of one 10 mL vial (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL ibutilide fumarate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Compatibility and Stability: The following diluents are compatible with CORVERT (ibutilide fumarate injection) Injection (0.1 mg/mL):
5% Dextrose Injection
0.9% Sodium Chloride Injection
The following intravenous solution containers are compatible with admixtures of CORVERT (ibutilide fumarate injection) Injection (0.1 mg/mL):
polyvinyl chloride plastic bags
Admixtures of the product, with approved diluents, are chemically and physically stable for 24 hours at room temperature (15° to 30° C or 59° to 86° F) and for 48 hours at refrigerated temperatures (2° to 8°C or 36° to 46°F). Strict adherence to the use of aseptic technique during the preparation of the admixture is recommended in order to maintain sterility.
CORVERT Injection (ibutilide fumarate injection) is supplied as an acetate-buffered isotonic solution at a concentration of 0.1 mg/mL that has been adjusted to approximately pH 4.6 in 10 mL clear glass, single-dose, flip-top vials.
Single-dose 10 mL vial, 1 mg /10 mL (0.1 mg/mL)...................NDC 0009-3794-01
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Store vial in carton until used.
Distributed By Pharmacia and Upjohn Company, A Division of Pfizer Inc., NY, NY 10017. Revised February 2006. FDA Rev date: 10/17/2002This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/25/2008
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