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CORVERT (ibutilide fumarate injection) Injection was generally well tolerated in clinical trials. Of the 586 patients with atrial fibrillation or atrial flutter who received CORVERT (ibutilide fumarate injection) in phase II/III studies, 149 (25%) reported medical events related to the cardiovascular system, including sustained polymorphic ventricular tachycardia (1.7%) and nonsustained polymorphic ventricular tachycardia (2.7%).
Other clinically important adverse events with an uncertain relationship to CORVERT (ibutilide fumarate injection) include the following (0.2% represents one patient): sustained monomorphic ventricular tachycardia (0.2%), nonsustained monomorphic ventricular tachycardia (4.9%), AV block (1.5%), bundle branch block (1.9%), ventricular extrasystoles (5.1%), supraventricular extrasystoles (0.9%), hypotension/postural hypotension (2.0%), bradycardia/sinus bradycardia (1.2%), nodal arrhythmia (0.7%), congestive heart failure (0.5%), tachycardia/sinus tachycardia/supraventricular tachycardia (2.7%), idioventricular rhythm (0.2%), syncope (0.3%), and renal failure (0.3%). The incidence of these events, except for syncope, was greater in the group treated with CORVERT (ibutilide fumarate injection) than in the placebo group.
Another adverse reaction that may be associated with the administration of CORVERT (ibutilide fumarate injection) was nausea, which occurred with a frequency greater than 1% more in ibutilide-treated patients than those treated with placebo.
The medical events reported for more than 1% of the placebo- and ibutilide-treated patients are shown in the following Table.
Treatment-Emergent Medical Events With Frequency of More
Than 1% and Higher Than That of Placebo
|Nonsustained monomorphic VT||1||0.8||29||4.9|
|Nonsustained polymorphic VT||-||-||16||2.7|
|Bundle branch block||-||-||11||1.9|
|Sustained polymorphic VT||-||-||10||1.7|
|QT segment prolonged||-||-||7||1.2|
|CENTRAL NERVOUS SYSTEM|
In the post-cardiac surgery study (see Clinical Studies), similar types of medical events were reported. In the 1 mg ibutilide fumarate treatment group (N=70), 2 patients (2.9%) developed sustained polymorphic ventricular tachycardia and 2 other patients (2.9%) developed nonsustained polymorphic ventricular tachycardia. Polymorphic ventricular tachycardia was not reported in the 73 patients in the 0.5 mg dose group or in the 75 patients in the 0.25 mg dose group.
No specific pharmacokinetic or other formal drug interaction studies were conducted.
Digoxin: Supraventricular arrhythmias may mask the cardiotoxicity associated with excessive digoxin levels. Therefore, it is advisable to be particularly cautious in patients whose plasma digoxin levels are above or suspected to be above the usual therapeutic range. Coadministration of digoxin did not have effects on either the safety or efficacy of ibutilide in the clinical trials.
Calcium channel blocking agents: Coadministration of calcium channel blockers did not have any effect on either the safety or efficacy of ibutilide in the clinical trials.
Beta-adrenergic blocking agents: Coadministration of beta-adrenergic blocking agents did not have any effect on either the safety or efficacy of ibutilide in the clinical trials.
Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.
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