LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT
CORVERT 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. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia). It is essential that CORVERT 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, therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of CORVERT, and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.
|
| |
CORVERT SUMMARY
Corvert®
ibutilide fumarate injection
CORVERT Injection (ibutilide fumarate injection) is an antiarrhythmic drug with predominantly class III (cardiac action potential prolongation) properties according to the Vaughan Williams Classification. Each milliliter of CORVERT Injection contains 0.1 mg of ibutilide fumarate (equivalent to 0.087 mg ibutilide free base), 0.189 mg sodium acetate trihydrate, 8.90 mg sodium chloride, hydrochloric acid to adjust pH to approximately 4.6, and Water for Injection. CORVERT Injection is an isotonic, clear, colorless, sterile aqueous solution. Ibutilide fumarate has one chiral center, and exists as a racemate of the (+) and (−) enantiomers.
CORVERT 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. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Corvert (Ibutilide)
The Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
(MAGIC-AF) Study: clinical background and study design. [2012]
complication rate... CONCLUSION: The MAGIC-AF study will assess the utility of a combined
Pre-injection of magnesium sulfate enhances the efficacy of ibutilide for the conversion of typical but not of atypical persistent atrial flutter. [2010.06.11]
BACKGROUND: Ibutilide is a class III antiarrhythmic drug, frequently used for conversion of atrial fibrillation and flutter. Retrospective cohort evaluations found that intravenous application of magnesium enhances the efficacy of ibutilide for chemical conversion of these arrhythmias. This prospective study sought to investigate the effects of intravenously pre-injected magnesium on the conversion rate of ibutilide for typical and atypical atrial flutter... CONCLUSIONS: Pre-injection of magnesium significantly enhances the efficacy of ibutilide for the conversion of TAF but not of AAF. Copyright (c) 2008 Elsevier Ireland Ltd. All rights reserved.
Propafenone added to ibutilide increases conversion rates of persistent atrial fibrillation. [2006.05]
CONCLUSION: Concurrent administration of propafenone plus ibutilide for pharmacological cardioversion of persistent AF is safe and more effective than ibutilide alone.
Is pretreatment with ibutilide useful for atrial fibrillation cardioversion when combined with biphasic shock? [2006.02]
OBJECTIVE: Cardioversion of atrial fibrillation by means of a monophasic transthoracic shock is facilitated by pretreatment with ibutilide. The aim of this study was to randomly and prospectively compare the energy requirements of transthoracic biphasic cardioversion of atrial fibrillation with and without ibutilide pretreatment... CONCLUSIONS: Although not essential for a successful outcome, pretreatment with ibutilide can lower energy requirements in transthoracic biphasic cardioversion.
Comparison of intravenous ibutilide vs. propafenone for rapid termination of recent onset atrial fibrillation. [2005.12]
This study was to evaluate the efficacy and safety of ibutilide and propafenone given intravenously in converting recent onset atrial fibrillation (AF). Eighty-two consecutive patients with AF (onset in 2 h to 90 days) were randomly assigned to receive two 10-min infusions, 10 min apart, of either ibutilide (1 mg) or propafenone (70 mg).
Clinical Trials Related to Corvert (Ibutilide)
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation [Recruiting]
Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30
million North Americans and Europeans by 2050. Atrial fibrillation is associated with
increased cardiovascular morbidity and mortality, with stroke being an especially important
and potentially devastating complication. Many studies have investigated the efficacy of
different drugs in converting atrial fibrillation to sinus rhythm. There are numerous
randomized controlled trials that have tested the efficacy of agents against placebo and
some trials that directly compared the efficacy of two or more different drugs. The class
III antiarrhythmic drug Ibutilde is approved for the acute termination of atrial
fibrillation and atrial flutter of recent onset and has been shown to be superior to sotalol
and equivalent to flecainide in this indication. Recently, the relatively atrial selective
antiarrhythmic agent vernakalant has been approved by the European Commission for the rapid
conversion of recent onset AF to sinus rhythm in adults. The investigators hypothesize that
the period of time needed for cardioversion to sinus rhythm and the efficacy of
cardioversion within 90 minutes is different between vernakalant and ibutilide in patients
with recent-onset atrial fibrillation.
Ibutilide Administration During Pulmonary Vein Ablation [Recruiting]
To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide
will be administered intravenously in patients undergoing an Afib ablation. The hypothesis
of this study is that ibutilide will decrease the high frequency signals observed in Afib
suggesting the presence of micro reentrant circuits as the basic mechanism of Afib,
especially for the paroxysmal Afib group. The potential difference in response to the
ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the
underlying mechanism of Afib between these two groups.
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation [Recruiting]
Procedures for ablation of persistent or long lasting atrial fibrillation are frequently
long and require extensive ablation. Some electrophysiologists administer the drug
ibutilide during these procedures to help organize the fibrillatory activity of the left
atrium with the hope that this may shorten the length of the procedure and duration of
ablation needed. Currently there is no standardized approach of administering the drug
ibutilide during these procedures, thus the investigators cannot be certain that
administering this drug does in fact facilitate the procedure. The aim of the MAGIC-AF
Trial is to see if administering a standard dose of the drug ibutilide at a standard time in
the procedure can allow for a reduction in the ablation procedure time. The investigators
hypothesize that administering ibutilide during these procedures will result in a reduction
in the procedure and ablation time required.
Reports of Suspected Corvert (Ibutilide) Side Effects
Escherichia Infection (4),
Ventricular Tachycardia (2),
Torsade DE Pointes (1)
|
|
|
|
Page last updated: 2013-02-10
|
