Corvert Side Effects

Please note - some side effects for Corvert may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Corvert - for the Consumer

Corvert

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Corvert:

Dizziness; headache; nausea; rapid heartbeat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; heart block; heart failure; shortness of breath; swelling of feet or ankles; worsening of heart rhythm problems.

Corvert Side Effects - for the Professional

Corvert

Corvert Injection was generally well tolerated in clinical trials. Of the 586 patients with atrial fibrillation or atrial flutter who received Corvert 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 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 than in the placebo group.

Another adverse reaction that may be associated with the administration of Corvert 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.

In the post-cardiac surgery study, 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.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects were experienced by 25% of 586 patients in clinical trials. Like many other antiarrhythmic agents, ibutilide is potentially proarrhythmic. Ibutilide can induce sustained polymorphic ventricular tachycardia (VT) in 1.7% to 8.3% and nonsustained polymorphic VT in 1.7% to 2.7% of patients. Sustained monomorphic VT (0.2%), bundle branch block (1.9%), ventricular extrasystoles (5.1%), supraventricular extrasystoles (0.9%), hypotension or postural hypotension (2.0%), bradycardia or sinus bradycardia (1.2%), nodal arrhythmia (0.7%), congestive heart failure (0.5%), tachycardia or sinus tachycardia or supraventricular tachycardia in (2.7%), idioventricular rhythm (0.2%), hypertension (1.2%), QT segment prolongation in (1.2%), and syncope (0.3%) have been reported in patients receiving ibutilide therapy. The incidence of these events, except for syncope, was greater in treated patients compared with placebo.

Ibutilide can cause potentially fatal arrhythmias, particular sustained polymorphic ventricular tachycardia (VT), usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In clinical studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during or within a number of hours of use of ibutilide. These arrhythmias can be reversed if treated promptly. It is essential that ibutilide be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic VT.

Patients with atrial fibrillation of more than 2 to 3 days' duration must be adequately anticoagulated, generally for at least 2 weeks.

Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm and treatments to maintain sinus rhythm carry risks. Patients to be treated with ibutilide should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of ibutilide and the risks of maintenance therapy, and benefits are likely to offer an advantage compared with alternative management.

Gastrointestinal

Gastrointestinal side effects appear limited to nausea in 1.9% of patients (compared with 0.8% with placebo).

Nervous system

Nervous system side effects include headache in 3.6% of patients (compared with 3.1% with placebo).

Renal

Renal failure has been reported in 0.3% of patients. A causal relationship has not been established.

Dermatologic

Dermatologic side effects including a case of dermatologic erythematous bullous lesions due to contact with ibutilide has been reported. Ibutilide fumarate contains a methanesulfonamide moiety.

A medical student exposed to a 10 mL spill of ibutilide (0.017 mg/mL in 5% dextrose) immediately towel dried the exposed hands. Several hours elapsed before the hands were washed in soap and water. Six to eight hours postexposure the student noted a tingling and burning sensation on the hands and at 18 hours the areas of hand exposed to ibutilide were erythematous and red, with 2 bullous lesions on each hand. A single dose of topical betamethasone (0.05%) was applied and the areas were kept clean and dry. Resolution occurred after approximately 10 days. Rechallenge was refused.

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