Applies to ibutilide: parenteral solution for injection.
Warning
- May cause potentially fatal arrhythmias.1 7 Should be administered only by skilled personnel in a setting in which proper equipment (e.g., cardiac monitors, intracardiac pacing, cardioverter/defibrillator) and therapy for sustained VT are available during and after drug administration.1 (See Arrhythmogenic Effects under Cautions.)
- Adequate anticoagulation recommended for patients with atrial fibrillation of more than 2–3 days’ duration.1
- Select patients carefully such that the expected benefits of conversion to sinus rhythm outweigh the immediate risks of ibutilide therapy.1 Use ibutilide when it is likely to offer an advantage compared with alternative management methods for atrial flutter or fibrillation.1 (See Supraventricular Tachyarrhythmias under Uses.)
Side effects include:
Generally well tolerated. Adverse events affecting the cardiovascular system (e.g., arrhythmogenic affects, affects on cardiac conduction, palpitation, hypotension, hypertension), nausea, and headache reported in ≤5.1% of patients.
For Healthcare Professionals
Applies to ibutilide: intravenous solution.
General
The most common adverse reactions were ventricular extrasystoles, non-sustained monomorphic ventricular tachycardia, headache, and non-sustained polymorphic ventricular tachycardia.[Ref]
Cardiovascular
Common (1% to 10%): Sustained polymorphic ventricular tachycardia, non-sustained polymorphic ventricular tachycardia, non-sustained monomorphic ventricular tachycardia, atrioventricular block, bundle branch block, ventricular extrasystoles, hypotension/postural hypotension, bradycardia/sinus bradycardia, tachycardia/sinus tachycardia/supraventricular tachycardia, hypertension, QT segment prolonged, palpitation, tachycardia
Uncommon (0.1% to 1%): Sustained monomorphic ventricular tachycardia, supraventricular extrasystoles, nodal arrhythmia, congestive heart failure, idioventricular rhythm[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Syncope[Ref]
Gastrointestinal
Common (1% to 10%): Nausea[Ref]
Renal
Uncommon (0.1% to 1%): Renal failure[Ref]
