(i BYOO ti lide)
- Ibutilide Fumarate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous, as fumarate:
Corvert: 1 mg/10 mL (10 mL)
Generic: 1 mg/10 mL (10 mL)
Brand Names: U.S.
- Antiarrhythmic Agent, Class III
Vaughan Williams class III antiarrhythmic agent that prolongs myocardial action potential duration (APD) and increases atrial and ventricular refractoriness primarily by activation of a slow inward sodium current (INa-s), in contrast to other agents in this class. Ibutilide also delays repolarization by inhibiting the rapid component of the delayed rectifier potassium current (IKr), though the relative contribution of this mechanism to the antiarrhythmic activity of ibutilide is not known (Cimini 1992; Foster 1997; Lee 1992; Yang 1995).
Vdss: ~11 L/kg
Extensively hepatic; 8 metabolites via oxidation (only 1 active metabolite)
Urine (~82%; ~7% unchanged); feces (~19%)
Onset of Action
Conversion to sinus rhythm: ≤90 minutes after start of infusion
~6 hours (range: 2 to 12 hours)
Use: Labeled Indications
Atrial fibrillation/flutter: Rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm (effectiveness has not been determined in patients with arrhythmias >90 days in duration).
Note: According to the American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines for the management of atrial fibrillation, in patients with pre-excited atrial fibrillation and rapid ventricular response who are not hemodynamically compromised, the use of ibutilide to restore sinus rhythm or slow the ventricular rate is recommended (AHA/ACC/HRS [January, 2014]).
Off Label Uses
Facilitation of transthoracic electrical cardioversion for atrial fibrillation
Data from a randomized open label trial in patients with atrial fibrillation lasting more than 6 hours who were to undergo transthoracic electrical cardioversion administered pretreatment with ibutilide supports the use of ibutilide to facilitate transthoracic electrical cardioversion of atrial fibrillation [Oral 1999]. Additional trials may be necessary to further define the role of ibutilide in this setting.
Postoperative atrial fibrillation
Data from a randomized, double-blind, placebo-controlled trial in patients with post-cardiac surgery atrial fibrillation or atrial flutter supports the use of ibutilide in the treatment of patients with these postoperative arrhythmias [VanderLugt 1999]. Additional trials may be necessary to further define the role of ibutilide in this setting.
Based on the American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline for the Management of Patients with Atrial Fibrillation, it is reasonable to restore sinus rhythm using ibutilide in patients with postoperative atrial fibrillation.
Hypersensitivity to ibutilide or any component of the formulation
Atrial fibrillation/flutter: IV:
<60 kg: 0.01 mg/kg over 10 minutes
≥60 kg: 1 mg over 10 minutes
Note: Discontinue as soon as arrhythmia terminates, if sustained or nonsustained ventricular tachycardia occurs, or if marked prolongation of QT/QTc occurs. If the arrhythmia does not terminate within 10 minutes after the end of the initial infusion, a second 10-minute infusion of equal strength may be infused 10 minutes after completion of the initial infusion.
Refer to adult dosing. Dose selection should be cautious, usually starting at the lower end of the dosing range.
Dosing: Renal Impairment
No dosage adjustment necessary.
Dosing: Hepatic Impairment
No dosage adjustment necessary.
No dilution required. May dilute in 50 mL diluent (0.9% NS or D5W).
IV: Infuse undiluted or diluted over 10 minutes.
Store at 20°C to 25°C (68°F to 77°F). Admixtures stable for 24 hours at room temperature and for 48 hours at refrigerated temperatures.
Amifampridine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Bilastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy
Buprenorphine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy
Fingolimod: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Avoid combination
Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Indapamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Consider therapy modification
Lidocaine (Topical): May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Antiarrhythmic Agents (Class III) may increase the serum concentration of Lidocaine (Topical). This mechanism specifically applies to amiodarone and dronedarone. Monitor therapy
Macimorelin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Mizolastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Propafenone: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Management: Concurrent use of propafenone with quinidine, amiodarone, or other class IA or class III antiarrhythmics should be avoided. Treatment with such agents should be withheld for at least 5 half-lives prior to initiation of propafenone. Avoid combination
QTc-Prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Highest Risk). Avoid combination
QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Teneligliptin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy
Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
Xipamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy
1% to 10%:
Cardiovascular: Nonsustained monomorphic ventricular tachycardia (5%), ventricular premature contractions (5), unsustained polymorphic ventricular tachycardia (3%), supraventricular tachycardia (≤3%), tachycardia (≤3%), atrioventricular block (2%), bundle branch block (2%), hypotension (2%), sustained polymorphic ventricular tachycardia (2%; eg, torsade de pointes; often requiring cardioversion), bradycardia (1%), hypertension (1%), palpitations (1%), prolonged Q-T interval on ECG (1%)
Central nervous system: Headache (4%)
Gastrointestinal: Nausea (>1%)
<1% (Limited to important or life-threatening): Bullous rash (erythematous), cardiac failure, idioventricular rhythm, nodal arrhythmia, renal failure, supraventricular extrasystole, sustained monomorphic ventricular tachycardia
Concerns related to adverse effects:
• Proarrhythmic effects: [US Boxed Warning]: Potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia can occur, usually in association with torsades des pointes (QT prolongation), but sometimes without documented QT prolongation. Studies indicate a 1.7% incidence of arrhythmias in treated patients. 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. Patients with atrial fibrillation of more than 2 to 3 days' duration must be adequately anticoagulated, generally for at least 2 weeks. The use of intravenous magnesium (2 g) immediately prior to and after ibutilide administration has been shown to be helpful in reducing QT interval prolongation due to ibutilide (Caron 2003) and may enhance the efficacy of ibutilide (Kalus 2003). Whether or not prophylactic magnesium reduces the incidence of TdP has yet to be determined; however, it is thought that this measure will reduce the incidence of TdP (Coleman 2004). Consider avoiding use in patients with QTc intervals >440 msec. Use is not recommended in patients who have previously demonstrated polymorphic ventricular tachycardia (eg, torsades de pointes).
• Chronic atrial fibrillation: [US Boxed Warning]: Patients with chronic atrial fibrillation may not be the best candidates for ibutilide since they often revert after conversion and the risks of treatment may not be justified when compared to alternative management. Patients to be treated with ibutilide should be carefully selected such that the expected benefits outweigh the immediate risks.
• Electrolyte imbalance: Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• CAST trial: In the Cardiac Arrhythmia Suppression Trial (CAST), recent (>6 days but <2 years ago) myocardial infarction patients with asymptomatic, non-life-threatening ventricular arrhythmias did not benefit and may have been harmed by attempts to suppress the arrhythmia with flecainide or encainide. An increased mortality or nonfatal cardiac arrest rate (7.7%) was seen in the active treatment group compared with patients in the placebo group (3%). The applicability of the CAST results to other populations is unknown. Antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.
Electrolytes; observe patient with continuous ECG monitoring for at least 4 hours (>4 hours in patients with abnormal hepatic function or if arrhythmic activity is noted) following infusion or until QTc has returned to baseline; skilled personnel and proper equipment should be available during administration and subsequent monitoring
Consult individual institutional policies and procedures.
Use in pregnancy may be considered (ESG [Regitz-Zagrosek 2011]); however, information related to the use of ibutilide in pregnancy is limited (Burkart 2007; Kockova 2007).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber angina, bradycardia, tachycardia, abnormal heartbeat, dizziness, or passing out (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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- Drug class: group III antiarrhythmics
Other brands: Corvert