(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
Exact mechanism of action is unknown; prolongs the action potential in cardiac tissue
Extensively hepatic; oxidation
Urine (82%; 7% as unchanged drug and metabolites); feces (19%)
Onset of Action
~90 minutes after start of infusion (1/2 of conversions to sinus rhythm occur during infusion)
2-12 hours (average: 6 hours)
Use: Labeled Indications
Acute termination of atrial fibrillation or flutter of recent onset; the effectiveness of ibutilide 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]).
Hypersensitivity to ibutilide or any component of the formulation; QTc >440 msec
Atrial fibrillation/flutter: IV:
<60 kg: 0.01 mg/kg over 10 minutes
≥60 kg: 1 mg over 10 minutes
Note: Discontinue infusion if 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 infusion of equal strength may be infused over a 10-minute period.
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).
Infuse undiluted or diluted over 10 minutes. Observe patient with continuous ECG monitoring for at least 4 hours (>4 hours in patients with abnormal hepatic function) following infusion or until QTc has returned to baseline. Skilled personnel and proper equipment should be available during administration of ibutilide and subsequent monitoring of the patient.
Admixtures are chemically and physically stable for 24 hours at room temperature and for 48 hours at refrigerated temperatures.
Fingolimod: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Avoid combination
Highest Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Highest Risk QTc-Prolonging Agents. Avoid combination
Indapamide: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Consider therapy modification
Ivabradine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination
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
MiFEPRIStone: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination
Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. 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 (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. 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
Vinflunine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination
1% to 10%:
Cardiovascular: Ventricular extrasystoles (5.1%), nonsustained monomorphic ventricular tachycardia (4.9%), nonsustained polymorphic ventricular tachycardia (2.7%), tachycardia/supraventricular tachycardia (2.7%), hypotension (2%), bundle branch block (1.9%), sustained polymorphic ventricular tachycardia (eg, torsade de pointes) (1.7%, often requiring cardioversion), AV block (1.5%), bradycardia (1.2%), QT segment prolongation, hypertension (1.2%), palpitation (1%)
Central nervous system: Headache (4%)
Gastrointestinal: Nausea (>1%)
<1% (Limited to important or life-threatening): CHF, erythematous bullous lesions, idioventricular rhythm, nodal arrhythmia, renal failure, supraventricular extrasystoles, sustained monomorphic ventricular tachycardia, syncope (0.3%, not > placebo)
Concerns related to adverse effects:
• Conduction disturbances: Monitor for heart block.
• Proarrhythmic effects: [U.S. Boxed Warning]: Potentially fatal arrhythmias (eg, polymorphic ventricular tachycardia) can occur with ibutilide, usually in association with torsade de pointes (QT prolongation). Studies indicate a 1.7% incidence of arrhythmias in treated patients. 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).
• Arrhythmias: Appropriate use: The drug should be given in a setting of continuous ECG monitoring and by personnel trained in treating arrhythmias particularly polymorphic ventricular tachycardia.
• Chronic atrial fibrillation: [U.S. 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.
• Electrolyte imbalance: Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy.
• Hepatic impairment: Dosing adjustments are not required in patients with hepatic impairment.
• Renal impairment: Dosing adjustments are not required in patients with renal impairment.
Concurrent drug therapy issues:
• Drugs with QT prolongation potential: Avoid concurrent use with any drug that can prolong QT interval.
• Pediatric: Safety and efficacy have not been established in children.
• 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 following infusion or until QTc has returned to baseline; skilled personnel and proper equipment should be available during administration of ibutilide and subsequent monitoring of the patient
Consult individual institutional policies and procedures.
Pregnancy Risk Factor
Adverse events were observed in animal reproduction studies. 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, arrhythmia, severe 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 healthcare 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.
More about ibutilide
- Other brands: Corvert