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Ibutilide

Pronunciation

(i BYOO ti lide)

Index Terms

  • Ibutilide Fumarate

Dosage Forms

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.

  • Corvert

Pharmacologic Category

  • Antiarrhythmic Agent, Class III

Pharmacology

Exact mechanism of action is unknown; prolongs the action potential in cardiac tissue

Distribution

Vdss: ~11 L/kg

Metabolism

Extensively hepatic; 8 metabolites via oxidation (only 1 active metabolite)

Excretion

Urine (~82%; ~7% unchanged); feces (~19%)

Onset of Action

Conversion to sinus rhythm: ≤90 minutes after start of infusion

Half-Life Elimination

~6 hours (range: 2 to 12 hours)

Protein Binding

~40%

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]).

Contraindications

Hypersensitivity to ibutilide or any component of the formulation

Dosing: Adult

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.

Dosing: Geriatric

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.

Reconstitution

No dilution required. May dilute in 50 mL diluent (0.9% NS or D5W).

Administration

Infuse undiluted or diluted over 10 minutes.

Storage

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.

Drug Interactions

Bilastine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Monitor therapy

Buprenorphine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Monitor therapy

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

Hydroxychloroquine: May enhance the QTc-prolonging effect of 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

Probucol: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Promazine: 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

Teneligliptin: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Monitor therapy

Vinflunine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Xipamide: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Monitor therapy

Adverse Reactions

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

ALERT: U.S. Boxed Warning

Life-threatening arrhythmias:

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

Appropriate treatment environment:

Choice of patients: 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, therefore, 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 are likely to offer an advantage compared with alternative management.

Warnings/Precautions

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).

Disease-related concerns:

• 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.

Other warnings/precautions:

• 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.

Monitoring Parameters

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.

Pregnancy Considerations

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).

Patient Education

• 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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