CORVERT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORVERT (CORVERT).
Ibutilide, a class III antiarrhythmic agent, prolongs atrial and ventricular refractoriness by blocking delayed rectifier potassium current (IKr) and activating slow inward sodium current (INa-S).
| Metabolism | Extensively metabolized in the liver via oxidation, primarily by CYP2D6, with minor contributions from other CYP450 enzymes. |
| Excretion | Renal (approximately 82% of total clearance), with about 18% biliary/fecal elimination. Mostly unchanged drug and metabolites. |
| Half-life | Terminal elimination half-life is approximately 6 hours (range 2–12 hours) in patients with normal renal function. Prolonged in renal impairment (up to 16 hours in severe impairment). |
| Protein binding | Approximately 70% bound to plasma proteins (albumin). |
| Volume of Distribution | Volume of distribution is approximately 10 L/kg (range 8–12 L/kg), indicating extensive tissue distribution. |
| Bioavailability | Bioavailability not applicable (administered only intravenously). |
| Onset of Action | Intravenous: Onset of action within minutes; peak effect on QT interval occurs within 10–15 minutes after infusion start. |
| Duration of Action | Duration of action on QT prolongation persists for 4–6 hours after cessation of infusion; clinical effects (e.g., cardioversion) may last longer. |
1 mg intravenously over 10 minutes; repeat once after 10 minutes if conversion to sinus rhythm not achieved. Maximum total dose: 2 mg.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment recommended for renal impairment. Ibutilide is minimally renally excreted. |
| Liver impairment | No specific Child-Pugh based guidelines; use with caution in severe hepatic impairment due to risk of elevated plasma levels. |
| Pediatric use | Not FDA approved for pediatric use. Limited data; weight-based dosing not established. |
| Geriatric use | No specific dose adjustment; elderly may have increased risk of proarrhythmia (e.g., torsades de pointes). Monitor ECG closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORVERT (CORVERT).
| Breastfeeding | It is not known whether ibutilide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CORVERT is administered to a nursing woman. No M/P ratio data available. |
| Teratogenic Risk | FDA Pregnancy Category C. Ibutilide (CORVERT) has not been studied in pregnant women. In animal studies, ibutilide fumarate administered intravenously to rats and rabbits during organogenesis at doses up to 5.8 and 3.8 times the maximum recommended human dose (MRHD) based on body surface area, respectively, produced no evidence of teratogenicity. However, embryotoxicity (increased postimplantation loss) occurred in rats at maternally toxic doses. Because animal reproduction studies are not always predictive of human response, CORVERT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is no known risk of fetal arrhythmias or other specific teratogenic effects associated with ibutilide. |
■ FDA Black Box Warning
Can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia (torsade de pointes), especially in patients with structural heart disease. Must be administered in a setting with continuous ECG monitoring and personnel trained in resuscitation.
| Serious Effects |
["Hypersensitivity to ibutilide","QTc interval >440 msec at baseline","History of polymorphic ventricular tachycardia (e.g., torsade de pointes)"]
| Precautions | ["Risk of ventricular arrhythmias, especially torsade de pointes","Hypokalemia and hypomagnesemia should be corrected before administration","Monitor ECG continuously during and for at least 4 hours after infusion","Use caution in patients with bradycardia, heart block, or impaired left ventricular function"] |
| Food/Dietary | No specific food interactions. Maintain normal electrolyte balance; avoid excessive alcohol or caffeine that may affect heart rhythm. |
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| Fetal Monitoring | Continuous ECG monitoring during and for at least 4 hours after infusion or until QTc returns to baseline; monitor for sustained polymorphic ventricular tachycardia (e.g., torsade de pointes). Monitor plasma potassium and magnesium levels; correct hypokalemia and hypomagnesemia before administration. In pregnancy, monitor maternal heart rate and rhythm, blood pressure, and fetal heart rate via electronic fetal monitoring if clinically indicated. |
| Fertility Effects | No human data on fertility effects. In animal studies, ibutilide had no adverse effects on fertility in rats at intravenous doses up to 3.5 times the MRHD based on body surface area. |
| Clinical Pearls | CORVERT (ibutilide fumarate) is a Class III antiarrhythmic used for acute conversion of atrial fibrillation/flutter. Monitor QT interval closely due to risk of torsades de pointes; have defibrillator and magnesium/potassium replacement ready. Correct hypokalemia and hypomagnesemia before administration. Infusion must be stopped if arrhythmia converts or if ventricular tachycardia occurs. Post-conversion monitoring for at least 4 hours is mandatory. |
| Patient Advice | This medication is given intravenously to convert your irregular heart rhythm to normal. · You will be closely monitored with an ECG and vital signs during and after infusion. · Report any symptoms like dizziness, palpitations, or fainting immediately. · Avoid driving or operating machinery until cleared by your healthcare provider. · Inform your doctor of all medications you take, especially other heart medications. |