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Ibutilide Fumarate

Also known as: Corvert

Route: Intravenous

1 interaction on record⛔ Black Box Warning

Ibutilide Fumarate has 1 known drug interaction based on U.S. FDA drug labeling data. Notable interactions include combinations with Digoxin. Patients taking Ibutilide Fumarate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 1
Moderate: 1

Moderate (1)

Ibutilide Fumarate + Digoxin— Supraventricular arrhythmias may mask cardiotoxicity from excessive digoxin levels. Use caution in patients with elevate…

Ibutilide Fumarate + Digoxin🟡Moderate

Supraventricular arrhythmias may mask cardiotoxicity from excessive digoxin levels. Use caution in patients with elevated plasma digoxin levels.

⛔ FDA Black Box Warning

LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT CORVERT 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, use of CORVERT. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia ). It is essential that CORVERT 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. CHOICE OF PATIENTS Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see CLINICAL STUDIES ) and treatments to maintain sinus rhythm carry risks. Patients to be treated with CORVERT, therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of CORVERT, and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.

Contraindications

CONTRAINDICATIONS Ibutilide fumarate injection is contraindicated in patients who have previously demonstrated hypersensitivity to ibutilide fumarate or any of the other product components.

Pregnancy & Breastfeeding

Pregnancy Ibutilide administered orally was teratogenic (abnormalities included adactyly, interventricular septal defects, and scoliosis) and embryocidal in reproduction studies in rats. On a mg/m 2 basis, corrected for the 3% oral bioavailability, the “no adverse effect dose” (5 mg/kg/day given orally) was approximately the same as the maximum recommended human dose (MRHD); the teratogenic dose (20 mg/kg/day given orally) was about four times the MRHD on a mg/m 2 basis, or 16 times the MRHD on a mg/kg basis. Ibutilide fumarate should not be administered to a pregnant woman unless clinical benefit outweighs potential risk to the fetus.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.