Ibutilide

IV Compatibilities

Solution: D5W, NS

IV Preparation

Dilute in 50 mL NS or D5W to make 0.017 mg/mL solution

IV Administration

IV infusion over 10 min diluted or undiluted

Storage

May store diluted soln for 24 hr at room temperature OR 48 hr at 2-8°C (36-46°F)

Ibutilide is an anti-arrhythmic heart medication that corrects certain conditions of irregular heart rhythm.

Ibutilide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Ibutilide is used in people with atrial fibrillation or atrial flutter.

Ibutilide may also be used for purposes not listed in this medication guide.

Ibutilide can cause life-threatening irregular heart rhythms. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG) so that any further problems can be treated quickly.

You should not receive this medication if you are allergic to ibutilide.

If possible, tell your doctor if you have taken a heart rhythm medication within the past 4 hours before receiving ibutilide.

To make sure ibutilide is safe for you, tell your doctor if you have congestive heart failure.

FDA pregnancy category C. It is not known whether ibutilide will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ibutilide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers about your health conditions, or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows you have received this medicine.

You should not receive this medication if you are allergic to ibutilide.

If possible, tell your doctor if you have taken a heart rhythm medication within the past 4 hours before receiving ibutilide.

To make sure ibutilide is safe for you, tell your doctor if you have congestive heart failure.

FDA pregnancy category C. It is not known whether ibutilide will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ibutilide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers about your health conditions, or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows you have received this medicine.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

• Antiarrhythmic Agent, Class III

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]).

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.

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.

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.

• 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.

Less than 60 kg: 0.01 mg/kg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.
60 kg or more: 1 mg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.

Comments:
-In the post-cardiac surgery study, one or two IV infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) were effective in terminating atrial fibrillation or flutter.
-In patients weighing more than 60 kg, a single 2 mg infusion has also been effective in terminating atrial fibrillation or flutter.
-Discontinue infusion upon arrhythmia termination or if sustained or non-sustained ventricular tachycardia or marked QT or QTc prolongation occurs.
-Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.

Data not available

Administration advice:
-Personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia, must administer this drug.
-This drug may be administered undiluted or diluted in 50 mL of diluent.

Storage requirements: Admixtures of this drug with approved diluents remain stable for 24 hours at room temperature and 48 hours at refrigerated temperatures.

Reconstitution/preparation techniques: One 10 mL vial of this drug (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL.

IV compatibility:
-Compatible diluents: 5% dextrose injection; 0.9% sodium chloride injection
-Compatible containers: Polyvinyl chloride plastic bags; Polyolefin bags

General:
-In a trial comparing ibutilide and sotalol, ibutilide 2 mg administered as a single infusion to patients greater than 60 kg was also effective in terminating atrial fibrillation or atrial flutter.
-In the post-cardiac surgery study, one or two 0.005 mg/kg IV infusions for patients weighing less than 60 kg was effective in terminating atrial fibrillation or atrial flutter.

Monitoring:
-Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.
-Patients with abnormal liver function should be monitored by telemetry for more than the 4-hour period generally recommended.