NEXTERONE® (amiodarone HCl) Injection is a novel, patent-protected, cosolvent-free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone® Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

NEXTERONE has been developed to overcome the practical limitations associated with the use of Amiodarone IV which stem from the presence of cosolvents (polysorbate 80 and benzyl alcohol) while preserving its beneficial effects as an antiarrhythmic agent. NEXTERONE is being developed in ready-to-use premixed bags and a pre-filled syringe to address medication management issues in the hospital environment.

NEXTERONE is being manufactured through relationships with Baxter Healthcare Corporation, HollisterStier Laboratories LLC, and CyDex Pharmaceuticals, Inc.

Important Safety Information About NEXTERONE
The most important treatment-emergent adverse effects associated with intravenous amiodarone therapy in clinical studies were hypotension, asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, ventricular tachycardia, and atrioventricular block. Overall, treatment was discontinued for about 9 percent of the patients because of adverse effects. The most common adverse effects leading to discontinuation of intravenous amiodarone therapy were hypotension (1.6 percent), asystole/cardiac arrest/EMD (1.2 percent), ventricular tachycardia (1.1 percent), and cardiogenic shock (1 percent).

NEXTERONE is contraindicated in patients with known hypersensitivity to any of the components of NEXTERONE, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV block unless a functioning pacemaker is available.

NEXTERONE is for hospital use only. NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of intravenous amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.

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Prism licenses Captisol®-enabled Amiodarone IV from CyDex Pharmaceuticals, Inc.