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NEXTERONE (amiodarone HCl) Premixed Injection Indications and Important Risk Information (IRI)

Indications and Usage

NEXTERONE (amiodarone HCl) Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy.

Important Risk Information (IRI)

NEXTERONE (amiodarone HCl) Premixed Injection 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 amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.

NEXTERONE is contraindicated in patients with:

  • Known hypersensitivity to any of the components of NEXTERONE, including iodine
  • Cardiogenic shock
  • Marked sinus bradycardia
  • Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available
  • Hypotension is the most common adverse reaction seen with intravenous amiodarone. Clinically significant hypotension was seen most often in the first several hours of treatment and appeared to be related to the rate of infusion. To treat hypotension, slow the infusion; as needed, add vasopressor drugs, positive inotropic agents, and volume expansion.
  • Drug-related bradycardia that was not dose‐related occurred while patients were receiving intravenous amiodarone for life-threatening VT/VF. To treat bradycardia, slow the infusion or discontinue NEXTERONE. In some patients, inserting a pacemaker is required.
  • Carefully monitor patients receiving NEXTERONE for evidence of progressive hepatic injury. In such cases, consider reducing the rate of administration or withdrawing NEXTERONE.
  • NEXTERONE may cause worsening of existing arrhythmias or precipitate a new arrhythmia sometimes leading to fatal outcomes. Monitor patients for QTc prolongation during infusion with NEXTERONE.
  • Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure.
  • Amiodarone inhibits p‐glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs.
  • The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, AV block, and torsade de pointes.
  • The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock.

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