Limited coverage drugs – dronedarone

Generic name	dronedarone
Strength	400 mg
Form	tablet

Special Authority criteria	Approval period
For long-term rhythm control of atrial fibrillation (AF) AND For patients with AF who successfully achieved rhythm control on amiodarone, but who develop intolerable adverse effects to amiodarone, not including liver adverse effects. Notes: Dronedarone is contraindicated in patients with NYHA Class IV heart failure OR NYHA Class II – III heart failure with a recent decompensation.	Indefinite

Practitioner exemptions

• None

Special notes

1. Rate control with appropriate anticoagulation is a cornerstone treatment strategy for patients with atrial fibrillation. Dronedarone is not a Limited Coverage benefit as monotherapy for rate control and should be used in combination with other drugs for this purpose
2. Successful rhythm control is defined as electrocardiogram evidence of normal sinus rhythm sustained over 6 months
3. Due to the potential risk of hepatotoxicity, ongoing monitoring of liver function tests is strongly recommended, and should be done in accordance with the guidelines in the product monograph
4. Clinical judgement is warranted to assess the potential risk of adverse outcomes (including death) with dronedarone in patients with heart failure, especially those with a recent decompensation. As per the U.S. drug monograph, dronedarone is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II – III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic

Special Authority request form(s)

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• 5328 - General Special Authority Request (PDF, 656KB)