BPA-FLECAINIDE

What it is

BPA-FLECAINIDE contains flecainide acetate, available as 50 mg and 100 mg tablets. Flecainide acetate belongs to the membrane stabilising (Class 1) group of antiarrhythmic agents. The predominant action of flecainide acetate is to inhibit the fast, or sodium, channel which is largely responsible for the rapid upstroke of the myocardial action potential in cardiac conducting tissue.

Approved indications

— Supraventricular arrhythmias due to pre-excitation syndromes such as Wolff-Parkinson-White and Lown-Ganong-Levine syndromes. — Supraventricular arrhythmias due to dual atrioventricular nodal pathways in patients with debilitating symptoms. — Paroxysmal atrial fibrillation or flutter associated with disabling symptoms. — Life threatening ventricular arrhythmias not controlled by other drugs, used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.

Dosing overview

The dosage of BPA-FLECAINIDE must be adjusted to the individual needs of each patient based on therapeutic response and tolerance, and dosage may need to be modified if the age, weight, or clinical status of the patient dictates. For supraventricular arrhythmias, doses may be increased in increments of 50 mg twice daily every four days until efficacy is achieved, with a maximum recommended dose of 300 mg per day. For sustained ventricular tachycardia, most patients do not require more than 150 mg every 12 hours (300 mg per day), and the maximum dose recommended is 400 mg per day. Dosage increases should be made no more frequently than once every four days, since during the first 2 to 3 days of therapy the optimal effect of a given dose may not be achieved.

Key safety warnings

In the Cardiac Arrhythmia Suppression Trial (CAST), a long-term, large scale, randomised, placebo-controlled clinical trial in patients with asymptomatic non-life threatening ventricular arrhythmias who had myocardial infarction more than six days but less than two years previously, oral flecainide was associated with a higher incidence of mortality or non-fatal cardiac arrest compared with placebo, with an average duration of treatment of 10 months. It is prudent to consider the prophylactic use of Class I antiarrhythmic drugs following myocardial infarction as potentially hazardous, and the use of these agents for other than life-threatening arrhythmias or severe symptoms due to arrhythmias is not recommended. Patients with structural heart disease treated with BPA-FLECAINIDE for supraventricular arrhythmias may be at increased risk for proarrhythmia and cardiac adverse events, with use associated with life-threatening and occasionally fatal ventricular arrhythmias; in these patients, especially in the presence of impaired left ventricular function with ejection fraction ≤ 40%, flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate. BPA-FLECAINIDE is not recommended for use in patients with chronic atrial fibrillation. A paradoxical increase in the ventricular rate may occur in patients with atrial fibrillation who receive BPA-FLECAINIDE; concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication. Because BPA-FLECAINIDE has a mild negative inotropic effect, it may cause or worsen congestive heart failure, particularly in patients with cardiomyopathy, pre-existing severe heart failure (NYHA functional class III or IV) or ejection fractions ≤ 40%, and should therefore be used cautiously in patients who are known to have a history of congestive heart failure or myocardial dysfunction. BPA-FLECAINIDE should not be used in patients with advanced sinus node disease and should be used only with extreme caution in patients with sick sinus syndrome because it may cause sinus bradycardia, sinus pause, or sinus arrest, and pacing rescue facilities should be available.

Contraindications

— Second or third degree atrioventricular block, unless a pacemaker is present to sustain rhythm. — Right bundle branch block when associated with a left hemi-block (bifascicular block) unless a pacemaker is present to sustain rhythm. — Cardiogenic shock. — Asymptomatic premature ventricular contractions and/or asymptomatic non-sustained ventricular tachycardia in patients with a history of myocardial infarction. — Known hypersensitivity to the drug. — Severe renal or hepatic impairment unless plasma level monitoring can be done.

Regulatory history

BPA-FLECAINIDE 50 mg and 100 mg tablet blister packs were first listed on the Australian Register of Therapeutic Goods on 15 April 2020.