FLECAINIDE ACETATE
FLECAINIDE ACETATE is indicated for the treatment of Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia; Atrioventricular Reentrant Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Arrhythmia; Ventricular Tachycardia.
Details
- Status
- Prescription
- First Approved
- 2001-07-31
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
FLECAINIDE ACETATE Approval History
What FLECAINIDE ACETATE Treats
7 indicationsFLECAINIDE ACETATE is approved for 7 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Supraventricular Tachycardia
- Atrioventricular Nodal Reentrant Tachycardia
- Atrioventricular Reentrant Tachycardia
- Atrial Fibrillation
- Atrial Flutter
- Ventricular Arrhythmia
- Ventricular Tachycardia
FLECAINIDE ACETATE Boxed Warning
WARNINGS Mortality Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide acetate compared with that seen in ...
WARNINGS Mortality Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide acetate compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 16/315 (5.1%) for flecainide acetate and 7/309 (2.3%) for the matched placebo. The average duration of treatment with flecainide acetate in this study was ten months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including flecainide acetate), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. Ventricular Pro-arrhythmic Effects in Patients with Atrial Fibrillation/Flutter A review of the world literature revealed reports of 568 patients treated with oral flecainide acetate for paroxysmal atrial fibrillation/flutter (PAF). Ventricular tachycardia was experienced in 0.4% (2/568) of these patients. Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF. FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION. Case reports of ventricular proarrhythmic effects in patients treated with flecainide acetate for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death. As with other Class I agents, patients treated with flecainide acetate for atrial flutter
FLECAINIDE ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in FLECAINIDE ACETATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FLECAINIDE ACETATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FLECAINIDE ACETATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03539302 INSTANT results posted | FLE-002 | Ph 2 | completed | INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLECAINIDE ACETATE FDA Label Details
Indications & Usage
FLECAINIDE ACETATE is indicated for the treatment of Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia; Atrioventricular Reentrant Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Arrhythmia; Ventricular Tachycardia.
WARNINGS Mortality Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial in...
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Full clinical data, patents, trials, and competitive landscape for flecainide acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.