BRINAVESS (Vernakalant)
Antiarrhythmic agent for rapid conversion of recent-onset atrial fibrillation
BRINAVESS (vernakalant hydrochloride) is a prescription antiarrhythmic medication administered as an intravenous infusion in hospital settings. It is used for the rapid conversion of recent-onset atrial fibrillation (AF) to normal sinus rhythm in adults. BRINAVESS works by selectively targeting ion channels in the atria of the heart, restoring normal heart rhythm typically within minutes. It is approved for AF episodes lasting 7 days or less in non-surgical patients, or 3 days or less after cardiac surgery.
Quick Facts
Key Takeaways
- BRINAVESS is a hospital-only IV antiarrhythmic that rapidly converts recent-onset atrial fibrillation to normal sinus rhythm, often within 8–14 minutes.
- The initial dose is 3 mg/kg infused over 10 minutes; a second dose of 2 mg/kg may follow after 15 minutes if needed. Maximum 5 mg/kg per 24 hours.
- Must be administered under continuous ECG monitoring with cardioversion equipment readily available.
- Contraindicated in severe heart failure (NYHA III–IV), severe aortic stenosis, systolic blood pressure below 100 mmHg, and recent acute coronary syndromes.
- Most common side effects are taste disturbance and sneezing; hypotension and bradycardia may occur and require immediate medical attention.
What Is BRINAVESS and What Is It Used For?
Quick Answer: BRINAVESS (vernakalant hydrochloride) is an intravenous antiarrhythmic medication used in hospital settings to rapidly convert recent-onset atrial fibrillation (an irregular, often rapid heart rhythm originating in the upper chambers of the heart) back to a normal sinus rhythm. It is approved for adults whose atrial fibrillation episode has lasted 7 days or less, or 3 days or less following cardiac surgery.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide, affecting an estimated 33 million people globally according to the World Health Organization. During AF, the electrical signals in the upper chambers (atria) of the heart become chaotic, causing the heart to beat irregularly and often too quickly. This can lead to symptoms such as palpitations, shortness of breath, fatigue, and dizziness, and significantly increases the risk of stroke and heart failure if left untreated.
BRINAVESS contains the active substance vernakalant hydrochloride, which belongs to a class of medications known as antiarrhythmic agents. Unlike many older antiarrhythmic drugs that affect the entire heart, vernakalant has a relatively atrial-selective mechanism of action. This means it preferentially acts on the ion channels found in the atrial tissue rather than in the ventricles, which are the heart's main pumping chambers. This selectivity is a key pharmacological advantage because it reduces the risk of dangerous ventricular arrhythmias that can occur with other antiarrhythmic medications.
Vernakalant works by blocking specific ion channels in the atria, primarily the ultra-rapid delayed rectifier potassium current (IKur) and frequency-dependent sodium channels. By blocking these channels, vernakalant slows electrical conduction through the atria and prolongs the atrial refractory period (the time during which the atrial tissue cannot be re-excited), thereby interrupting the chaotic electrical circuits that sustain atrial fibrillation and restoring organized, regular sinus rhythm.
The European Medicines Agency (EMA) approved BRINAVESS in 2010 based on a robust clinical trial programme. The pivotal trials—ACT I (Atrial arrhythmia Conversion Trial I), ACT II (post-cardiac surgery), ACT III, and ACT IV (SCENE 2)—demonstrated that vernakalant was significantly more effective than placebo at converting recent-onset AF to sinus rhythm, with conversion rates of approximately 51% within 90 minutes compared to 4% with placebo. The median time to conversion was rapid, typically 8 to 14 minutes from the start of the first infusion.
What Should You Know Before Receiving BRINAVESS?
Quick Answer: Before receiving BRINAVESS, your doctor must evaluate you for several contraindications including severe heart failure, recent heart attack, very low blood pressure, severe valve disease, and certain heart rhythm abnormalities. Inform your doctor about all medications you are taking, especially other antiarrhythmic drugs, as well as any history of heart disease, liver problems, or pregnancy.
BRINAVESS is a potent cardiac medication that requires careful patient selection. Your treating physician will perform a thorough evaluation before deciding whether this treatment is appropriate for you. This evaluation typically includes a physical examination, ECG recording, blood pressure measurement, review of your medical history, and assessment of the duration and nature of your atrial fibrillation episode.
Contraindications
You must not receive BRINAVESS if any of the following conditions apply:
- Allergy to vernakalant or any of the other ingredients in the product (citric acid, sodium chloride, sodium hydroxide, water for injections).
- Acute coronary syndrome (including myocardial infarction or unstable angina) within the past 30 days. Vernakalant has not been studied in this high-risk population and could potentially worsen cardiac ischaemia.
- Severe aortic stenosis (a markedly narrowed aortic heart valve), which limits the heart's ability to compensate for haemodynamic changes caused by the drug.
- Systolic blood pressure below 100 mmHg, indicating pre-existing hypotension that could be dangerously worsened by vernakalant.
- Advanced heart failure classified as NYHA functional class III (symptoms with minimal exertion) or class IV (symptoms at rest). Patients with severe heart failure are at significantly higher risk of hypotension and ventricular arrhythmias.
- QT interval prolongation with an uncorrected QT interval exceeding 440 milliseconds on the ECG, which increases the risk of dangerous torsade de pointes arrhythmia.
- Severe bradycardia (abnormally slow heart rate), sinus node dysfunction, or second- or third-degree atrioventricular (AV) block in patients without a pacemaker.
- Recent intravenous antiarrhythmic therapy: use of IV class I antiarrhythmics (e.g., flecainide, propafenone) or class III antiarrhythmics (e.g., amiodarone, ibutilide) within the 4 hours before BRINAVESS is to be administered, or during the 4 hours following its administration.
Warnings and Precautions
Speak with your doctor before receiving BRINAVESS if you have any of the following conditions, as special caution and closer monitoring may be required:
- Chronic heart failure (NYHA I–II): Patients with a history of chronic heart failure have shown a higher incidence of hypotensive events (13.4% with vernakalant vs 4.7% with placebo) and ventricular arrhythmias (6.4% vs 1.6%) in clinical trials. Vernakalant should be used with caution in haemodynamically stable patients with NYHA class I–II heart failure. Use is not recommended in patients with left ventricular ejection fraction (LVEF) of 35% or less.
- Valvular heart disease: Higher rates of ventricular arrhythmias have been observed in patients with valvular disease (6.4% with vernakalant vs 0% with placebo within the first 2 hours). These patients require especially close monitoring.
- Liver disease: Vernakalant is metabolized partly through hepatic pathways. There is limited clinical experience in patients with severe liver impairment, and use is not recommended in this group.
- Pacemaker: Limited clinical data are available regarding the use of vernakalant in patients with implanted pacemakers. Inform your doctor if you have a pacemaker.
- Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis: Vernakalant has not been evaluated in these conditions, and use cannot be recommended.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, speak with your doctor before receiving this medication. BRINAVESS should preferably be avoided during pregnancy as its effects on the developing foetus have not been adequately studied in humans. There are no adequate data regarding the use of vernakalant in pregnant women, and animal studies have shown reproductive toxicity at doses significantly higher than the therapeutic dose.
It is not known whether vernakalant or its metabolites pass into human breast milk. A decision must be made by the treating physician, weighing the benefit of the treatment against the potential risk to the nursing infant. Given the short duration of exposure (single IV dose with a short half-life), the risk is generally considered low, but caution is advised.
Pre-Treatment Assessment
Before administering BRINAVESS, your doctor will ensure that you are adequately hydrated and haemodynamically optimised. Blood tests may be performed to check your potassium levels, as hypokalaemia (low potassium, defined as serum potassium below 3.5 mmol/L) must be corrected before administration of vernakalant. Coagulation parameters may also be assessed, and anticoagulation therapy should be initiated as per current treatment guidelines, given the thromboembolic risks associated with atrial fibrillation and its conversion.
Children and Adolescents
BRINAVESS should not be given to children and adolescents under 18 years of age. There is no clinical experience with vernakalant in the paediatric population, and there is no relevant indication for this age group in the treatment of recent-onset atrial fibrillation.
Driving and Operating Machinery
Some patients may experience dizziness, usually within the first 2 hours after receiving BRINAVESS. You should not drive or operate machinery if you feel dizzy following the infusion. As this medication is administered in a hospital setting, you will typically be monitored for an appropriate period before being discharged.
Sodium Content
BRINAVESS contains sodium. The 200 mg vial contains 32 mg sodium (equivalent to 1.6% of the WHO-recommended maximum daily intake of 2 g sodium for adults). The 500 mg vial contains 80 mg sodium (equivalent to 4% of the recommended maximum). This should be considered for patients on a controlled sodium diet.
How Does BRINAVESS Interact with Other Drugs?
Quick Answer: The most critical interaction is with other intravenous antiarrhythmic drugs (class I and III), which must not be given within 4 hours before or after BRINAVESS. Vernakalant is metabolised by CYP2D6 and is itself a moderate CYP2D6 inhibitor, but due to its short half-life no significant drug interactions are expected with most other medications.
No formal drug interaction studies have been conducted with BRINAVESS. However, based on its pharmacological profile and the available clinical data, the following interactions are recognised and must be considered by the treating physician:
Major Interactions
The most clinically significant interaction is with other antiarrhythmic agents. Vernakalant must not be given to patients who have received intravenous class I antiarrhythmics (such as flecainide or propafenone) or class III antiarrhythmics (such as amiodarone, ibutilide, or sotalol given intravenously) within the preceding 4 hours. Similarly, these IV antiarrhythmics must not be given during the 4 hours following vernakalant administration. This restriction exists because the combined effects on cardiac ion channels could result in excessive prolongation of cardiac conduction intervals and increase the risk of proarrhythmic events.
In the clinical trial programme, oral antiarrhythmic maintenance therapy was withheld for at least 2 hours after vernakalant administration. Resumption of or initiation of oral antiarrhythmic maintenance therapy may be considered 2 hours after treatment with vernakalant. However, vernakalant should be used with caution in patients already receiving oral class I or class III antiarrhythmics, as there is limited experience and a potentially increased risk of atrial flutter.
| Drug / Class | Type | Clinical Significance | Recommendation |
|---|---|---|---|
| IV Class I antiarrhythmics (flecainide, propafenone) | Contraindicated | Additive cardiac ion channel blockade; risk of proarrhythmia | Do not use within 4 hours before or after BRINAVESS |
| IV Class III antiarrhythmics (amiodarone, ibutilide, sotalol IV) | Contraindicated | Additive QT prolongation; risk of torsade de pointes | Do not use within 4 hours before or after BRINAVESS |
| Oral Class I/III antiarrhythmics | Caution | Limited data; possible increased risk of atrial flutter | Use with caution; resume oral therapy no sooner than 2 hours after |
| CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) | Low risk | Vernakalant is a CYP2D6 substrate; no clinically significant change in acute exposure observed | No dose adjustment required |
| CYP2D6 substrates (e.g., metoprolol, dextromethorphan) | Low risk | Vernakalant is a moderate CYP2D6 inhibitor but short half-life limits impact | No dose adjustment expected for chronic 2D6 substrates |
Pharmacokinetic Considerations
Vernakalant is primarily metabolised by the CYP2D6 enzyme system. However, population pharmacokinetic analyses from the clinical trial programme have shown no clinically meaningful difference in acute vernakalant exposure (Cmax and AUC0–90 min) when weak or potent CYP2D6 inhibitors were co-administered within 1 day before infusion, compared with patients not receiving CYP2D6 inhibitors. Furthermore, patients who are CYP2D6 poor metabolisers show only minimal differences in acute exposure compared with extensive metabolisers. Therefore, no dose adjustment is required based on CYP2D6 metaboliser status or concurrent use of CYP2D6 inhibitors.
Although vernakalant is a moderate competitive inhibitor of CYP2D6, its short elimination half-life means that any enzyme inhibition is transient. Therefore, acute intravenous administration of vernakalant is not expected to significantly alter the pharmacokinetics of chronically administered CYP2D6 substrates. Vernakalant does not inhibit other tested CYP450 enzymes (CYP3A4, CYP1A2, CYP2C9, CYP2C19, or CYP2E1) and does not inhibit P-glycoprotein as demonstrated in a digoxin transport assay. Due to its rapid distribution and low protein binding, clinically relevant pharmacokinetic drug interactions are unlikely.
What Is the Correct Dosage of BRINAVESS?
Quick Answer: The initial dose of BRINAVESS is 3 mg/kg body weight, given as an IV infusion over 10 minutes. If sinus rhythm is not restored within 15 minutes, a second dose of 2 mg/kg may be given over 10 minutes. The total cumulative dose must not exceed 5 mg/kg within 24 hours. For patients weighing more than 113 kg, a fixed maximum dose applies.
BRINAVESS is always administered by qualified healthcare professionals in a hospital environment with continuous ECG monitoring and cardioversion equipment readily available. The dose is calculated based on the patient's body weight, with the maximum calculated dose based on a body weight of 113 kg.
Adults
Initial Infusion (First Dose)
Dose: 3 mg/kg body weight, administered as an intravenous infusion over 10 minutes.
Maximum initial dose: 339 mg (84.7 ml of the 4 mg/ml diluted solution), calculated for patients weighing up to 113 kg.
Fixed dose for patients >113 kg: 339 mg.
Observation Period
If conversion to sinus rhythm has not occurred by the end of the initial infusion, the patient's vital signs and heart rhythm should be observed for an additional 15 minutes before considering a second dose.
Second Infusion (If Needed)
Dose: 2 mg/kg body weight, administered as an intravenous infusion over 10 minutes.
Maximum second dose: 226 mg (56.5 ml of the 4 mg/ml diluted solution).
Fixed dose for patients >113 kg: 226 mg.
Maximum Cumulative Dose
The total dose must not exceed 5 mg/kg within 24 hours. Cumulative doses above 565 mg have not been evaluated in clinical trials.
If conversion to sinus rhythm occurs during either infusion, the ongoing infusion should be continued until complete. If haemodynamically stable atrial flutter is observed after the first dose, the second dose may still be administered as the patient may subsequently convert to sinus rhythm.
| Patient Group | Initial Dose | Second Dose | Special Considerations |
|---|---|---|---|
| Adults (≤113 kg) | 3 mg/kg IV over 10 min | 2 mg/kg IV over 10 min (after 15 min wait) | Weight-based dosing; max cumulative 5 mg/kg/24h |
| Adults (>113 kg) | 339 mg IV over 10 min (fixed) | 226 mg IV over 10 min (fixed) | Fixed dose; cumulative max 565 mg not evaluated above this |
| Post-cardiac surgery | 3 mg/kg IV over 10 min | 2 mg/kg IV over 10 min | No dose adjustment; AF duration must be ≤3 days |
| Renal impairment | 3 mg/kg IV over 10 min | 2 mg/kg IV over 10 min | No dose adjustment necessary |
| Hepatic impairment | 3 mg/kg IV over 10 min | 2 mg/kg IV over 10 min | No dose adjustment; not recommended in severe hepatic impairment |
| Elderly (≥65 years) | 3 mg/kg IV over 10 min | 2 mg/kg IV over 10 min | No dose adjustment necessary |
| Children (<18 years) | Not applicable | Not applicable | Not indicated; no paediatric data available |
Preparation and Administration
BRINAVESS is supplied as a sterile concentrate (20 mg/ml) that must be diluted before administration. The concentrate is diluted to a working concentration of 4 mg/ml using one of the following compatible diluents: sodium chloride 0.9% injection, Ringer's lactate solution, or 5% glucose (dextrose) solution. For patients weighing 100 kg or less, 25 ml of BRINAVESS concentrate is added to 100 ml of diluent. For patients weighing more than 100 kg, 30 ml is added to 120 ml of diluent.
The diluted solution should be clear and colourless to pale yellow. Solutions that are cloudy or discoloured must not be used. The diluted solution is chemically and physically stable for up to 12 hours at temperatures of 25°C or below. From a microbiological standpoint, the product should be used immediately after dilution. An infusion pump is preferred for accurate delivery of the calculated volume within the specified infusion time. A syringe pump may also be used provided it can accurately deliver the required volume.
Overdose
In the event of an overdose, clinical experience is limited. Potential consequences of overdose are likely to include exaggerated pharmacological effects such as severe hypotension, marked bradycardia, significant conduction disturbances, and potentially life-threatening ventricular arrhythmias. Treatment of overdose should be supportive and symptom-directed, including continuous cardiac monitoring, intravenous fluids for hypotension, and vasopressors if required. In severe cases, temporary cardiac pacing or electrical cardioversion may be necessary. If you suspect you have received too much BRINAVESS, inform your doctor immediately.
What Are the Side Effects of BRINAVESS?
Quick Answer: The most common side effects of BRINAVESS are taste disturbance (dysgeusia) and sneezing, occurring in more than 1 in 10 patients. Common side effects include nausea, numbness or tingling, low blood pressure, slow heart rate, dizziness, and infusion site reactions. Most side effects are transient and resolve within 24 hours. Serious but less common effects include significant heart rhythm disturbances and marked hypotension.
Like all medicines, BRINAVESS can cause side effects, although not everybody gets them. Your doctor will monitor you closely during and after the infusion and may stop the administration if certain abnormal changes are observed in your heart rhythm, blood pressure, or ECG.
The following serious events may lead your physician to discontinue the infusion immediately: very rapid or very slow heart rate, missed heart beats, a brief pause in normal heart activity, very low blood pressure that could cause serious cardiac problems, or significant changes in the heart's electrical activity as seen on the ECG. These events, while mostly uncommon, require immediate medical attention.
Very Common
May affect more than 1 in 10 patients
- Taste disturbance (dysgeusia) — an unusual or unpleasant taste in the mouth
- Sneezing
Common
May affect up to 1 in 10 patients
- Nausea and vomiting
- Numbness, tingling, or reduced sensation (paraesthesia) at the infusion site or generally
- Low blood pressure (hypotension)
- Slow heart rate (bradycardia)
- Dizziness
- Rapid heart rate (tachycardia)
- Feeling of warmth
- Cough
- Nasal discomfort or soreness
- Excessive sweating (hyperhidrosis)
- Itching (pruritus)
- Numbness or tingling in the mouth
Uncommon
May affect up to 1 in 100 patients
- Heart rhythm disturbances: palpitations, extra heart beats (premature ventricular or atrial complexes)
- Reduced sensation in the skin (hypoaesthesia)
- Eye irritation, watery eyes, or visual disturbances
- Changes in sense of smell
- Pain in fingers and toes, burning sensation
- Cold sweats, hot flushes
- Increased urge to defecate, diarrhoea
- Breathlessness (dyspnoea) or chest tightness
- Sensation of choking
- Pain in the mouth or throat
- Irritation or itching at the infusion site
- High blood pressure (hypertension)
- Feeling faint or actual fainting (syncope), general feeling of being unwell (malaise), drowsiness
- Runny nose (rhinorrhoea), sore throat, nasal congestion
- Dry mouth, pale skin colour
- Generalised pruritus, fatigue
- Decreased sensation or sensitivity in the mouth
The side effects described above, which occur within 24 hours after administration of BRINAVESS, are generally rapidly reversible. If they do not resolve promptly, you should inform your treating physician. The transient nature of most adverse effects reflects the short half-life of vernakalant and its rapid clearance from the body.
How Should BRINAVESS Be Stored?
Quick Answer: BRINAVESS concentrate requires no special storage conditions for the unopened vial. Once diluted, the solution is stable for up to 12 hours at 25°C or below. From a microbiological standpoint, it should be used immediately. The product should be kept out of the sight and reach of children.
As BRINAVESS is a hospital-use medication, storage is managed by pharmacy and healthcare staff. However, the following storage information is provided for completeness:
- Unopened vials: No special storage conditions are required. Store below the expiry date printed on the carton and vial label (EXP). The expiry date refers to the last day of that month.
- Diluted solution (chemical/physical stability): Stable for up to 12 hours when stored at 25°C or below.
- Diluted solution (microbiological): Should be used immediately after preparation. If not used immediately, in-use storage times should normally not exceed 24 hours at 2°C to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
- Visual inspection: Do not use if the solution is cloudy or discoloured. The concentrate may range from colourless to pale yellow; colour variations within this range do not affect potency.
- Keep out of the sight and reach of children.
- Dispose of unused product in accordance with local requirements. Do not dispose of via wastewater or household waste.
What Does BRINAVESS Contain?
Quick Answer: Each millilitre of BRINAVESS concentrate contains 20 mg vernakalant hydrochloride (equivalent to 18.1 mg vernakalant). It is available in 200 mg and 500 mg vials. Inactive ingredients include citric acid, sodium chloride, sodium hydroxide, and water for injections.
BRINAVESS is supplied as a clear, colourless to pale yellow sterile concentrate for solution for infusion. Understanding the composition of any medication is important for identifying potential allergens and for proper preparation.
Active Ingredient
- Vernakalant hydrochloride — 20 mg per ml of concentrate
- Each 200 mg vial contains 200 mg vernakalant hydrochloride, corresponding to 181 mg of vernakalant (free base).
- Each 500 mg vial contains 500 mg vernakalant hydrochloride, corresponding to 452.5 mg of vernakalant (free base).
Inactive Ingredients (Excipients)
- Citric acid (pH adjustment)
- Sodium chloride (tonicity agent)
- Sodium hydroxide E524 (pH adjustment)
- Water for injections (solvent)
Available Pack Sizes
BRINAVESS is available in packs containing 1 vial of either 200 mg or 500 mg vernakalant hydrochloride. The vials are for single use only and must be diluted before administration.
Marketing Authorisation Holder
Advanz Pharma Limited, Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland.
Frequently Asked Questions About BRINAVESS
BRINAVESS (vernakalant) is used for the rapid conversion of recent-onset atrial fibrillation (AF) to normal sinus rhythm in adults. It is approved for use when AF has been present for 7 days or less in non-surgical patients, or 3 days or less in patients who have recently undergone cardiac surgery. It is administered as an intravenous infusion in a hospital setting under continuous ECG monitoring.
BRINAVESS is designed for rapid cardioversion. In clinical trials, the median time to conversion was approximately 8 to 14 minutes from the start of the first infusion. Overall conversion rates of 51–52% were observed within 90 minutes in the pivotal ACT trials, compared to approximately 4% with placebo. If the first dose does not achieve conversion, a second dose can be administered after a 15-minute waiting period.
No. BRINAVESS can only be administered in a hospital or clinical setting by trained healthcare professionals. It requires continuous ECG monitoring throughout the infusion and for at least 15 minutes after completion, with cardioversion equipment readily available. Self-administration at home is not safe or possible, as the medication must be diluted from a sterile concentrate, given intravenously at a precise rate, and the patient must be monitored for potentially serious cardiac side effects.
BRINAVESS has not been shown to be effective for converting typical primary atrial flutter to sinus rhythm. In fact, some patients receiving vernakalant may convert from atrial fibrillation to atrial flutter during treatment. If haemodynamically stable atrial flutter occurs as a secondary effect of treatment, the physician may decide to continue the infusion or give the second dose, as the patient may still ultimately convert to sinus rhythm. Rare cases of 1:1 atrioventricular conduction during atrial flutter have been reported post-marketing.
If BRINAVESS does not convert your atrial fibrillation after both doses, your doctor will consider alternative approaches. Electrical cardioversion (a controlled electrical shock to reset the heart rhythm) may be considered, although there is limited clinical experience with cardioversion within 2 hours after vernakalant administration. Your doctor may also consider other pharmacological options or a rate-control strategy depending on your individual clinical circumstances, symptoms, and overall health status.
Patients must be monitored with continuous ECG throughout the infusion and for at least 15 minutes after it ends. Vital signs (blood pressure, heart rate, oxygen saturation) are checked regularly. The monitoring period extends for at least 2 hours from the start of the infusion, or until clinical parameters and the ECG have stabilised. Cardioversion equipment must be available at all times. If any serious adverse event occurs during the first infusion, a second dose must not be given.
References
- European Medicines Agency (EMA). BRINAVESS Summary of Product Characteristics. Last updated 2024. Available at: ema.europa.eu/en/medicines/human/EPAR/brinavess
- Roy D, Pratt CM, Torp-Pedersen C, et al. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial (ACT I). Circulation. 2008;117(12):1518-1525. doi:10.1161/CIRCULATIONAHA.107.723866
- Kowey PR, Dorian P, Mitchell LB, et al. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial (ACT II). Circ Arrhythm Electrophysiol. 2009;2(6):652-659. doi:10.1161/CIRCEP.109.870204
- Pratt CM, Roy D, Torp-Pedersen C, et al. Usefulness of vernakalant hydrochloride injection for rapid conversion of atrial fibrillation (ACT III). Am J Cardiol. 2010;106(9):1277-1283. doi:10.1016/j.amjcard.2010.06.054
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. Eur Heart J. 2021;42(5):373-498. doi:10.1093/eurheartj/ehaa612
- Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176
- Simon A, Niederdoeckl J, Gozdzik M, et al. Vernakalant is superior to ibutilide for achieving sinus rhythm in patients with recent-onset atrial fibrillation: a randomised controlled trial at the emergency department. Europace. 2017;19(2):233-240. doi:10.1093/europace/euw052
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- British National Formulary (BNF). Vernakalant. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
Medical Editorial Team
This article has been written and medically reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in cardiology, electrophysiology, and clinical pharmacology. All medical content follows the GRADE evidence framework and adheres to international guidelines from the European Society of Cardiology (ESC), the European Medicines Agency (EMA), and the World Health Organization (WHO).
- Evidence Level 1A (systematic reviews, RCTs)
- ESC Guidelines 2024 compliant
- EMA-approved product information
- GRADE evidence framework
- No commercial funding
- Written by medical specialists
- Peer-reviewed by cardiologists
- Fact-checked against primary sources
- Updated with new evidence
- Published: August 25, 2025
- Last reviewed: May 10, 2026