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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/189092/2011

EMEA/H/C/001215

EPAR summary for the public

Brinavess

vernakalant hydrochloride

This document is a summary of the European public assessment report (EPAR) for Brinavess. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Brinavess.

What is Brinavess?

Brinavess is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance vernakalant hydrochloride.

What is Brinavess used for?

Brinavess is used to rapidly restore normal heart rhythm in adult patients (aged 18 years or over) who have recently started having atrial fibrillation. Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm. Brinavess is to be used for fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery.

The medicine can only be obtained with a prescription.

How is Brinavess used?

Brinavess should be given by a qualified healthcare professional in a setting where the patient's heart can be properly monitored. The healthcare professional should monitor the patient during and for at least 15 minutes after administration of the medicine.

Patients in atrial fibrillation should receive 3 mg per kilogram body weight given as a 10-minute infusion into a vein. If the heart rhythm has not returned to normal 15 minutes after the first infusion has been given, a second dose of 2 mg/kg should be given. Patients should not be given more than

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5 mg/kg of Brinavess within any 24-hour period. For more information on the use of Brinavess, see the summary of product characteristics (also part of the EPAR).

How does Brinavess work?

The active substance in Brinavess, vernakalant, is an anti-arrhythmic medicine. It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria. By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation. Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).

How has Brinavess been studied?

In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment). A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery. The main measure of effectiveness was the proportion of patients whose heart rhythm returned to normal.

What benefit has Brinavess shown during the studies?

Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation. In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo. In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.

What is the risk associated with Brinavess?

The most common side effects with Brinavess (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and sneezing. For the full list of all side effects reported with Brinavess, see the package leaflet.

Brinavess should not be used in people who may be hypersensitive (allergic) to vernakalant hydrochloride or any of the other ingredients. It must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate. Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks). Patients on Brinavess must not be given medicines called 'class I and III anti-arrhythmics' intravenously during the four hours before or after their Brinavess infusion.

Why has Brinavess been approved?

The CHMP decided that Brinavess's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Brinavess?

The company that makes Brinavess will ensure that healthcare professionals expected to use the medicine in all Member States are provided with educational material explaining how the medicine should be used.

Brinavess

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Other information about Brinavess:

The European Commission granted a marketing authorisation valid throughout the European Union for Brinavess on 01 September 2010.

The full EPAR for Brinavess can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Brinavess, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2011.

Brinavess

EMA/189092/2011