Briviact -Brivaracetam

What is Briviact-Brivaracetam used for and what is it used for?

Briviact is an anti-epileptic medicine used in addition to other anti-epileptic medicines for the treatment of partial onset seizures (epileptic seizures that begin in a specific area of the brain). It can be taken by adults and adolescents aged 16 and over subject to partial seizures, with or without secondary generalization (ie when abnormal electrical activity extends into the brain).

Briviact contains the active substance brivaracetam.

How is Briviact -Brivaracetam used?

Briviact is available as tablets (10, 25, 50, 75 and 100 mg), in an oral solution (10 mg / mL) and in a solution for injection or infusion (drip) into a vein (10 mg / mL). The recommended starting dose is 25 mg or 50 mg twice a day, depending on the patient's condition. The dose can be adjusted according to the patient's needs, up to a maximum of 100 mg twice a day.

Briviact can be given by injection or infusion (drip) into a vein if oral administration is not possible.

For more information, see the package leaflet.

The medicine can only be obtained with a prescription.

How does Briviact -Brivaracetam work?

The active substance in Briviact, brivaracetam, is an anti-epileptic medicine. Epilepsy is caused by excess electrical activity in certain areas of the brain. The exact modes of action of brivaracetam are not yet fully known; however the medicine binds to a protein, called protein 2A of the synaptic vesicle, which intervenes in the release of chemical transmitters from nerve cells. This allows Briviact to stabilize electrical activity in the brain and prevent seizures.

What benefits of Briviact -Brivaracetam have been shown in studies?

Briviact was more efficient than placebo (a dummy treatment) in reducing seizures. This was observed in three main studies involving 1 558 patients aged 16 and over. Patients were given either Briviact or placebo, in addition to the anti-epileptic treatments already taken. Considering the three studies as a whole, the frequency of crises has halved (at least) in 34- 38% of patients who added Briviact to their therapy at doses ranging from 25 to 100 mg twice a day. The improvement achieved in patients who added placebo was 20% instead.

What are the risks associated with Briviact -Brivaracetam?

The most common side effects of Briviact (which may affect more than 1 in 10 people) are drowsiness and dizziness. For the full list of all side effects reported with Briviact, see the package leaflet.

Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (medicines with a chemical structure similar to that of brivaracetam) or to any of the other ingredients.

Why has Briviact -Brivaracetam been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Briviact's benefits are greater than its risks and recommended that it be approved for use in the EU.

Clinical studies have shown that the addition of Briviact to antiepileptic therapy was more effective than the addition of placebo in controlling partial onset seizures in adults and adolescents aged 16 and older. The side effects of Briviact have been considered for the most part to be manageable, as they are slightly or moderately severe.

What measures are being taken to ensure the safe and effective use of Briviact -Brivaracetam?

A risk management plan has been developed to ensure that Briviact is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Briviact, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information is available in the summary of the risk management plan.