Briviact (in Italy: Nubriveo)

Briviact can only be obtained with a prescription. The medicine is available as tablets, an oral solution (a liquid taken by mouth) and a solution for injection or infusion (drip) into a vein, which is used when the medicine cannot be given by mouth.

The recommended starting dose depends on the patient’s body weight. After starting treatment, the dose can be adjusted according to the patient’s needs.

For more information about using Briviact, see the package leaflet or contact a doctor or pharmacist.

Epilepsy is caused by excessive electrical activity in certain areas of the brain. The exact way in which brivaracetam, the active substance in Briviact, works is not clear, but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Briviact to stabilise electrical activity in the brain and prevent seizures.

Briviact is more effective than placebo (a dummy treatment) at reducing seizures. This was shown in three main studies involving a total of 1,558 patients aged 16 years and above. Either Briviact or placebo was added to patients’ usual epilepsy treatment. Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day. This compares with 20% in those adding placebo.

Supportive studies showed that the doses recommended for children produced similar amounts of the medicine in the body to those seen with recommended doses in adults. Therefore Briviact is expected to work in children in the same way.

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

The European Medicines Agency decided that Briviact’s benefits are greater than its risks and it can be authorised for use in the EU.

Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and children from 2 years of age. Most side effects of Briviact were of mild or moderate severity and were considered manageable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Briviact have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Briviact are continuously monitored. Side effects reported with Briviact are carefully evaluated and any necessary action taken to protect patients.

Briviact received a marketing authorisation valid throughout the EU on 14 January 2016.