Briviact Adverse Reactions

Summary of the safety profile: The most frequently reported adverse reactions (>10%) with brivaracetam treatment were: somnolence (14.3%) and dizziness (11.0%). They were usually mild to moderate in intensity. Somnolence and fatigue (8.2%) were reported at a higher incidence with increasing dose.
The discontinuation rate due to adverse reactions was 3.5%, 3.4% and 4.0% for patients randomized to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7% for patients randomized to placebo. The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8%) and convulsion (0.8%).
Tabulated list of adverse reactions: In Table 7, adverse reactions, which were identified based on review of the three placebo-controlled, fixed-dose studies safety database in subjects ≥16 years of age, are listed by System Organ Class and frequency.
The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 7.)

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Description of selected adverse reactions: Neutropenia has been reported in 0.5% (6/1,099) brivaracetam patients and 0% (0/459) placebo patients. Four of these subjects had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of brivaracetam treatment. None of the 6 cases of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.
Suicidal ideation has been reported in 0.3% (3/1,099) brivaracetam patients and 0.7% (3/459) placebo patients. In the short-term clinical studies of brivaracetam in epilepsy patients, there were no cases of completed suicide and suicide attempt, however both have been reported in open-label extension studies (see Precautions).
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3,022) during clinical development.
Adverse reactions with intravenous administration generally appeared to be similar to those observed with oral administration. Intravenous administration was associated with infusion site pain in 2.8% of the patients.
Paediatric population: Film-coated tablet / Oral solution: The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7% of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4% of adults and behavioural disorders were reported in 24.8% of paediatric patients compared with 15.1% of adults. The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7%).
No specific pattern of adverse event (AE) was identified in children from 1 month to <4 years of age when compared to older paediatric age groups. No significant safety information was identified indicating the increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age is limited, brivaracetam is not indicated in this age range. Limited clinical data are available in neonates.
Solution for injection/infusion: There are limited safety data from open-label studies in children from 1 month to <16 years of age. A total of 152 children (1 month to <16 years of age) were treated with brivaracetam in a pharmacokinetic study and the related follow up study. From the limited available data, the most frequently reported TEAEs considered drug-related by the investigator were somnolence (10%), decreased appetite (8%), fatigue (5%) and weight decreased (5%). The safety profile appears to be consistent with that known in adults. No data are available on neurodevelopment. Currently, no clinical data are available in neonates.
Elderly: Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age. The safety profile in elderly patients appears to be similar to that observed in younger adult patients.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.