Briviact Adverse Reactions

Summary of the safety profile: In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received brivaracetam, of whom 1,740 have been treated for ≥6 months, 1,363 for ≥12 months, 923 for ≥24 months and 569 for ≥60 months (5 years).
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 types of adverse reactions reported during the first 7 days of treatment were similar to those reported for the overall treatment period.
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 the following table, 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 2.)

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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: 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.