BRIVARACETAM CONSILIENT HEALTH

Posology The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and caregiver to administer Brivaracetam oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box.

2 The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table. The dose should be administered in two equally divided doses, approximately 12 hours apart. 5 mg/kg/day 1 – 5 mg/kg/day * Based on individual patient response, the dose may be adjusted within this effective dose range.

** Based on physician’s assessment of need for seizure control. Adults The recommended starting dose is either 50 mg/day or 100 mg/day based on physician’s assessment of required seizure reduction versus potential side effects. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

Adolescents and children weighing 50 kg or more The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 100 mg/day.

Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day. Adolescents and children weighing from 20 kg to less than 50 kg The recommended starting dose is mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician’s assessment of need for seizure control.

The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day. Children weighing from 10 kg to less than 20 kg The recommended starting dose is 1 mg/kg/day.

5 mg/kg/day based on physician’s assessment of need for seizure control. 5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day. 1 ml increment corresponds to 1 mg of brivaracetam).

25 ml up to 5 ml are shown. 5 mg of brivaracetam). The physician should instruct the patient on the appropriate syringe to use. 5 ml) or more and up to 50 mg (5 ml), the 5 ml oral syringe should be used. If the calculated dose per intake is more than 50 mg (5 ml), the larger 10 ml oral syringe should be used.

The calculated dose should be rounded to the nearest graduated increment. If the calculated dose is equidistant between two graduated increments, the larger graduated increment should be used. The table below provides examples of volumes of oral solution per intake depending on prescribed dose and body weight.

The precise volume of oral solution is to be calculated according to the exact body weight of the child. Note that the dosage is limited to the available graduations of the syringes. 2 ml. 1 ml. 5 mg/kg/intake) For a […]

0 %). They were usually mild to moderate in intensity. Somnolence and fatigue were reported at a higher incidence with increasing dose. 7 % for patients randomized to placebo. 8 %). Tabulated list of adverse reactions In the table below, adverse reactions, which were identified based on review of the three placebo-controlled, fixed-dose studies safety database in subjects ≥ 16 years of age, and from post marketing experience 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) ) and not known (frequency cannot be estimated from available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System organ class Frequency Adverse reactions from clinical studies Infections and infestations Common Influenza Blood and lymphatic system disorders Uncommon Neutropenia Immune system disorders Uncommon Type I hypersensitivity 12 Metabolism and nutrition disorders Common Decreased appetite Common Depression, anxiety, insomnia, irritabilityPsychiatric disorders Uncommon Suicidal ideation, psychotic disorder, aggression, agitation Very common Dizziness, somnolenceNervous system disorders Common Convulsion, vertigo Respiratory, thoracic and mediastinal disorders Common Upper respiratory tract infections, cough Gastrointestinal disorders Common Nausea, vomiting, constipation Skin and subcutaneous tissue disorders Not known Stevens-Johnson syndrome(1) General disorders and administration site conditions Common Fatigue (1) Adverse reactions reported in post marketing experience.

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. 7 % (3/459) placebo patients. 4). Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.

Paediatric population The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. 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.

7 %). 13 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. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic drugs (AEDs), including brivaracetam, in several indications. A meta- analysis of randomized placebo-controlled clinical studies of AEDs has also shown a small increased risk of suicidal ideation and behaviour.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for brivaracetam. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge. 8, paediatric data. Hepatic impairment There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment.

2). 7 Severe cutaneous adverse reactions (SCARs) Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, have been reported in association with brivaracetam treatment.

At the time of the prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, brivaracetam should be withdrawn immediately and an alternative treatment should be considered.

Excipients Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium free’. Fructose intolerance This medicinal product contains 168 mg sorbitol in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.

Excipients which may cause intolerance The oral solution contains methyl-parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520).

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