Brand Name :
Briviact
Synonyms :
brivaracetam
Class :
SV2A Ligands
Dosage Forms & Strengths
Tablet
10mg
25mg
50mg
75mg
100mg
Oral solution
10mg/mL
Injection solution
50mg/5mL single-dose vial
50 mg orally/IV 2 times a day; dose can be adjusted b/w 25-100 mg orally/IV
When oral delivery is temporarily unfeasible, patients may use injections;
however, clinical study experience with injection is only available for 4 consecutive days of treatment
Note:
Used to treat partial-onset seizures
Dosage Forms & Strengths
Tablet
10mg
25mg
50mg
75mg
100mg
Oral solution
10mg/mL
Injection solution
50mg/5mL single-dose vial
Age: 1 month-16 years
Wt <11 kg: 0.75-1.5 mg/kg orally every 12 hours; may be increased to 0.75-3 mg/kg
Wt 11-<20 kg: 0.5-1.25 mg/kg orally every 12 hours; may be increased to 0.5 to 2.5 mg/kg
Wt 20-<50 kg: 0.5 to 1 mg/kg orally every 12 hours; may be increased to 0.5 to 2 mg/kg
Wt ≥50 kg: 25-50 mg orally every 12 hours; may be increased to 25 to 100 mg
Age: ≥16 years
50 mg orally every 12 hours; may be increased to 25 mg-100 mg
Note:
Used to treat partial-onset seizures
Refer to adult dosing
CYP2C19 Inducers: they may diminish the serum concentration of brivaracetam
CYP2C19 Inducers: they may diminish the serum concentration of brivaracetam
CYP2C19 Inducers: they may diminish the serum concentration of brivaracetam
CYP2C19 Inducers: they may diminish the serum concentration of brivaracetam
CYP2C19 Inducers: they may diminish the serum concentration of brivaracetam
It may enhance sedation when combined with oxycodone
CYP2C19 enhancers (moderate) may reduce the therapeutic efficacy of brivaracetam
may increase the adverse effect of Immunosuppressants
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may enhance the adverse/toxic effect of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may increase the risk of adverse effects of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
may enhance the adverse effect of antipsychotic agents
brivaracetam and codeine lead to increased sedative effects
may enhance the concentration of serum when combined with brivaracetam
may enhance the concentration of serum when combined with brivaracetam
it may diminish the metabolism when combined with diosmin
Combining brivaracetam with pranlukast may cause a reduction in the brivaracetam’s metabolism
The potential for increased CNS depression risk or seriousness occurs when brivaracetam is used together with pipecuronium
brivaracetam has the potential to reduce the rate of excretion of idebenone, leading to an elevation in levels of serum
When captodiame is used together with brivaracetam, There is a risk or seriousness of CNS depression is enhanced
When brivaracetam is used together with medazepam, the risk or seriousness of CNS depression is enhanced
The potential for CNS depression may enhanced when brivaracetam is used together with fencamfamin
Decreased therapeutic activity of brivaracetam.
it decreases the efficacy of antiseizure agents
may increase the toxic effect of anti-Parkinson agents
Actions and Spectrum:
The action of brivaracetam is not fully understood, but it is believed to work by binding to a specific type of receptor in the brain called the synaptic vesicle protein 2A (SV2A) receptor. This binding is thought to enhance the release of neurotransmitters, such as GABA, which can help to reduce seizures.
The spectrum of activity of brivaracetam includes the treatment of seizures and other neurological conditions, such as anxiety and depression. It may also have potential for use in cognitive enhancement and memory improvement. However, further research is needed to fully understand the potential benefits and risks of brivaracetam in these areas.
Frequency Defined
>10%
Dizziness (12%)
Somnolence and sedation (16%)
1-10%
Nausea and vomiting (5%)
Constipation (2%)
Fatigue (9%)
Irritability (3%)
Black Box Warning
The FDA has issued a black box warning for brivaracetam due to the risk of suicidal thoughts and behaviors. This warning states that patients taking brivaracetam should be monitored closely for signs of suicidal thoughts or behavior, and that healthcare providers should inform patients and caregivers about the risk of suicide.
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy warnings:
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Lactation:
Excreted into human milk is known
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
brivaracetam (brand name: Briviact) is a medication used to treat seizures in people with epilepsy. It is classified as a selective, high-affinity, and positive allosteric modulator of the synaptic vesicle protein 2A (SV2A) receptor.
Pharmacodynamics:
Mechanism of Action: The exact mechanism of action of brivaracetam is not fully understood, but it is believed to work by binding to the SV2A receptor in the brain. This binding increases the release of the neurotransmitter GABA, which helps to inhibit the abnormal electrical activity in the brain that causes seizures.
Pharmacokinetics:
Absorption
brivaracetam has a high oral bioavailability and is rapidly and almost completely absorbed after oral administration. It has a peak plasma time of 1 hour, but this can be delayed with a high-fat meal.
Distribution
The protein binding of brivaracetam is low, at ≤20%, and it has a relatively low volume of distribution (Vd) of 0.5 L/kg.
Metabolism
The metabolism of brivaracetam is primarily mediated by hepatic and extra-hepatic amidase, which converts the drug into its carboxylic acid metabolite. This metabolite is not pharmacologically active and is excreted through the urine.
brivaracetam is also metabolized by CYP2C19, which leads to the formation of the hydroxy metabolite.
Elimination and excretion
The half-life of brivaracetam is around 9 hours, which means that half of the drug is eliminated from the body within 9 hours after a single dose.
brivaracetam is primarily excreted through the urine, with more than 95% of the dose being eliminated in this way. Less than 1% of the dose is excreted through the feces.
In terms of excretion of the drug and its metabolites, less than 10% of the dose is excreted unchanged in the urine, while 34% of the dose is excreted as the carboxylic acid metabolite in urine. The remaining fraction of the dose is eliminated as other inactive metabolites.
Administration:
Oral administration
brivaracetam is administered orally, typically as a tablet or oral solution. The recommended dosage and frequency of administration will vary depending on the individual’s condition and response to treatment. It is important to follow the dosing instructions provided by a healthcare provider and not to alter or stop taking the medication without consulting a healthcare provider.
brivaracetam should be taken with or without food. If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule should be resumed.
It is important to note that brivaracetam may cause drowsiness or dizziness and should be used with caution when operating heavy machinery or driving. It may also interact with other medications, and it is important to inform a healthcare provider of all medications being taken.
Patient information leaflet
Generic Name: brivaracetam
Why do we use brivaracetam?
brivaracetam is used to treat seizures, particularly in adults with epilepsy who have not adequately responded to other treatments. It is a type of antiepileptic drug that works by binding to a specific type of protein in the brain called the SV2A protein. This binding helps to reduce the activity of nerve cells in the brain that are involved in seizures.
brivaracetam is typically used as an adjunctive therapy, meaning it is used in combination with other antiepileptic drugs. It is used to control seizures that are not well-controlled with other treatments, and it may be used in people who have had seizures that are difficult to control or have a high risk of seizures.