Brivaracetam STADA
Antiepileptic medicine for partial-onset seizures (SV2A ligand)
Quick facts about Brivaracetam STADA
Key takeaways about Brivaracetam STADA
- Adjunctive therapy for focal seizures: Brivaracetam STADA is used alongside other antiepileptic medicines, not as a standalone treatment, to control partial-onset seizures in patients aged 2 years and older
- High selectivity for SV2A: Brivaracetam has approximately 15-30 times higher affinity for the SV2A protein compared to levetiracetam, which may contribute to its efficacy at lower doses
- Do not stop suddenly: Abrupt discontinuation can increase seizure frequency and potentially trigger status epilepticus; always taper the dose gradually under medical supervision
- Causes drowsiness and dizziness: These are the most common side effects; avoid driving or operating machinery until you know how the medicine affects you
- Monitor mood and behaviour: Like all antiepileptic drugs, brivaracetam may increase the risk of suicidal thoughts; report any mood changes to your doctor immediately
What Is Brivaracetam STADA and What Is It Used For?
Brivaracetam STADA is a prescription antiepileptic medicine used as adjunctive therapy for partial-onset seizures (focal seizures), with or without secondary generalisation, in patients aged 2 years and older with epilepsy. It contains the active substance brivaracetam, which works by binding to synaptic vesicle protein 2A (SV2A) in the brain.
Epilepsy is a neurological condition characterised by recurrent seizures caused by abnormal electrical activity in the brain. Partial-onset seizures, also known as focal seizures, originate in a specific area of the brain and may or may not spread to other regions (secondary generalisation). These seizures represent the most common type of epilepsy in adults, affecting approximately 60% of all people with the condition. Managing focal seizures effectively is crucial because poorly controlled seizures can significantly impact quality of life, safety, and cognitive function.
Brivaracetam belongs to a class of antiepileptic drugs known as synaptic vesicle protein 2A (SV2A) ligands. The SV2A protein is a transmembrane glycoprotein found on the surface of synaptic vesicles at presynaptic nerve terminals throughout the brain. When brivaracetam binds to SV2A, it modulates the release of neurotransmitters from these vesicles, thereby reducing the excessive neuronal firing that underlies seizure activity. This mechanism is distinct from many other antiepileptic drugs, which typically work by blocking sodium channels, enhancing GABAergic inhibition, or modulating calcium channels.
What sets brivaracetam apart from its chemical relative levetiracetam is its significantly higher affinity for the SV2A target. Studies have demonstrated that brivaracetam has approximately 15 to 30 times greater binding affinity for SV2A compared to levetiracetam. This higher affinity allows brivaracetam to achieve therapeutic effects at comparatively lower doses and may also contribute to a potentially different side-effect profile. Brivaracetam has also been shown to have a more rapid onset of action, reaching peak plasma concentrations within approximately one hour of oral administration.
Brivaracetam STADA is a generic formulation of the originator product Briviact (UCB Pharma). As a generic medicine, it contains the same active substance in the same amount and pharmaceutical form, and has demonstrated bioequivalence to the originator product through appropriate clinical studies. This means that Brivaracetam STADA is expected to have the same therapeutic effect and safety profile as the reference product, while potentially offering a more cost-effective treatment option for patients and healthcare systems.
Brivaracetam STADA is always used as an add-on treatment together with other antiepileptic medicines. It is not intended to replace your existing epilepsy medication but rather to supplement it for better seizure control. Your doctor will determine the most appropriate combination of medicines for your individual needs.
What Should You Know Before Taking Brivaracetam STADA?
Before taking Brivaracetam STADA, inform your doctor about all other medicines you take, any liver or kidney problems, history of depression or suicidal thoughts, and whether you are pregnant, planning to become pregnant, or breastfeeding. The medicine is contraindicated in patients with known hypersensitivity to brivaracetam or other pyrrolidone derivatives.
Contraindications
Brivaracetam STADA must not be taken if you are allergic (hypersensitive) to brivaracetam, other pyrrolidone derivatives (such as levetiracetam or piracetam), or any of the other ingredients in this medicine. If you are unsure whether you have an allergy to any pyrrolidone derivative, consult your doctor or pharmacist before starting treatment. An allergic reaction may manifest as skin rash, itching, swelling of the face, lips, tongue or throat, or difficulty breathing.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Brivaracetam STADA in several important situations. Firstly, if you have liver problems, your doctor may need to prescribe a lower dose, as the medicine is extensively metabolised in the liver. For patients with moderate to severe hepatic impairment (Child-Pugh Class B or C), the maximum recommended daily dose is 150 mg, and dosage adjustments may be necessary. Renal impairment does not generally require dose adjustment, although the medicine is not recommended in patients with end-stage renal disease undergoing dialysis due to limited data.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic drugs, including brivaracetam. A meta-analysis of randomised, placebo-controlled trials of antiepileptic drugs found a slightly increased risk of suicidal ideation and behaviour. The mechanism of this risk is not fully understood, and the available data do not exclude the possibility of an increased risk for brivaracetam specifically. Patients and caregivers should be informed of this potential risk and advised to seek immediate medical attention if signs of suicidal ideation or behaviour emerge. These may include new or worsening depression, anxiety, agitation, irritability, hostility, impulsivity, or unusual changes in mood or behaviour.
Dizziness and somnolence are among the most frequently reported side effects of brivaracetam. These effects can increase the risk of accidental injury, particularly in elderly patients. Caution is advised when getting up from a sitting or lying position, and patients should avoid activities requiring full alertness, such as driving or operating heavy machinery, until they understand how the medicine affects them individually.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking Brivaracetam STADA. The use of brivaracetam during pregnancy is generally not recommended unless clearly necessary. Animal studies have indicated potential reproductive toxicity, including increased embryofetal mortality and reduced fetal body weights at doses associated with maternal toxicity. However, there are limited clinical data on the use of brivaracetam in pregnant women.
It is important to understand that epilepsy itself, and particularly uncontrolled seizures, pose significant risks during pregnancy for both the mother and the developing baby. Tonic-clonic seizures during pregnancy can lead to maternal falls, fetal hypoxia, and in severe cases, maternal or fetal death. Therefore, the decision to continue or discontinue antiepileptic medication during pregnancy must be carefully weighed by your doctor, balancing the risks of untreated seizures against the potential risks of drug exposure to the fetus.
Women of childbearing potential should discuss effective contraception with their doctor. Brivaracetam does not significantly affect the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel), so hormonal contraceptives are expected to remain effective during treatment. However, it is still advisable to discuss family planning and contraceptive choices with your healthcare provider.
It is not known whether brivaracetam or its metabolites are excreted in human breast milk, although animal studies have shown excretion in milk. A decision must be made whether to discontinue breastfeeding or to discontinue brivaracetam therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Discuss this carefully with your doctor.
Driving and Using Machines
Brivaracetam may have a moderate influence on the ability to drive and use machines. Brivaracetam may cause dizziness, somnolence, and visual disturbances, which can impair your reaction time and coordination. Patients are advised not to drive or operate machinery until they are familiar with how the medicine affects their individual performance. It is worth noting that epilepsy itself may restrict a patient's ability to drive in many countries, so it is important to check local regulations regarding driving with epilepsy.
How Does Brivaracetam STADA Interact with Other Drugs?
Brivaracetam STADA can interact with several medications including carbamazepine, phenytoin, rifampicin, and phenobarbital. It is a substrate of CYP2C19 and may be affected by strong inhibitors or inducers of this enzyme. Tell your doctor about all medicines you are taking, including over-the-counter products and herbal remedies.
Brivaracetam is primarily metabolised in the liver through hydrolysis (by amidase enzymes) and secondarily through hydroxylation by the cytochrome P450 enzyme CYP2C19. It is also a weak inhibitor of CYP2C19. These metabolic pathways create the potential for pharmacokinetic drug interactions with other medicines that are metabolised by or affect the same enzymes. Understanding these interactions is essential for safe and effective use of brivaracetam, especially given that patients with epilepsy typically take multiple antiepileptic drugs simultaneously.
When brivaracetam is co-administered with strong enzyme inducers such as rifampicin (a powerful CYP3A4 and CYP2C19 inducer), the plasma levels of brivaracetam can be significantly reduced. Studies have shown that rifampicin can decrease brivaracetam plasma concentrations by approximately 45%. This reduction may lead to decreased efficacy of seizure control. If rifampicin or other strong enzyme inducers are started or stopped during brivaracetam treatment, your doctor may need to adjust the brivaracetam dose accordingly.
Major Interactions
| Drug | Effect on Brivaracetam | Effect on Other Drug | Clinical Action |
|---|---|---|---|
| Carbamazepine | Decreases brivaracetam plasma levels by ~26% | Increases carbamazepine-epoxide (active metabolite) by ~22% | No dose adjustment generally needed; monitor for carbamazepine-epoxide toxicity (dizziness, diplopia, ataxia) |
| Phenytoin | Decreases brivaracetam plasma levels by ~21% | Increases phenytoin plasma levels by ~20% | Phenytoin dose adjustment may be needed; monitor phenytoin levels |
| Rifampicin | Decreases brivaracetam plasma levels by ~45% | No significant effect | Consider increasing brivaracetam dose; closely monitor seizure control |
| Phenobarbital / Primidone | May decrease brivaracetam plasma levels | No significant effect expected | Monitor seizure control; dose adjustment may be considered |
Minor Interactions
Brivaracetam has a relatively low potential for clinically significant pharmacokinetic interactions with most other commonly used antiepileptic drugs. Studies have shown no clinically relevant interactions with the following medications:
- Levetiracetam: No pharmacokinetic interaction, but co-administration is generally not recommended due to the shared mechanism of action (SV2A binding). Adding brivaracetam to levetiracetam is unlikely to provide additional therapeutic benefit
- Valproate: No clinically significant interaction. Valproate does not significantly affect brivaracetam plasma levels
- Lamotrigine: No clinically significant pharmacokinetic interaction. No dose adjustment required
- Topiramate: No clinically significant interaction. Both can be used together without dose modification
- Oral contraceptives: Brivaracetam does not affect the efficacy of hormonal contraceptives containing ethinylestradiol and levonorgestrel
Regarding alcohol, patients should be advised that brivaracetam may enhance the effects of alcohol on psychomotor function, balance, and alertness. It is generally recommended that patients avoid alcohol or limit intake while taking brivaracetam to minimise the risk of CNS-depressant effects.
Always inform your doctor about all medicines you are currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements. Some herbal products, such as St. John's wort (Hypericum perforatum), can induce hepatic enzymes and potentially reduce brivaracetam levels, leading to decreased seizure control.
What Is the Correct Dosage of Brivaracetam STADA?
The recommended starting dose for adults and adolescents (16 years and older) weighing 50 kg or more is 50 mg twice daily (100 mg/day). The dose may be adjusted between 25 mg twice daily (50 mg/day) and 100 mg twice daily (200 mg/day) depending on individual response. For children aged 2 to 16 years, dosing is based on body weight.
Brivaracetam STADA should always be taken exactly as your doctor has instructed. The tablets should be swallowed whole with a glass of water and can be taken with or without food. The daily dose should be divided into two equal doses taken approximately 12 hours apart, morning and evening, to maintain stable plasma levels throughout the day. Consistent timing of doses helps ensure optimal seizure control.
Adults and Adolescents (16 years and older, weighing 50 kg or more)
Standard Adult Dosing
Starting dose: 50 mg twice daily (total 100 mg/day)
Dose range: 25 mg to 100 mg twice daily (total 50-200 mg/day)
Maximum dose: 200 mg/day
Your doctor may start you on a lower dose and gradually increase it based on your response and tolerability. In some clinical settings where rapid attainment of therapeutic plasma concentrations is needed, treatment may be initiated with a single loading dose of 100 mg, followed by the maintenance dose of 50 mg twice daily starting 12 hours later.
Children (2 to 16 years, or adolescents under 50 kg)
Paediatric Dosing (Weight-Based)
Dosing in children is based on body weight. Your doctor will calculate the appropriate dose for your child.
| Body Weight | Starting Dose | Maximum Dose |
|---|---|---|
| 10 kg to < 20 kg | 0.5-1 mg/kg twice daily | 2.5 mg/kg twice daily (max 5 mg/kg/day) |
| 20 kg to < 50 kg | 0.5-1 mg/kg twice daily | 2 mg/kg twice daily (max 4 mg/kg/day) |
| 50 kg or more | 25-50 mg twice daily | 100 mg twice daily (200 mg/day) |
Elderly
No dose adjustment is generally required for elderly patients (65 years and older) with normal kidney and liver function. However, clinical experience in elderly patients over the age of 65 is limited. As older patients may be more susceptible to side effects such as dizziness and somnolence, which increase the risk of falls, caution is recommended. Your doctor may start with a lower dose and increase it gradually, monitoring for adverse effects. Co-existing medical conditions and other medications commonly used in elderly patients should also be taken into account when determining the appropriate dose.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for the one you missed. If you are unsure about what to do, consult your doctor or pharmacist. Maintaining a regular dosing schedule is important for consistent seizure control, so consider using reminders or pill organisers to help you remember your doses.
Overdose
If you take more Brivaracetam STADA than prescribed, contact your doctor or go to your nearest hospital emergency department immediately. Symptoms of overdose may include dizziness, somnolence, nausea, and vertigo. There is limited clinical experience with brivaracetam overdose in humans, but doses up to 1400 mg have been reported without serious life-threatening effects. Treatment of overdose is supportive, and haemodialysis is not expected to significantly enhance clearance of brivaracetam due to its moderate protein binding and relatively low renal excretion of unchanged drug.
Never stop taking Brivaracetam STADA without consulting your doctor, even if you feel well. Abrupt discontinuation of antiepileptic drugs can lead to a rebound increase in seizure frequency and severity, which can be dangerous. If it is necessary to stop treatment, your doctor will advise you on how to reduce the dose gradually, typically over at least one week.
What Are the Side Effects of Brivaracetam STADA?
The most common side effects of Brivaracetam STADA are somnolence (sleepiness) and dizziness, affecting more than 1 in 10 patients. Other common side effects include fatigue, nausea, and upper respiratory tract infections. Serious but rare side effects include suicidal ideation, severe skin reactions, and neutropenia.
Like all medicines, Brivaracetam STADA can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity and tend to decrease as the body adjusts to the medication, typically within the first few weeks of treatment. The side effects listed below are based on data from clinical trials involving thousands of patients and from post-marketing surveillance. If you experience any side effects that concern you, or if they persist or worsen, talk to your doctor, pharmacist, or nurse.
Very Common Side Effects
- Somnolence (sleepiness or excessive drowsiness)
- Dizziness (a sensation of spinning or unsteadiness)
Common Side Effects
- Fatigue (feeling tired or lacking energy)
- Nausea (feeling sick)
- Vertigo (a sensation that the room is spinning)
- Insomnia (difficulty sleeping)
- Upper respiratory tract infections (common cold, flu-like symptoms)
- Depression
- Irritability
- Anxiety
- Decreased appetite
- Vomiting
- Constipation
Uncommon Side Effects
- Suicidal ideation (thoughts about suicide)
- Psychotic symptoms (hallucinations, paranoia)
- Aggression or agitation
- Neutropenia (low white blood cell count)
- Abnormal behaviour
Rare Side Effects
- Suicide attempt
- Severe allergic reactions (angioedema, bronchospasm)
- Severe skin reactions
Psychiatric side effects deserve particular attention. In clinical trials, psychiatric adverse events including depression, anxiety, irritability, and insomnia were reported in a proportion of patients. While most of these events were mild to moderate, some patients experienced more severe psychiatric reactions including suicidal ideation. The overall incidence of suicidal ideation in clinical trials was low, but patients and their families should remain vigilant for any changes in mood or behaviour and report these to their healthcare provider promptly.
It is important to note that some side effects may be related to the underlying epilepsy condition or to concomitant antiepileptic medications rather than to brivaracetam itself. Distinguishing between drug-related side effects and disease-related symptoms can sometimes be challenging. Your doctor will help you evaluate any new symptoms in the context of your overall treatment plan.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed here. You can also report side effects directly to your national pharmacovigilance authority (e.g., the Yellow Card Scheme in the UK, MedWatch in the USA, or the corresponding system in your country). By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Brivaracetam STADA?
Store Brivaracetam STADA below 30°C in the original packaging to protect from light and moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the package.
Proper storage of Brivaracetam STADA is important to ensure the medicine remains safe and effective throughout its shelf life. Store the tablets at a temperature not exceeding 30 degrees Celsius (86 degrees Fahrenheit). Keep the tablets in the original blister packaging until ready to take them, as this protects them from light and moisture, which can degrade the active substance over time.
Do not store Brivaracetam STADA in the bathroom, near a kitchen sink, or in other damp, warm places. High humidity and fluctuating temperatures can compromise the stability of the film coating and the active ingredient. Avoid transferring tablets to other containers unless they are specifically designed for medicine storage with adequate sealing.
Keep this medicine out of the sight and reach of children. Children may be attracted to the appearance of film-coated tablets, and accidental ingestion can be dangerous. Consider storing the medicine in a locked cabinet or at a height that is inaccessible to young children.
Do not use Brivaracetam STADA after the expiry date which is stated on the carton and blister pack after "EXP". The expiry date refers to the last day of that month. Using expired medicines may result in reduced efficacy or, in some cases, could pose a safety risk.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Pharmaceutical waste can contaminate water supplies and harm aquatic ecosystems, so proper disposal through designated pharmaceutical waste collection points is strongly recommended.
What Does Brivaracetam STADA Contain?
Each film-coated tablet of Brivaracetam STADA 10 mg contains 10 mg of brivaracetam as the active substance. The tablets also contain several inactive ingredients (excipients) that serve as fillers, binders, and coating agents to ensure proper tablet formation and stability.
The active substance in Brivaracetam STADA is brivaracetam, present at a dose of 10 mg per film-coated tablet. Brivaracetam is a chemical derivative of 2-pyrrolidinone and is chemically related to levetiracetam and piracetam, although it possesses distinct pharmacological properties due to its higher affinity for the SV2A binding site.
The other ingredients (excipients) typically found in brivaracetam film-coated tablets include:
- Tablet core: Croscarmellose sodium (a disintegrant that helps the tablet break down in the gastrointestinal tract), microcrystalline cellulose (a filler and binder), lactose monohydrate (a filler), and magnesium stearate (a lubricant that prevents the tablet from sticking during manufacturing)
- Film coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol (polyethylene glycol), and talc. The coating provides protection against moisture and light, improves the tablet's appearance, and makes it easier to swallow
If you have a known allergy or intolerance to lactose, you should discuss this with your doctor or pharmacist, as the tablets contain lactose monohydrate. While the amount of lactose in each tablet is small, it may be sufficient to cause symptoms in patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Patients with these conditions should not take this medicine.
Frequently Asked Questions About Brivaracetam STADA
Brivaracetam STADA is used as adjunctive (add-on) therapy for the treatment of partial-onset seizures (focal seizures), with or without secondary generalisation, in adults, adolescents, and children from 2 years of age with epilepsy. It works by binding to synaptic vesicle protein 2A (SV2A) in the brain, which helps to reduce seizure activity. It is always used alongside other antiepileptic medicines rather than as a standalone treatment.
Brivaracetam STADA is generally not recommended during pregnancy unless clearly necessary. Animal studies have shown some reproductive toxicity. Women of childbearing potential should discuss effective contraception with their doctor. If you become pregnant or plan to become pregnant while taking this medicine, consult your doctor immediately. Do not stop taking the medication without medical advice, as uncontrolled seizures can also harm both mother and baby.
The most common side effects of Brivaracetam STADA (affecting more than 1 in 10 patients) include somnolence (sleepiness) and dizziness. Common side effects (affecting up to 1 in 10 patients) include fatigue, nausea, vertigo, insomnia, depression, irritability, anxiety, decreased appetite, vomiting, constipation, and upper respiratory tract infections. Most side effects are mild to moderate and tend to decrease over time as the body adjusts.
Brivaracetam STADA can cause dizziness and somnolence (sleepiness), which may impair your ability to drive or operate machinery. You should not drive or use machines until you know how the medicine affects you. Additionally, epilepsy itself may restrict your ability to drive in many countries, so check local regulations.
If you miss a dose of Brivaracetam STADA, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Maintaining consistent dosing is important for stable seizure control, so consider using reminders or pill organisers to help you remember your doses.
No, you should not stop taking Brivaracetam STADA suddenly without consulting your doctor. Abrupt withdrawal of antiepileptic drugs can lead to an increase in seizure frequency and severity, which can be dangerous. If it is necessary to stop treatment, your doctor will advise you on how to gradually reduce the dose over at least one week to minimise the risk of breakthrough seizures.
References
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- Klitgaard H, Matagne A, Nicolas JM, et al. Brivaracetam: Rationale for discovery and preclinical profile of a selective SV2A ligand for epilepsy treatment. Epilepsia. 2016;57(4):538-548. doi:10.1111/epi.13340
- Klein P, Schiemann J, Sperling MR, et al. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015;56(12):1890-1898.
- Ryvlin P, Werhahn KJ, Blaszczyk B, et al. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014;55(1):47-56.
- International League Against Epilepsy (ILAE). Classification of the Epilepsies: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(4):512-521.
- World Health Organization (WHO). Epilepsy: Key Facts. Last updated 2024. Available at: who.int/news-room/fact-sheets/detail/epilepsy
- U.S. Food and Drug Administration (FDA). Briviact (brivaracetam) Prescribing Information. Reference ID: 4750022. Available at: accessdata.fda.gov
- British National Formulary (BNF). Brivaracetam. National Institute for Health and Care Excellence (NICE). Last updated 2025.
- Brodie MJ, Besag F, Ettinger AB, et al. Epilepsy, Antiepileptic Drugs, and Aggression: An Evidence-Based Review. Pharmacological Reviews. 2016;68(3):563-602.
- Stockis A, Watanabe S, Scheen AJ. Effect of brivaracetam on CYP2C19 activity as measured by omeprazole pharmacokinetics. Drug Metabolism and Disposition. 2015;43(11):1768-1773.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of specialist physicians with expertise in neurology, clinical pharmacology, and epilepsy management.
All content is reviewed according to international guidelines including the European Medicines Agency (EMA) SmPC, FDA prescribing information, ILAE classification guidelines, and WHO recommendations. Evidence level: 1A based on systematic reviews and randomised controlled trials.
iMedic follows the GRADE evidence framework. All medical claims are supported by peer-reviewed research. No commercial funding or pharmaceutical company sponsorship influences our content. Read more about our editorial standards.