Brivaracetam Zentiva: Uses, Dosage & Side Effects
A selective SV2A ligand antiepileptic drug used as adjunctive therapy for partial-onset (focal) seizures in patients with epilepsy
Brivaracetam Zentiva is a prescription antiepileptic medication containing brivaracetam, a selective, high-affinity synaptic vesicle protein 2A (SV2A) ligand. It is used as adjunctive (add-on) therapy for the treatment of partial-onset (focal) seizures with or without secondary generalization in adults, adolescents, and children from 2 years of age with epilepsy. Brivaracetam works by binding to SV2A on synaptic vesicles in the brain, modulating neurotransmitter release to reduce neuronal hyperexcitability and suppress seizure activity. Available as 10 mg film-coated tablets, Brivaracetam Zentiva is typically taken twice daily and has demonstrated significant efficacy in reducing seizure frequency in pivotal clinical trials, with a generally well-tolerated safety profile.
Quick Facts: Brivaracetam Zentiva
Key Takeaways
- Brivaracetam Zentiva is a next-generation antiepileptic drug that selectively targets synaptic vesicle protein 2A (SV2A) with 15–30 times higher affinity than levetiracetam, offering potent seizure control at lower doses.
- It is approved as adjunctive therapy for partial-onset (focal) seizures in patients aged 2 years and older, with clinical trials showing significant reductions in seizure frequency compared to placebo.
- Brivaracetam is rapidly and completely absorbed after oral administration, with near-100% bioavailability and a half-life of approximately 9 hours, supporting convenient twice-daily dosing.
- The most common side effects are drowsiness, dizziness, and fatigue, which are generally mild to moderate and often improve with continued treatment.
- Brivaracetam should never be stopped abruptly due to the risk of increased seizure frequency; dose reduction should always be gradual under medical supervision.
What Is Brivaracetam Zentiva and What Is It Used For?
Brivaracetam Zentiva contains the active substance brivaracetam, a novel antiepileptic drug (AED) that belongs to the racetam class of compounds. Unlike many older antiepileptic medications that were originally developed for other conditions and later found to have anticonvulsant properties, brivaracetam was specifically designed and developed as a high-affinity, selective ligand for synaptic vesicle protein 2A (SV2A). This targeted approach to drug development has resulted in a medication with a well-defined mechanism of action and a favorable pharmacological profile for the treatment of epilepsy.
SV2A is a transmembrane glycoprotein found on the surface of synaptic vesicles in presynaptic nerve terminals throughout the brain. Synaptic vesicles are the small membrane-bound compartments that store neurotransmitters and release them into the synaptic cleft when a nerve impulse arrives at the terminal. SV2A plays a critical role in regulating this process of neurotransmitter release, particularly in modulating the amount of neurotransmitter available for release and the timing of vesicle fusion with the presynaptic membrane. By binding to SV2A with high selectivity and affinity, brivaracetam modulates the release of neurotransmitters from hyperexcitable neurons, thereby reducing the likelihood of synchronized, abnormal neuronal firing that underlies seizure activity.
Brivaracetam has approximately 15 to 30 times higher binding affinity for SV2A compared to levetiracetam, its structural relative that was the first clinically used SV2A ligand. This enhanced affinity translates into several potential clinical advantages: brivaracetam can achieve therapeutic effects at lower doses, it penetrates the blood-brain barrier more rapidly (reaching the brain within minutes of administration), and it may have a more favorable side effect profile, particularly with respect to behavioral and psychiatric adverse effects. In preclinical studies, brivaracetam demonstrated broader and more potent anticonvulsant activity than levetiracetam across a range of seizure models, including audiogenic seizures, corneal kindling, and 6 Hz seizure models.
Brivaracetam Zentiva is indicated for use as adjunctive (add-on) therapy in the treatment of partial-onset seizures, also known as focal seizures, with or without secondary generalization. This means it is taken alongside one or more other antiepileptic medications to provide additional seizure control. Focal seizures originate in a specific area of one hemisphere of the brain and may remain localized (simple or complex partial seizures) or may spread to involve both hemispheres, resulting in secondary generalization (a tonic-clonic seizure). Focal seizures are the most common seizure type in adults with epilepsy, affecting approximately 60% of all people with the condition.
The efficacy of brivaracetam as adjunctive therapy was established in three pivotal phase III, randomized, double-blind, placebo-controlled clinical trials involving a total of more than 1,550 adult patients with uncontrolled focal seizures despite treatment with one or two concomitant antiepileptic drugs:
- Study N01252 (Phase III): This trial randomized 768 patients to receive brivaracetam 50 mg/day, 100 mg/day, or placebo. The 100 mg/day dose demonstrated a statistically significant 22.8% reduction in focal seizure frequency over the 12-week treatment period compared to a 0.4% reduction with placebo (p<0.001). The 50% responder rate (proportion of patients achieving at least a 50% reduction in seizure frequency) was 32.7% for brivaracetam 100 mg/day versus 16.7% for placebo.
- Study N01253 (Phase III): This trial enrolled 768 patients randomized to brivaracetam 5 mg/day, 50 mg/day, or placebo. Brivaracetam 50 mg/day showed a median percent reduction of 12.8% over placebo in focal seizure frequency, with a 50% responder rate of 32.0% compared to 21.6% for placebo.
- Study N01358 (Phase III): This trial randomized 480 patients to receive brivaracetam 100 mg/day, 200 mg/day, or placebo. Both doses achieved statistically significant reductions in focal seizure frequency: 24.4% for the 100 mg/day group and 24.0% for the 200 mg/day group compared to placebo. The 50% responder rates were 38.9% and 37.8% for the two dose groups, respectively, compared to 21.6% for placebo.
Long-term open-label extension studies have demonstrated sustained efficacy over periods of up to 8 years, with many patients continuing to experience seizure reductions and some achieving seizure freedom. Brivaracetam was first approved by the European Medicines Agency (EMA) in January 2016 under the brand name Briviact, and subsequently by the U.S. Food and Drug Administration (FDA) in February 2016. Brivaracetam Zentiva is a generic formulation manufactured by Zentiva that contains the same active substance at demonstrated bioequivalence.
Focal (partial-onset) seizures begin in a specific area of the brain. They can manifest in many ways depending on which brain region is affected: motor symptoms (involuntary jerking or stiffening), sensory symptoms (unusual sensations, visual disturbances), autonomic symptoms (changes in heart rate, sweating), or altered awareness. When focal seizures spread to involve both brain hemispheres, they become bilateral tonic-clonic seizures (previously called secondary generalization). Brivaracetam targets all these types of focal seizures.
What Should You Know Before Taking Brivaracetam Zentiva?
Contraindications
The primary contraindication to Brivaracetam Zentiva is hypersensitivity (allergy) to brivaracetam, to other pyrrolidone derivatives (such as piracetam or levetiracetam), or to any of the excipients in the formulation. The excipients in the 10 mg film-coated tablets include croscarmellose sodium, lactose monohydrate, and magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc in the film coating. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine due to the lactose content.
While there are few absolute contraindications beyond hypersensitivity, there are several important conditions and circumstances that require careful evaluation and discussion with a healthcare provider before starting brivaracetam therapy. These are detailed in the warnings and precautions section below.
Warnings and Precautions
Antiepileptic drugs, including brivaracetam, have been associated with an increased risk of suicidal thoughts and behavior. A meta-analysis conducted by the FDA found that patients treated with antiepileptic drugs had approximately twice the risk of suicidal ideation or behavior compared to placebo. Patients, caregivers, and families should be alert to the emergence or worsening of depression, suicidal thoughts, unusual changes in mood or behavior, and should seek medical advice immediately if such symptoms occur.
Before starting Brivaracetam Zentiva, discuss the following with your healthcare provider:
- Depression and psychiatric disorders: Brivaracetam can cause psychiatric adverse reactions, including irritability, anxiety, agitation, depression, aggression, and, in rare cases, psychotic symptoms and suicidal ideation. Patients with a history of psychiatric disorders are at higher risk and should be closely monitored. If new or worsening psychiatric symptoms develop during treatment, consult your doctor promptly. While brivaracetam may have a more favorable psychiatric profile than levetiracetam, vigilance is still required.
- Liver disease: Brivaracetam is primarily metabolized in the liver. Patients with hepatic impairment (Child-Pugh A, B, or C) may have increased plasma levels of brivaracetam. A maximum daily dose of 150 mg is recommended for patients with any stage of hepatic impairment. Liver function should be assessed before starting treatment and monitored periodically.
- Dizziness and drowsiness: Brivaracetam can cause dizziness and somnolence, which may affect the ability to drive or operate machinery. Patients should be advised not to drive or operate dangerous machinery until they are familiar with the effects of the medication on their individual response. These effects are most common during dose initiation and titration.
- Abrupt withdrawal: As with all antiepileptic drugs, brivaracetam should not be stopped suddenly. Abrupt discontinuation can lead to an increase in seizure frequency, potentially including status epilepticus, which is a medical emergency requiring immediate treatment. If discontinuation is necessary, the dose should be reduced gradually over at least one week.
Children and Adolescents
Brivaracetam is approved for use as adjunctive therapy in children and adolescents aged 2 years and older for the treatment of focal seizures. The dosage in pediatric patients is based on body weight, and an appropriate formulation (oral solution) may be used for children who cannot swallow tablets. The safety and efficacy of brivaracetam in children under 2 years of age have not been established, and it is not recommended for use in this age group. Clinical studies in pediatric patients have confirmed that brivaracetam is effective in reducing focal seizure frequency, with a safety profile consistent with that observed in adults.
Pregnancy and Breastfeeding
Brivaracetam should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment. All antiepileptic drugs carry some degree of teratogenic risk, and the management of epilepsy during pregnancy requires careful balancing of the risks of medication exposure against the risks of uncontrolled seizures, which include physical injury to the mother, fetal hypoxia, and an increased risk of miscarriage or stillbirth.
Animal reproductive studies with brivaracetam have shown some developmental toxicity at doses higher than those used clinically, including reduced fetal body weight and increased skeletal variations, but no major malformations. However, animal studies are not always predictive of human response. There are limited data from the use of brivaracetam in pregnant women. Women who become pregnant while taking brivaracetam should contact their healthcare provider immediately to discuss the best course of action. Enrolling in a pregnancy registry for antiepileptic drugs can help contribute to the knowledge base about the safety of these medications during pregnancy.
Brivaracetam is excreted in human breast milk. The concentration of brivaracetam in breast milk is expected to be similar to maternal plasma levels, given its low protein binding (approximately 20%). A risk to the breastfed infant cannot be excluded. The decision whether to discontinue breastfeeding or discontinue brivaracetam therapy should be made in consultation with the healthcare provider, taking into account the importance of the drug to the mother and the potential effects on the infant.
Driving and Operating Machinery
Brivaracetam may have a moderate influence on the ability to drive and use machines. Dizziness and somnolence are among the most commonly reported side effects and may impair reaction time and concentration. Patients should not drive, operate heavy machinery, or engage in other potentially hazardous activities until they have sufficient experience with brivaracetam to gauge whether it adversely affects their mental or motor performance. In many jurisdictions, there are also legal requirements regarding driving and epilepsy that patients should be aware of, independent of the effects of medication.
How Does Brivaracetam Zentiva Interact with Other Drugs?
Brivaracetam is primarily metabolized by hydrolysis via amidase enzymes, with a secondary metabolic pathway involving CYP2C19-mediated hydroxylation. It is a weak inhibitor of CYP2C19 and does not significantly induce or inhibit other major cytochrome P450 enzymes at clinically relevant concentrations. This metabolic profile means that brivaracetam has a relatively favorable drug interaction profile compared to many older antiepileptic drugs that are potent enzyme inducers or inhibitors. Nevertheless, there are some clinically important interactions to be aware of.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Rifampicin | Rifampicin (a potent enzyme inducer) can decrease brivaracetam plasma concentrations by approximately 45%, potentially reducing its antiepileptic efficacy. | If co-administration is necessary, consider increasing the brivaracetam dose. Monitor seizure control closely. |
| Carbamazepine | Brivaracetam may increase the plasma concentration of carbamazepine-epoxide (the active metabolite of carbamazepine) by up to 30%, without significantly affecting carbamazepine parent compound levels. | Monitor for signs of carbamazepine toxicity (dizziness, diplopia, ataxia, nausea). Carbamazepine dose adjustment may be necessary. |
| Phenytoin | Co-administration of brivaracetam can increase phenytoin plasma concentrations by approximately 20% due to inhibition of CYP2C19, a pathway involved in phenytoin metabolism. | Monitor phenytoin levels and adjust dose as needed. Watch for signs of phenytoin toxicity (nystagmus, ataxia, slurred speech). |
| Phenobarbital | Phenobarbital, as an enzyme inducer, may decrease brivaracetam plasma concentrations. Brivaracetam may also slightly increase phenobarbital levels. | Monitor seizure control and phenobarbital levels. Dose adjustments may be needed for both drugs. |
Minor Interactions and No Significant Interactions
Several commonly used medications and drug classes have been studied for interactions with brivaracetam, with no clinically significant effects found:
- Oral contraceptives: Brivaracetam at a dose of 100 mg/day does not significantly affect the pharmacokinetics of combined oral contraceptives (ethinylestradiol and levonorgestrel). This is an important advantage over many enzyme-inducing antiepileptic drugs (such as carbamazepine, phenytoin, and phenobarbital) that can reduce the effectiveness of hormonal contraception.
- Levetiracetam: While brivaracetam and levetiracetam both target SV2A, co-administration does not result in clinically significant pharmacokinetic interactions. However, because they share the same target, adding brivaracetam to a regimen that already includes levetiracetam may provide limited additional benefit, and some clinicians prefer to switch from levetiracetam to brivaracetam rather than using both concurrently.
- Midazolam: Brivaracetam does not significantly affect the pharmacokinetics of midazolam, suggesting it does not meaningfully inhibit or induce CYP3A4.
- Gemfibrozil: Gemfibrozil does not significantly affect brivaracetam plasma concentrations, indicating that inhibition of amidase or other metabolic pathways by gemfibrozil is not clinically relevant.
Brivaracetam can enhance the sedative effects of alcohol and other central nervous system (CNS) depressants, including benzodiazepines, opioids, and sedating antihistamines. Patients should be advised to limit or avoid alcohol consumption during brivaracetam therapy and to use caution when taking other CNS-depressant medications. The combination may increase the risk of drowsiness, dizziness, impaired coordination, and falls.
What Is the Correct Dosage of Brivaracetam Zentiva?
Brivaracetam Zentiva is administered orally, and the film-coated tablets should be swallowed whole with water. They may be taken with or without food, as food does not significantly affect the rate or extent of absorption. Consistent twice-daily dosing at approximately the same times each day is recommended to maintain stable plasma concentrations. The dose should be individualized based on clinical response and tolerability.
Adults and Adolescents (50 kg and Above)
Standard Adult Dosing
The recommended starting dose is 50 mg/day (25 mg twice daily). Based on individual patient response and tolerability, the dose may be adjusted within a range of 50 to 200 mg/day. Some clinicians may choose to start at 100 mg/day (50 mg twice daily) when rapid seizure control is needed, as therapeutic plasma levels can be achieved quickly due to brivaracetam's near-complete bioavailability and rapid absorption. The maximum recommended dose is 200 mg/day (100 mg twice daily).
| Patient Group | Starting Dose | Maintenance Range | Maximum Dose |
|---|---|---|---|
| Adults (≥18 years) | 50 mg/day (25 mg twice daily) | 50–200 mg/day | 200 mg/day |
| Adolescents ≥50 kg | 50 mg/day (25 mg twice daily) | 50–200 mg/day | 200 mg/day |
| Children 20–50 kg | 0.5–1 mg/kg twice daily | 1–2 mg/kg twice daily | 4 mg/kg/day (max 200 mg/day) |
| Children <20 kg (age ≥2) | 0.5–1 mg/kg twice daily | 1–2.5 mg/kg twice daily | 5 mg/kg/day |
| Hepatic impairment (all stages) | 25 mg twice daily | 50–150 mg/day | 150 mg/day |
Children (2 Years and Older)
In pediatric patients, the dose of brivaracetam is determined by body weight. For children weighing between 20 and 50 kg, the recommended starting dose is 0.5 to 1 mg/kg twice daily, with a maintenance dose of 1 to 2 mg/kg twice daily (maximum 4 mg/kg/day, not exceeding 200 mg/day). For children weighing less than 20 kg (but at least 2 years old), the starting dose is 0.5 to 1 mg/kg twice daily, with a maintenance dose of 1 to 2.5 mg/kg twice daily (maximum 5 mg/kg/day). An oral solution formulation is available for children who cannot swallow tablets. The 10 mg tablet strength available as Brivaracetam Zentiva may be particularly useful for achieving appropriate doses in lighter-weight patients.
Elderly Patients
No specific dose adjustment is required for elderly patients solely based on age. However, elderly patients may be more sensitive to the sedative effects of brivaracetam and may have age-related changes in hepatic and renal function that could affect drug metabolism and elimination. A lower starting dose and slower dose escalation may be prudent in elderly patients, particularly those with multiple comorbidities or taking multiple medications. Regular monitoring of clinical response and tolerability is recommended.
Missed Dose
If you miss a dose of Brivaracetam Zentiva, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for the one you missed. Taking a double dose may increase the risk of side effects, particularly drowsiness and dizziness. If you frequently forget to take your medication, consider setting a daily alarm or using a pill organizer to help maintain a consistent dosing schedule. Consistent adherence to the prescribed dosing regimen is essential for maintaining optimal seizure control.
Overdose
If you suspect an overdose of brivaracetam, seek immediate medical attention or contact your local poison control center. There is no specific antidote for brivaracetam overdose. Treatment is supportive, and hemodialysis can remove approximately 50% of the drug from the body.
Clinical experience with brivaracetam overdose in humans is limited. In a clinical study, a healthy volunteer who received a single dose of 1,400 mg (7 times the maximum recommended daily dose) experienced drowsiness, dizziness, nausea, and vertigo, all of which resolved without sequelae. In the event of overdose, standard medical support measures should be employed, including monitoring of vital signs, observation, and institution of supportive therapy as clinically indicated. Since brivaracetam is only approximately 20% bound to plasma proteins, hemodialysis is expected to be moderately effective in removing the drug, extracting approximately 50% of the dose over a 4-hour dialysis session.
What Are the Side Effects of Brivaracetam Zentiva?
Like all medicines, Brivaracetam Zentiva can cause side effects, although not everybody gets them. The safety profile of brivaracetam has been characterized through extensive clinical trials involving thousands of patients and through ongoing post-marketing surveillance. In clinical trials, the most common reasons for discontinuation due to adverse effects were dizziness (0.8%), somnolence (0.8%), and convulsion (0.8%).
The following frequency classification is used to describe how often side effects occur: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), and rare (affects fewer than 1 in 1,000 people).
Very Common
- Somnolence (drowsiness or excessive sleepiness)
- Dizziness
Common
- Fatigue (tiredness, lack of energy)
- Nausea
- Vomiting
- Insomnia (difficulty sleeping)
- Depression
- Anxiety
- Irritability
- Upper respiratory tract infections (cold, flu-like symptoms)
- Decreased appetite
- Constipation
- Vertigo (spinning sensation)
Uncommon
- Aggression
- Agitation
- Psychotic symptoms (hallucinations, paranoia)
- Suicidal ideation
- Neutropenia (low white blood cell count)
- Abnormal liver function tests
Rare
- Severe allergic reactions (angioedema, bronchospasm)
- Suicidal behavior or attempt
The sedative side effects of brivaracetam (somnolence and dizziness) are the most commonly reported adverse events and are typically dose-dependent. They tend to occur most frequently during the initial weeks of treatment and during dose escalation, and many patients find that these effects diminish over time as the body adjusts to the medication. Dose reduction may be considered if these effects are persistent or significantly impair daily functioning.
Psychiatric adverse effects deserve special attention. While brivaracetam is generally considered to have a more favorable psychiatric side effect profile compared to levetiracetam, it can still cause mood and behavioral changes in some patients. In clinical trials, the incidence of psychiatric adverse events was lower with brivaracetam than with levetiracetam when both were used as adjunctive therapy. However, patients with a history of psychiatric disorders should be closely monitored, and any new or worsening psychiatric symptoms should be promptly reported to the treating physician.
Neutropenia (a reduction in neutrophil white blood cells) has been reported uncommonly in clinical trials and post-marketing experience. In some cases, this has been associated with an increased risk of infection. Complete blood counts should be considered if a patient develops signs or symptoms of infection (such as fever, sore throat, or mouth ulcers) during brivaracetam therapy, particularly if these symptoms are recurrent or persistent.
Contact your healthcare provider or seek emergency care immediately if you experience: signs of a severe allergic reaction (swelling of the face, lips, tongue, or throat; difficulty breathing; widespread skin rash); thoughts of self-harm or suicide; severe mood changes; signs of severe infection (high fever, severe sore throat); or a significant increase in seizure frequency.
How Should You Store Brivaracetam Zentiva?
Proper storage of medications is essential to maintain their effectiveness and safety. Brivaracetam Zentiva film-coated tablets should be stored at room temperature, not exceeding 30°C (86°F). The tablets do not require refrigeration. They should be stored in the original packaging to protect them from moisture and light. Do not remove tablets from the blister pack until you are ready to take them.
Keep Brivaracetam Zentiva out of the sight and reach of children. Accidental ingestion by children could lead to serious adverse effects, including excessive sedation and respiratory depression. Store the medication in a secure location, and consider using a child-resistant storage container if the original packaging does not have this feature.
Do not use Brivaracetam Zentiva after the expiry date which is stated on the carton and blister after "EXP." The expiry date refers to the last day of that month. Do not use this medicine if you notice any visible signs of deterioration, such as discoloration of the tablets or damage to the blister packaging.
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 to protect the environment. In many countries, pharmacies and healthcare facilities offer take-back programs for unused or expired medications, ensuring they are disposed of safely and in an environmentally responsible manner.
What Does Brivaracetam Zentiva Contain?
Understanding the complete composition of your medication can be important, particularly if you have known allergies or intolerances to specific substances. Below is a breakdown of the active and inactive ingredients in Brivaracetam Zentiva 10 mg film-coated tablets.
Active Ingredient
Each film-coated tablet contains 10 mg of brivaracetam. Brivaracetam (chemical name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide) is a white to off-white crystalline powder with a molecular weight of 212.29 g/mol. It is freely soluble in water, which contributes to its rapid and complete absorption after oral administration.
Inactive Ingredients (Excipients)
Tablet core:
- Croscarmellose sodium: A disintegrant that helps the tablet break apart in the gastrointestinal tract for rapid drug release.
- Lactose monohydrate: A filler/binder used to give the tablet its size and shape. Note: patients with lactose intolerance should be aware of this ingredient.
- Magnesium stearate: A lubricant that prevents the tablet from sticking to manufacturing equipment during production.
Film coating:
- Polyvinyl alcohol: A film-forming agent that creates the protective coating.
- Titanium dioxide (E171): A white pigment used for coloring and opacity.
- Macrogol (polyethylene glycol): A plasticizer that makes the film coating flexible.
- Talc: An anti-adherent used in the coating process.
Brivaracetam Zentiva 10 mg film-coated tablets are white, round tablets. They are available in blister packs of various sizes. Not all pack sizes may be marketed in your country. The tablets should be swallowed whole and should not be crushed, chewed, or dissolved, as this may alter the rate of drug release and absorption.
Frequently Asked Questions About Brivaracetam Zentiva
Brivaracetam Zentiva is a prescription antiepileptic medication used as adjunctive (add-on) therapy for the treatment of partial-onset (focal) seizures with or without secondary generalization in patients aged 2 years and older with epilepsy. It is not used as a standalone treatment but rather in combination with other antiepileptic drugs to help patients achieve better seizure control when their current medication alone is not sufficient.
Both brivaracetam and levetiracetam work by targeting synaptic vesicle protein 2A (SV2A) in the brain, but brivaracetam has 15 to 30 times higher binding affinity for this target. This means brivaracetam can achieve therapeutic effects at lower doses and penetrates the brain more rapidly. Clinical evidence suggests that brivaracetam may have a more favorable psychiatric side effect profile, with potentially fewer issues related to irritability, aggression, and behavioral disturbance compared to levetiracetam. However, individual responses vary, and your neurologist will help determine which medication is most appropriate for you.
No, you should never stop taking brivaracetam suddenly without medical guidance. Abrupt discontinuation of antiepileptic drugs can lead to a dangerous increase in seizure frequency, potentially including status epilepticus (a prolonged seizure that is a medical emergency). If your doctor decides that you should stop taking brivaracetam, the dose will be reduced gradually over at least one week to minimize the risk of withdrawal seizures.
At the standard therapeutic dose of 100 mg per day, brivaracetam does not significantly interact with combined oral contraceptives containing ethinylestradiol and levonorgestrel. This is an important advantage over enzyme-inducing antiepileptic drugs such as carbamazepine, phenytoin, and phenobarbital, which can significantly reduce the effectiveness of hormonal contraception. However, always inform your healthcare provider about all medications you are taking, including contraceptives, to ensure your treatment plan is safe and effective.
Yes, Brivaracetam Zentiva film-coated tablets can be taken with or without food. Food does not significantly affect the rate or extent of brivaracetam absorption, so you can take the medication at mealtimes or on an empty stomach, whichever is more convenient. The most important thing is to take it consistently at approximately the same times each day, twice daily, to maintain stable blood levels and optimal seizure control.
Brivaracetam is rapidly absorbed after oral administration, reaching peak blood levels within approximately 1 hour. Due to its near-complete bioavailability and rapid brain penetration, therapeutic effects can begin shortly after starting treatment. In clinical trials, significant reductions in seizure frequency were observed within the first week of treatment at the full therapeutic dose. However, optimal seizure control may take several weeks to establish, and your doctor may need to adjust your dose during this period.
References
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- U.S. Food and Drug Administration (FDA). Briviact (brivaracetam) — Prescribing Information. Revised 2024. Available from: www.fda.gov
- Klein P, et al. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015;56(12):1890–1898. doi:10.1111/epi.13212
- Ryvlin P, 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. doi:10.1111/epi.12432
- Kwan P, et al. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: Results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial. Epilepsia. 2014;55(1):38–46. doi:10.1111/epi.12391
- Lattanzi S, et al. Brivaracetam add-on for refractory focal epilepsy: A systematic review and meta-analysis. Neurology. 2016;86(14):1344–1352. doi:10.1212/WNL.0000000000002545
- International League Against Epilepsy (ILAE). Updated classification and management of epilepsies. 2022. Available from: www.ilae.org
- National Institute for Health and Care Excellence (NICE). Epilepsies in children, young people and adults. NICE guideline [NG217]. Updated 2024. Available from: www.nice.org.uk
- World Health Organization (WHO). Model List of Essential Medicines — 23rd List, 2023. Available from: www.who.int
- Yates SL, et al. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy & Behavior. 2015;52(Pt A):165–168. doi:10.1016/j.yebeh.2015.09.005
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