Briviact 25mg Tablets
It is used to treat seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Synaptic vesicle protein 2A (SV2A) ligand
Pregnancy Category
Not available
FDA Approved
Feb 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Brivaracetam (Briviact) is a medication used to help control partial-onset seizures in people with epilepsy. It works by affecting certain proteins in the brain that are involved in nerve cell communication, which can help calm overactive brain signals that lead to seizures.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's essential to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's crucial to maintain your treatment schedule to ensure the best possible outcome.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent unauthorized access.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's essential to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's crucial to maintain your treatment schedule to ensure the best possible outcome.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent unauthorized access.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, with or without food.
- Do not stop taking this medication suddenly without talking to your doctor, as this can increase the risk of seizures.
- Avoid alcohol and other CNS depressants, as they can increase side effects like dizziness and sleepiness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and coordination problems.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 25 mg to 50 mg twice daily (50 mg to 100 mg/day), titrated to maintenance dose. Maintenance dose 25 mg to 100 mg twice daily (50 mg to 200 mg/day).
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
partial-onset seizures:
Initial 25 mg to 50 mg twice daily (50 mg to 100 mg/day). Based on individual patient tolerability and therapeutic response, the dose may be adjusted down to 25 mg twice daily (50 mg/day) or up to 100 mg twice daily (200 mg/day).
Pediatric Dosing
Neonatal:
Not established (approved for 1 month and older)
Infant:
1 month to < 17 years (weight-based dosing): 10 kg to < 20 kg: Initial 0.5 mg/kg twice daily (1 mg/kg/day); Target 0.5 to 2.5 mg/kg twice daily (1 to 5 mg/kg/day). Max 2.5 mg/kg twice daily (5 mg/kg/day).
Child:
1 month to < 17 years (weight-based dosing): 20 kg to < 50 kg: Initial 0.75 mg/kg twice daily (1.5 mg/kg/day); Target 0.75 to 2 mg/kg twice daily (1.5 to 4 mg/kg/day). Max 2 mg/kg twice daily (4 mg/kg/day).
Adolescent:
1 month to < 17 years (weight-based dosing): ≥ 50 kg: Initial 25 mg twice daily (50 mg/day); Target 25 to 100 mg twice daily (50 to 200 mg/day). Max 100 mg twice daily (200 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No dose adjustment needed. Hemodialysis removes brivaracetam; however, supplemental dosing is not required after dialysis.
Hepatic Impairment:
Mild:
Maximum recommended daily dose is 150 mg/day (75 mg twice daily).
Moderate:
Maximum recommended daily dose is 150 mg/day (75 mg twice daily).
Severe:
Maximum recommended daily dose is 100 mg/day (50 mg twice daily).
Pharmacology
Mechanism of Action
Brivaracetam exhibits a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain. The precise mechanism by which brivaracetam exerts its antiepileptic effect is not fully understood, but its binding to SV2A is thought to modulate neurotransmitter release, which may contribute to its anticonvulsant activity.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
0.5-2 hours
FoodEffect:
Food does not affect the extent of absorption, but may delay Tmax by 1 hour.
Distribution:
Vd:
0.5 L/kg
ProteinBinding:
<20%
CnssPenetration:
Yes
Elimination:
HalfLife:
9 hours
Clearance:
Not specified as a single rate, but total body clearance is approximately 3.4 L/h.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 34% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within days of reaching therapeutic levels (titration period)
PeakEffect:
Not directly measurable as a single time point for seizure control; related to steady-state concentrations.
DurationOfAction:
Related to half-life, requiring twice-daily dosing.
Confidence:
Medium
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Hallucinations (seeing or hearing things that are not there)
Changes in balance or coordination
Difficulty walking
Clumsiness
Inability to control eye movements
Suicidal thoughts or actions (especially in people with a history of suicidal thoughts or actions)
New or worsening symptoms of depression, such as:
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Changes in mood or behavior
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
Vomiting
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Hallucinations (seeing or hearing things that are not there)
Changes in balance or coordination
Difficulty walking
Clumsiness
Inability to control eye movements
Suicidal thoughts or actions (especially in people with a history of suicidal thoughts or actions)
New or worsening symptoms of depression, such as:
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Changes in mood or behavior
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
Vomiting
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression, anxiety, or irritability
- Thoughts about suicide or self-harm
- Unusual changes in mood or behavior (e.g., aggression, agitation, panic attacks)
- Severe skin rash or allergic reactions (e.g., swelling of face, lips, tongue, or throat; difficulty breathing)
- Dizziness, drowsiness, or problems with coordination that are severe or persistent
- Unexplained fever, sore throat, or other signs of infection (rare, but possible blood dyscrasias)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are undergoing dialysis, discuss this with your doctor.
This medication may interact with other medications or health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are undergoing dialysis, discuss this with your doctor.
This medication may interact with other medications or health conditions. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage to minimize potential risks.
This medication may cause changes in behavior, as well as mental or mood disturbances. If you experience any of these effects, discuss them with your doctor.
If your seizures change or worsen after starting this medication, notify your doctor promptly.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage to minimize potential risks.
This medication may cause changes in behavior, as well as mental or mood disturbances. If you experience any of these effects, discuss them with your doctor.
If your seizures change or worsen after starting this medication, notify your doctor promptly.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Somnolence (extreme sleepiness)
- Dizziness
- Nausea
- Vertigo
- Fatigue
- Diplopia (double vision)
- Ataxia (loss of coordination)
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include gastric lavage or activated charcoal if ingestion was recent. There is no specific antidote. Hemodialysis can remove brivaracetam.
Drug Interactions
Major Interactions
- Carbamazepine (may decrease brivaracetam plasma concentrations)
- Phenytoin (brivaracetam may increase phenytoin plasma concentrations)
- Phenobarbital (brivaracetam may increase phenobarbital plasma concentrations)
Moderate Interactions
- Rifampin (may decrease brivaracetam plasma concentrations)
- Oral contraceptives (brivaracetam does not significantly affect hormonal contraceptive levels)
Confidence Interactions
Monitoring
Baseline Monitoring
Seizure frequency and characteristics
Rationale: To establish baseline control and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Renal and hepatic function tests
Rationale: To guide dose adjustments in patients with impairment.
Timing: Prior to initiation of therapy, especially if impairment is suspected or known.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment (e.g., at follow-up visits)
Target: Reduction in seizure frequency or complete seizure freedom.
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Mental status and behavioral changes (e.g., mood, aggression, suicidal ideation)
Frequency: Regularly, especially during initial titration and dose changes.
Target: Stable mood and behavior.
Action Threshold: New or worsening depression, suicidal thoughts, aggression, or other unusual behavioral changes require immediate evaluation and potential dose adjustment or discontinuation.
Signs of hypersensitivity reactions (e.g., rash, angioedema)
Frequency: Regularly, especially during initial treatment.
Target: Absence of allergic reactions.
Action Threshold: Development of rash, swelling, or other signs of hypersensitivity requires immediate discontinuation.
Symptom Monitoring
- Dizziness
- Somnolence (sleepiness)
- Fatigue
- Nausea
- Vomiting
- Irritability
- Aggression
- Depression
- Anxiety
- Suicidal thoughts or behavior
- Coordination problems
- Balance difficulties
- Mood changes
- Psychotic symptoms (e.g., hallucinations)
- Skin rash
- Swelling of face, lips, tongue, or throat (angioedema)
Special Patient Groups
Pregnancy
Brivaracetam may cause fetal harm when administered to a pregnant woman. Animal studies have shown developmental toxicity (e.g., increased embryofetal mortality, reduced fetal weight, skeletal variations) at clinically relevant exposures. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Trimester-Specific Risks:
First Trimester:
Potential for major congenital malformations based on animal data. Human data are limited but suggest a possible increased risk of adverse pregnancy outcomes.
Second Trimester:
Potential for continued fetal exposure and developmental effects.
Third Trimester:
Potential for continued fetal exposure and developmental effects; consideration of neonatal withdrawal symptoms if discontinued abruptly.
Lactation
Brivaracetam is excreted into human breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for brivaracetam, and any potential adverse effects on the breastfed infant from brivaracetam or from the underlying maternal condition. Monitor breastfed infants for sedation, irritability, and poor feeding.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for adverse effects.
Pediatric Use
Approved for use in patients 1 month of age and older. Dosing is weight-based for patients 1 month to < 50 kg. Safety and effectiveness in pediatric patients younger than 1 month of age have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Brivaracetam is a newer generation antiepileptic drug (AED) with a high affinity for SV2A, similar to levetiracetam but with potentially faster onset and different side effect profile.
- It generally has a favorable pharmacokinetic profile with low protein binding and minimal CYP450 interactions, making it a good option for polytherapy.
- Rapid titration is possible, allowing for quicker achievement of therapeutic doses.
- Patients should be monitored for psychiatric and behavioral adverse reactions, including suicidal ideation, which are known class effects of AEDs.
- Can be used as adjunctive therapy for partial-onset seizures in a broad age range (1 month and older).
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Lamotrigine (Lamictal)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Phenytoin (Dilantin)
- Valproate (Depakote)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
Cost & Coverage
Average Cost:
Varies widely per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.