Briviact 50mg Tablets
It is used to treat seizures.
Drug Class
Antiepileptic Drug (AED)
Pharmacologic Class
Synaptic Vesicle Glycoprotein 2A (SV2A) Ligand
Pregnancy Category
Not available
FDA Approved
Sep 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Briviact is a medicine used to treat partial-onset seizures in people 1 month of age and older. It works by affecting certain proteins in the brain that are involved in seizure activity.
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 regimen 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 accidental ingestion or misuse.
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 or healthcare provider. 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 regimen 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 accidental ingestion or misuse.
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 or healthcare provider. 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
- Do not stop taking Briviact suddenly, as this can increase your risk of seizures. Always consult your doctor before making any changes to your dose.
- Briviact can cause dizziness, drowsiness, and problems with coordination. Avoid driving or operating machinery until you know how this medication affects you.
- Avoid or limit alcohol consumption while taking Briviact, as it can worsen side effects like dizziness and drowsiness.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 50 mg twice daily, may adjust based on individual patient response and tolerability. Maintenance dose typically 50 mg to 200 mg twice daily.
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
maxDose:
200 mg twice daily (400 mg/day)
Pediatric Dosing
Neonatal:
Not established (approved for 1 month and older)
Infant:
Oral solution/injection: 1 month to <4 years: 1 mg/kg twice daily (initial), target 1-2.5 mg/kg twice daily. Max 5 mg/kg twice daily.
Child:
Oral solution/injection: 4 years to <16 years: 1 mg/kg twice daily (initial), target 1-2.5 mg/kg twice daily. Max 5 mg/kg twice daily. Tablets: 16 years and older: Same as adult dosing.
Adolescent:
16 years and older: Same as adult dosing (50-200 mg twice daily).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
CrCl <30 mL/min: Max recommended dose 75 mg twice daily (150 mg/day).
Dialysis:
Patients on hemodialysis: Max recommended dose 75 mg twice daily (150 mg/day). Administer after dialysis session.
Hepatic Impairment:
Mild:
Max recommended dose 75 mg twice daily (150 mg/day).
Moderate:
Max recommended dose 75 mg twice daily (150 mg/day).
Severe:
Max recommended dose 50 mg twice daily (100 mg/day).
Pharmacology
Mechanism of Action
Brivaracetam exhibits a high and selective affinity for synaptic vesicle glycoprotein 2A (SV2A) in the brain. While the precise mechanism by which brivaracetam exerts its antiepileptic effects is not fully elucidated, its binding to SV2A is thought to modulate neurotransmitter release, which may contribute to its anticonvulsant activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 2 hours
FoodEffect:
Food does not affect the extent of absorption, but may delay Tmax slightly.
Distribution:
Vd:
Approximately 0.5 L/kg
ProteinBinding:
<20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 9 hours
Clearance:
Approximately 3.4 L/h (total body clearance)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 34% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 2-3 days of reaching steady state
DurationOfAction:
Maintained with twice-daily dosing due to half-life
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Uncontrolled 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
Vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. 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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Uncontrolled 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
Vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. 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:
- Unusual changes in mood or behavior (e.g., agitation, aggression, depression, anxiety)
- Thoughts of self-harm or suicide
- Severe dizziness or loss of coordination
- Unexplained rash or allergic reaction symptoms (e.g., swelling of face, lips, tongue)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
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 can interact with other drugs and health conditions. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
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 medication is suitable for your specific situation.
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 can interact with other drugs and health conditions. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
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 medication is suitable for your specific situation.
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:
- Drowsiness
- Dizziness
- Nausea
- Vertigo
- Balance disorder
- Diplopia (double vision)
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage or activated charcoal if recent ingestion.
Drug Interactions
Moderate Interactions
- Rifampin (may decrease brivaracetam levels)
- Carbamazepine (may increase carbamazepine epoxide levels)
- Phenytoin (may increase phenytoin levels at higher brivaracetam doses)
- Oral contraceptives (brivaracetam may decrease ethinyl estradiol and levonorgestrel levels)
Minor Interactions
- Alcohol (additive CNS depression)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To guide initial dosing in patients with severe renal impairment or ESRD.
Timing: Prior to initiation
Hepatic function (LFTs)
Rationale: To guide initial dosing in patients with hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
Seizure frequency and severity
Frequency: Continuously
Target: Reduction in seizures
Action Threshold: Lack of efficacy or worsening seizures
Adverse effects (CNS, psychiatric)
Frequency: Regularly, especially during dose titration and initial months
Target: Absence or tolerability of side effects
Action Threshold: Intolerable side effects (e.g., somnolence, dizziness, irritability, suicidal ideation)
Symptom Monitoring
- Dizziness
- Somnolence/fatigue
- Nausea/vomiting
- Irritability
- Anxiety
- Depression
- Aggression
- Suicidal thoughts or behavior
- Coordination problems
Special Patient Groups
Pregnancy
Brivaracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a pregnancy exposure registry for women taking antiepileptic drugs.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show developmental toxicity at clinically relevant exposures.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
Brivaracetam is excreted into human milk. The decision to discontinue breastfeeding or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the breastfed infant (e.g., sedation, poor feeding).
Infant Risk:
Moderate risk (L3) - monitor infant for sedation, irritability, poor feeding.
Pediatric Use
Approved for partial-onset seizures in patients 1 month of age and older. Dosing is weight-based for younger children and adolescents (4 to <16 years) for oral solution/injection. Tablets are approved for patients 16 years and older.
Geriatric Use
No specific dose adjustment is required based on age alone. However, dose adjustments may be necessary for elderly patients with renal or hepatic impairment, which are more common in this population.
Clinical Information
Clinical Pearls
- Brivaracetam is a newer generation AED with a high affinity for SV2A, similar to levetiracetam, but with potentially better tolerability (less behavioral side effects).
- It has a favorable pharmacokinetic profile with rapid and complete absorption, linear kinetics, and minimal protein binding, leading to fewer drug-drug interactions compared to older AEDs.
- Patients should be counseled on potential CNS side effects (dizziness, somnolence) and psychiatric symptoms (irritability, anxiety, suicidal ideation), especially during initial titration.
- Abrupt discontinuation should be avoided to prevent increased seizure frequency or status epilepticus.
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Lamotrigine (Lamictal)
- Valproate (Depakote)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
Cost & Coverage
Average Cost:
Varies, typically high 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 and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever your prescription is refilled. 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.