Briviact 10mg Tablets
It is used to treat seizures.
Drug Class
Antiepileptic
Pharmacologic Class
Synaptic Vesicle Glycoprotein 2A (SV2A) Ligand
Pregnancy Category
Not available
FDA Approved
Feb 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Briviact is a medication used to help control 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 cause 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 feeling well. 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 feeling well. 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
- Take Briviact exactly as prescribed by your doctor, usually twice a day, with or without food.
- Do not stop taking Briviact suddenly, as this can increase your risk of seizures. Always talk to your doctor before making any changes to your dose.
- Avoid alcohol while taking Briviact, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how Briviact affects you, as it can cause dizziness and drowsiness.
- 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: 50 mg twice daily (100 mg/day). Maintenance: 50 mg to 100 mg twice daily (100 mg to 200 mg/day).
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
adjunctiveTherapy:
Initial: 50 mg twice daily (100 mg/day). May adjust based on individual response and tolerability, up to 100 mg twice daily (200 mg/day).
monotherapy:
Not specifically approved for monotherapy in the US, but used off-label. Dosing typically follows adjunctive guidelines.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 years to <16 years: Initial: 0.5 mg/kg twice daily (1 mg/kg/day). Maintenance: 0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg/day to 4 mg/kg/day), not exceeding 100 mg twice daily (200 mg/day).
Adolescent:
16 years and older: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25 mg to 50 mg twice daily (50 mg to 100 mg/day).
Dialysis:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25 mg to 50 mg twice daily (50 mg to 100 mg/day). A supplemental dose is not needed after hemodialysis.
Hepatic Impairment:
Mild:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25 mg to 50 mg twice daily (50 mg to 100 mg/day).
Moderate:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25 mg to 50 mg twice daily (50 mg to 100 mg/day).
Severe:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25 mg to 50 mg twice daily (50 mg to 100 mg/day).
Pharmacology
Mechanism of Action
Brivaracetam exhibits a high and selective affinity for synaptic vesicle glycoprotein 2A (SV2A) in the brain. The precise mechanism by which brivaracetam exerts its antiepileptic effects is not fully understood, but binding to SV2A is thought to modulate neurotransmitter release, which may contribute to its anticonvulsant activity. It is structurally related to levetiracetam, another SV2A ligand, but has a higher affinity for SV2A.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 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:
Less than 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 9 hours
Clearance:
Not available
ExcretionRoute:
Renal (65% of dose), Fecal (28% of dose)
Unchanged:
Approximately 34% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 2-3 days of reaching target dose
DurationOfAction:
Approximately 12 hours (consistent with twice-daily dosing)
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
Inability to control eye movements
Suicidal thoughts or actions (especially in people with a history of suicidal thoughts or actions)
If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Mood or behavior changes
contact your doctor right away.
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, or if they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
* Nausea or vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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 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
Inability to control eye movements
Suicidal thoughts or actions (especially in people with a history of suicidal thoughts or actions)
If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Mood or behavior changes
contact your doctor right away.
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, or if they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
* Nausea or vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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:
- Severe dizziness or drowsiness
- Unusual changes in mood or behavior (e.g., agitation, aggression, depression, anxiety)
- Thoughts of harming yourself
- New or worsening seizures
- Allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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 safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about your health problems, as this may affect the safety of taking this medication.
* Always check with your doctor before starting, stopping, or changing the dose of any medication to avoid potential interactions or complications.
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 safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about your health problems, as this may affect the safety of taking this medication.
* Always check with your doctor before starting, stopping, or changing the dose of any medication to avoid potential interactions or complications.
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 instruct you 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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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 instruct you 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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Somnolence
- Dizziness
- Nausea
- Ataxia
- Diplopia
What to Do:
There is no specific antidote for brivaracetam overdose. Treatment should be symptomatic and supportive. Hemodialysis can remove brivaracetam. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
- Carbamazepine (may increase carbamazepine epoxide levels)
- Phenytoin (may decrease brivaracetam levels at high phenytoin doses)
Moderate Interactions
- Rifampin (may decrease brivaracetam levels)
- Phenobarbital (may decrease brivaracetam levels)
- Topiramate (additive CNS depression)
Minor Interactions
- Oral contraceptives (brivaracetam does not significantly affect hormonal contraceptive efficacy)
Monitoring
Baseline Monitoring
Renal function (SCr, eGFR)
Rationale: To determine appropriate dosing adjustments for patients with severe renal impairment.
Timing: Prior to initiation.
Hepatic function (ALT, AST, bilirubin)
Rationale: To determine appropriate dosing adjustments for patients with hepatic impairment.
Timing: Prior to initiation.
Psychiatric history (mood, behavior)
Rationale: To assess baseline for potential behavioral changes or suicidal ideation/behavior.
Timing: Prior to initiation.
Routine Monitoring
Clinical response (seizure frequency/severity)
Frequency: Regularly, especially during titration and dose changes.
Target: Individualized, aiming for optimal seizure control with minimal side effects.
Action Threshold: Lack of efficacy or intolerable side effects warrant dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, fatigue, behavioral changes)
Frequency: Regularly, especially during titration and dose changes.
Target: Absence or mild, tolerable side effects.
Action Threshold: Significant or intolerable side effects warrant dose reduction or discontinuation.
Mood and behavior (for suicidal ideation/behavior)
Frequency: Ongoing, especially during initial weeks of therapy and with dose changes.
Target: Stable mood and behavior.
Action Threshold: New or worsening depression, suicidal thoughts, or unusual changes in mood/behavior require immediate evaluation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Fatigue
- Nausea
- Vomiting
- Irritability
- Aggression
- Anxiety
- Depression
- Suicidal thoughts or behavior
- Coordination problems
Special Patient Groups
Pregnancy
Brivaracetam is not assigned a specific FDA pregnancy category. Animal studies have shown developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at doses higher than human therapeutic doses. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Enrollment in the North American Antiepileptic Drug (NAAED) Pregnancy Registry is encouraged.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though human data are limited.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks observed in animal studies.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks observed in animal studies.
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.
Infant Risk:
L3 (Moderately Safe - limited data, potential for mild adverse effects like sedation or irritability in infant, monitor infant for drowsiness or poor feeding).
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for children 4 to <16 years. Safety and efficacy in patients younger than 4 years have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may have age-related decreases in renal or hepatic function, which may necessitate dose adjustments as per renal/hepatic impairment guidelines. Monitor for increased susceptibility to CNS side effects (e.g., dizziness, somnolence).
Clinical Information
Clinical Pearls
- Brivaracetam has a high affinity for SV2A, similar to levetiracetam, but may offer an alternative for patients who do not tolerate levetiracetam due to behavioral side effects, though brivaracetam can also cause behavioral changes.
- Rapid titration is possible due to its favorable pharmacokinetic profile and good tolerability.
- Patients should be monitored for psychiatric symptoms, including suicidal ideation and behavior, as with all AEDs.
- No routine therapeutic drug monitoring is typically required for brivaracetam.
- Can be administered intravenously when oral administration is temporarily not feasible, with equivalent dosing.
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Perampanel (Fycompa)
- Cenobamate (Xcopri)
- Other antiepileptic drugs for partial-onset seizures (e.g., carbamazepine, oxcarbazepine, lamotrigine, topiramate, zonisamide)
Cost & Coverage
Average Cost:
Varies, typically $300-$600+ per 60 tablets (50mg)
Insurance Coverage:
Tier 3 or 4 (Non-preferred brand or Specialty)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.