Briviact 100mg 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
Feb 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Briviact is a medicine used to treat partial-onset seizures (seizures that start in one part of the brain) in people 1 month of age and older. It works by affecting certain proteins in the brain to help calm overactive nerve signals that can cause seizures.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the medication 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 way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
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, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep the medication 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 way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
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. Do not stop taking it suddenly, as this can cause seizures to worsen.
- Do not drive or operate heavy machinery until you know how Briviact affects you, as it can cause dizziness and drowsiness.
- Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements.
- If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits with your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 50 mg twice daily (100 mg/day). Maintenance: 50-100 mg twice daily (100-200 mg/day).
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
initial:
Start with 50 mg twice daily (100 mg/day).
maintenance:
Adjust based on individual patient response and tolerability, up to 100 mg twice daily (200 mg/day). Doses up to 200 mg twice daily (400 mg/day) have been studied but offer no additional benefit and increase adverse reactions.
rapid_initiation:
Can be initiated with a single intravenous (IV) loading dose of 100 mg, followed by oral or IV maintenance dosing.
Pediatric Dosing
Neonatal:
Not established (limited data for <1 month).
Infant:
1 month to <4 years: Initial 0.75 mg/kg twice daily (1.5 mg/kg/day). Maintenance 0.75-2.5 mg/kg twice daily (1.5-5 mg/kg/day). Max 5 mg/kg twice daily (10 mg/kg/day).
Child:
4 years to <16 years: Initial 0.75 mg/kg twice daily (1.5 mg/kg/day). Maintenance 0.75-2.5 mg/kg twice daily (1.5-5 mg/kg/day). Max 5 mg/kg twice daily (10 mg/kg/day). For patients weighing ≥50 kg, adult dosing applies.
Adolescent:
16 years and older: Adult dosing applies (Initial 50 mg twice daily, Maintenance 50-100 mg twice daily).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No dose adjustment needed. Brivaracetam is removed by hemodialysis (50% removed in 4 hours). Administer the daily dose in two divided doses, with the second dose given after the dialysis session.
Hepatic Impairment:
Mild:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25-75 mg twice daily (50-150 mg/day).
Moderate:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25-75 mg twice daily (50-150 mg/day).
Severe:
Initial: 25 mg twice daily (50 mg/day). Maintenance: 25-75 mg twice daily (50-150 mg/day).
Pharmacology
Mechanism of Action
Brivaracetam is a selective, high-affinity ligand for synaptic vesicle glycoprotein 2A (SV2A) in the brain. While the precise mechanism by which brivaracetam exerts its antiepileptic effect is not fully understood, binding to SV2A is thought to modulate neurotransmitter release, thereby stabilizing hyperexcitable neuronal membranes and reducing seizure activity. It has a 10-fold higher affinity for SV2A than levetiracetam.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 2 hours (oral)
FoodEffect:
Food does not affect the extent of absorption, but it 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 (total body clearance ~3.4 L/h)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 65% of the dose is excreted in urine as metabolites, and 34% as unchanged drug.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 1-2 hours of administration
DurationOfAction:
Consistent with twice-daily dosing (due to half-life)
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)
Like other seizure medications, this drug may increase the risk of suicidal thoughts or behaviors. If you experience any new or worsening symptoms such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Mood or behavior changes
call your doctor right away. If you have suicidal thoughts or actions, seek medical attention immediately.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects and they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
* Nausea or vomiting
This is not a comprehensive list of all 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)
Like other seizure medications, this drug may increase the risk of suicidal thoughts or behaviors. If you experience any new or worsening symptoms such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Mood or behavior changes
call your doctor right away. If you have suicidal thoughts or actions, seek medical attention immediately.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects and they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
* Nausea or vomiting
This is not a comprehensive list of all 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 of self-harm or suicide
- Aggression, agitation, or unusual changes in mood or behavior
- Severe rash or skin reactions (e.g., Stevens-Johnson syndrome)
- Swelling of the face, lips, tongue, or throat (angioedema), difficulty breathing or swallowing
- Unexplained fever, sore throat, or easy bruising/bleeding (signs of blood problems)
- Severe dizziness or extreme drowsiness
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 various substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.
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 various substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Until you are aware of how this medication affects you, it is recommended that you avoid operating a vehicle and engaging in other activities that require alertness.
Do not abruptly discontinue use of this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If it is necessary 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, it is crucial to discuss them with your doctor.
If you have a history of seizures and notice a change in their frequency or severity after starting this medication, you should promptly consult with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as this will enable you to make an informed decision regarding your treatment and the well-being of your baby.
Until you are aware of how this medication affects you, it is recommended that you avoid operating a vehicle and engaging in other activities that require alertness.
Do not abruptly discontinue use of this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If it is necessary 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, it is crucial to discuss them with your doctor.
If you have a history of seizures and notice a change in their frequency or severity after starting this medication, you should promptly consult with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as this will enable you to make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Somnolence
- Nausea
- Ataxia (loss of coordination)
- Diplopia (double vision)
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 decrease brivaracetam plasma concentrations, consider dose increase of brivaracetam)
- Phenytoin (may increase phenytoin plasma concentrations, monitor phenytoin levels)
- Phenobarbital (may decrease brivaracetam plasma concentrations, consider dose increase of brivaracetam)
- Rifampin (strong CYP enzyme inducer, may decrease brivaracetam levels, consider dose increase of brivaracetam)
Moderate Interactions
- Oral contraceptives (brivaracetam may decrease ethinyl estradiol and levonorgestrel concentrations, consider higher dose oral contraceptives or alternative contraception)
- Alcohol (additive CNS depressant effects)
Monitoring
Baseline Monitoring
Renal function (SCr, eGFR)
Rationale: To guide dosing in patients with severe renal impairment on dialysis.
Timing: Prior to initiation.
Hepatic function (ALT, AST, bilirubin)
Rationale: To guide dosing in patients with hepatic impairment.
Timing: Prior to initiation.
Complete Blood Count (CBC)
Rationale: Although rare, AEDs can cause hematologic abnormalities.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency, improved seizure control.
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, fatigue, irritability, mood changes)
Frequency: Regularly, at each follow-up visit, especially during dose titration.
Target: Minimization of side effects.
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Mental health and behavioral changes (e.g., suicidal ideation, depression, aggression)
Frequency: Regularly, at each follow-up visit.
Target: Stable mood and behavior.
Action Threshold: New or worsening psychiatric symptoms require immediate evaluation and intervention.
Symptom Monitoring
- Dizziness
- Somnolence/Sedation
- Fatigue
- Nausea/Vomiting
- Irritability
- Anxiety
- Depression
- Aggression
- Suicidal thoughts or behavior
- Coordination problems
- Changes in seizure pattern
- Signs of hypersensitivity reactions (rash, swelling, difficulty breathing)
Special Patient Groups
Pregnancy
Brivaracetam is in Pregnancy Category C (older system) or falls under the new Pregnancy and Lactation Labeling Rule (PLLR). 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. A pregnancy registry is available.
Trimester-Specific Risks:
First Trimester:
Animal studies show developmental toxicity (embryo-fetal mortality, reduced fetal weight, skeletal variations) at doses higher than human therapeutic exposure. Human data are limited.
Second Trimester:
Limited human data, animal data suggest potential risks.
Third Trimester:
Limited human data, animal data suggest potential risks.
Lactation
Brivaracetam is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Briviact, and any potential adverse effects on the breastfed infant from Briviact or from the underlying maternal condition. Monitor breastfed infants for sedation, irritability, or poor feeding.
Infant Risk:
L3 (Moderately Safe - There are no controlled studies in breastfeeding women, but the risk of adverse effects to the infant is possible. Use should be weighed against the benefits of breastfeeding.)
Pediatric Use
Approved for partial-onset seizures in patients 1 month of age and older. Dosing is weight-based for younger children. Safety and efficacy in neonates (<1 month) have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the adverse effects (e.g., dizziness, somnolence) and may have age-related renal or hepatic impairment requiring dose adjustment.
Clinical Information
Clinical Pearls
- Brivaracetam is a newer generation AED with a high affinity for SV2A, similar to levetiracetam but with potentially fewer behavioral side effects in some patients.
- It has a rapid onset of action and can be initiated at a therapeutic dose without titration in many cases, though a slower titration is also an option.
- Available in oral tablets, oral solution, and intravenous (IV) formulation, allowing for seamless transition between formulations.
- Minimal drug-drug interactions compared to older AEDs, but monitor for interactions with enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampin) and oral contraceptives.
- Counsel patients on potential CNS side effects (dizziness, somnolence, fatigue) and psychiatric/behavioral changes (irritability, aggression, suicidal ideation).
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Oxcarbazepine (Trileptal)
- Carbamazepine (Tegretol)
- Phenytoin (Dilantin)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
Cost & Coverage
Average Cost:
$300 - $1000+ per 30 tablets (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug)
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.