Briviact 75mg 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 seizures in people with epilepsy. It works by affecting certain proteins in the brain that are involved in nerve cell communication, which helps to calm overactive brain signals that can 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 to feel better. It's crucial to complete the full course of treatment as prescribed.
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 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, 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 complete the full course of treatment as prescribed.
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 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 or occur more frequently.
- 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 suicidal thoughts to your doctor immediately.
- Carry a medical alert card or wear a medical alert bracelet indicating you have epilepsy and are taking antiepileptic medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg twice daily (BID) initially, titrate to 50-200 mg BID
Dose Range:
100 - 400 mg
Condition-Specific Dosing:
initial:
50 mg BID
maintenance:
50-200 mg BID
maximum:
200 mg BID (400 mg/day)
Pediatric Dosing
Neonatal:
Not established (approved for 1 month and older)
Infant:
1 month to <4 years: 2.5 mg/kg BID initially, target 2.5-7.5 mg/kg BID (max 7.5 mg/kg BID)
Child:
4 years to <16 years: 1 mg/kg BID initially, target 1-3 mg/kg BID (max 3 mg/kg BID)
Adolescent:
16 years and older: Same as adult dosing (50 mg BID initially, target 50-200 mg BID)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Maximum 75 mg BID (150 mg/day)
Dialysis:
Maximum 75 mg BID (150 mg/day); administer after dialysis on dialysis days
Hepatic Impairment:
Mild:
Maximum 75 mg BID (150 mg/day)
Moderate:
Maximum 75 mg BID (150 mg/day)
Severe:
Maximum 50 mg BID (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, binding to SV2A is thought to modulate neurotransmitter release, thereby stabilizing hyperexcitable neuronal membranes and reducing seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
0.5-2 hours
FoodEffect:
No clinically significant effect on absorption or pharmacokinetics
Distribution:
Vd:
0.5 L/kg
ProteinBinding:
<20%
CnssPenetration:
Yes
Elimination:
HalfLife:
9 hours
Clearance:
Not available
ExcretionRoute:
Renal (95% as metabolites, 5% unchanged drug)
Unchanged:
5%
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 2 hours of dose
DurationOfAction:
Approximately 12 hours (consistent with BID 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 medical attention immediately:
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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
Vomiting
These are not all the possible side effects of this medication. 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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach
Vomiting
These are not all the possible side effects of this medication. 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:
- Unusual changes in mood or behavior (e.g., aggression, agitation, depression, anxiety)
- Thoughts of harming yourself or others
- Severe dizziness or drowsiness that interferes with daily activities
- Difficulty with coordination or balance
- New or worsening seizures
- Allergic reactions (e.g., 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 as a result of the allergy.
If you are undergoing dialysis, discuss this with your doctor, as it may affect your treatment.
This medication can interact with various other drugs and 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 (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or adjust the dose of any medication without first consulting 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 as a result of the allergy.
If you are undergoing dialysis, discuss this with your doctor, as it may affect your treatment.
This medication can interact with various other drugs and 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 (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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:
- Dizziness
- Somnolence
- Nausea
- Ataxia (loss of coordination)
- Diplopia (double vision)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive, including gastric lavage if recent ingestion, and close monitoring of vital signs.
Drug Interactions
Moderate Interactions
- Carbamazepine (may decrease carbamazepine epoxide levels, clinical significance uncertain)
- Phenytoin (may increase phenytoin levels at higher brivaracetam doses, monitor phenytoin levels)
- Phenobarbital (may increase phenobarbital levels at higher brivaracetam doses, monitor phenobarbital levels)
- Rifampin (may decrease brivaracetam exposure, consider dose adjustment)
- Alcohol (increased CNS depression)
Monitoring
Baseline Monitoring
Renal function (SCr, eGFR)
Rationale: To guide initial dosing and adjustments in patients with renal impairment.
Timing: Prior to initiation
Hepatic function (ALT, AST, bilirubin)
Rationale: To guide initial dosing and adjustments in patients with hepatic impairment.
Timing: Prior to initiation
Psychiatric history (depression, suicidal ideation)
Rationale: AEDs carry a risk of suicidal thoughts/behavior; assess baseline risk.
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, worsening seizures (consider dose adjustment or alternative therapy)
Adverse effects (CNS depression, behavioral changes, mood changes)
Frequency: Regularly, at each follow-up visit
Target: Absence or tolerability of side effects
Action Threshold: Intolerable side effects (consider dose reduction or discontinuation)
Mental status and mood
Frequency: Regularly, at each follow-up visit
Target: Stable mood, absence of suicidal ideation
Action Threshold: New or worsening depression, suicidal thoughts/behavior (immediate evaluation and intervention)
Symptom Monitoring
- Dizziness
- Somnolence
- Fatigue
- Nausea
- Vomiting
- Irritability
- Aggression
- Anxiety
- Depression
- 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. Advise pregnant women to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Trimester-Specific Risks:
First Trimester:
Limited human data, but animal studies show developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at clinically relevant exposures.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks. Consider potential for withdrawal symptoms in neonate if discontinued abruptly.
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. Monitor breastfed infants for sedation, irritability, and poor feeding.
Infant Risk:
Low to moderate risk. Monitor for drowsiness, poor feeding, or developmental milestones.
Pediatric Use
Approved for use in patients 1 month of age and older. Dosing is weight-based for younger children. Safety and efficacy in neonates younger than 1 month have not been established.
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 high affinity for SV2A, similar to levetiracetam but with potentially fewer behavioral side effects in some patients.
- It can be rapidly titrated to target doses, often within days, which is an advantage for quick seizure control.
- Unlike some other AEDs, brivaracetam has minimal drug-drug interactions via CYP450 enzymes, making it a good option for polytherapy.
- Patients should be counselled on the risk of psychiatric adverse events, including suicidal ideation, and encouraged to report any changes in mood or behavior.
- Oral solution and IV formulations are available, allowing for flexibility in administration, including for patients who cannot take oral medication temporarily.
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Perampanel (Fycompa)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Valproic Acid (Depakote)
Cost & Coverage
Average Cost:
Not available 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.