Briviact 10mg/ml Solution
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 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 use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food.
When taking the liquid form of this medication, measure your dose accurately using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one. Do not use a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider and flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. After opening, discard any unused medication after 5 months. Do not freeze your medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food.
When taking the liquid form of this medication, measure your dose accurately using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one. Do not use a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider and flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. After opening, discard any unused medication after 5 months. Do not freeze your medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 a missed dose.
Lifestyle & Tips
- Do not stop taking Briviact suddenly without talking to your doctor, as this can cause seizures to worsen.
- Briviact may cause dizziness, drowsiness, and problems with coordination. Avoid driving or operating machinery until you know how this medicine affects you.
- Avoid alcohol while taking Briviact, as it can increase side effects like 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:
50 mg twice daily (BID) initially, may be adjusted based on individual patient response and tolerability.
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
adjunctive_therapy_partial_onset_seizures:
Initial: 50 mg BID. Maintenance: 50 mg to 100 mg BID. Max: 200 mg BID.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 1 month of age. For 1 month to less than 4 years: Initial 1 mg/kg BID, target 1-2.5 mg/kg BID, max 5 mg/kg BID.
Child:
4 years to less than 16 years: Initial 0.5 mg/kg BID, target 0.5-2 mg/kg BID, max 4 mg/kg BID (for patients weighing 20-50 kg). For patients weighing âĨ50 kg, adult dosing applies.
Adolescent:
16 years and older: Adult dosing applies (initial 50 mg BID, target 50-100 mg BID, max 200 mg BID).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
For patients with severe renal impairment (CrCl < 30 mL/min) not on dialysis, a starting dose of 25 mg BID is recommended, with a maximum recommended dose of 75 mg BID.
Dialysis:
For patients on hemodialysis, a starting dose of 25 mg BID is recommended, with a maximum recommended dose of 75 mg BID. A supplemental dose is not needed after dialysis.
Hepatic Impairment:
Mild:
For patients with mild to moderate hepatic impairment, a starting dose of 25 mg BID is recommended, with a maximum recommended dose of 75 mg BID.
Moderate:
For patients with mild to moderate hepatic impairment, a starting dose of 25 mg BID is recommended, with a maximum recommended dose of 75 mg BID.
Severe:
For patients with severe hepatic impairment, a starting dose of 25 mg BID is recommended, with a maximum recommended dose of 75 mg BID.
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.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
0.5 to 2 hours
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
ExcretionRoute:
Renal (65% as metabolites, 35% as unchanged drug)
Unchanged:
Approximately 35%
Pharmacodynamics
OnsetOfAction:
Rapid
PeakEffect:
Within 2 hours
DurationOfAction:
Not directly specified, but consistent 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
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. If you experience any of the following side effects, or if they bother you or persist, contact your doctor or seek medical help:
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, 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 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)
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, or if they bother you or persist, contact your doctor or seek medical help:
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, 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 or anxiety
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worsening irritability
- Aggression, anger, or violence
- Panic attacks
- Extreme worry
- Other unusual changes in behavior or mood
- Severe dizziness or loss of coordination
- Rash or hives (signs of allergic reaction)
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 with all 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 with all your other medications and health conditions.
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. Additionally, 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, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as they relate to both you and your baby.
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. Additionally, 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, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as they relate to both you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Somnolence
- Nausea
- Ataxia (loss of coordination)
- Blurred vision
What to Do:
Call 911 or Poison Control at 1-800-222-1222 immediately. Seek emergency medical attention. There is no specific antidote for brivaracetam overdose. Treatment is supportive and may include gastric lavage or activated charcoal if ingestion was recent.
Drug Interactions
Moderate Interactions
- Carbamazepine (may increase carbamazepine epoxide levels)
- Phenytoin (may increase phenytoin levels, especially at higher brivaracetam doses)
- Oral contraceptives (brivaracetam may decrease ethinyl estradiol and levonorgestrel levels, though generally not clinically significant)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate dosing in patients with renal impairment.
Timing: Prior to initiation of therapy.
Hepatic function (LFTs)
Rationale: To determine appropriate dosing in patients with hepatic impairment.
Timing: Prior to initiation of therapy.
Psychiatric history
Rationale: To assess baseline risk for mood changes, depression, or suicidal ideation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency, improved seizure control.
Action Threshold: Increased seizure frequency or lack of efficacy may warrant dose adjustment or alternative therapy.
Adverse effects (CNS, psychiatric)
Frequency: Regularly, especially during dose titration and initial months of therapy.
Target: Absence or minimal severity of dizziness, somnolence, fatigue, irritability, mood changes, suicidal ideation.
Action Threshold: Significant or worsening adverse effects may require dose reduction or discontinuation.
Drug interactions (if co-administered with phenytoin or carbamazepine)
Frequency: Consider monitoring plasma levels of co-administered drugs if clinically indicated.
Target: Therapeutic range for co-administered drugs.
Action Threshold: Levels outside therapeutic range may require dose adjustment of brivaracetam or co-administered drug.
Symptom Monitoring
- Dizziness
- Somnolence
- Fatigue
- Nausea
- Vomiting
- Irritability
- Anxiety
- Depression
- Aggression
- Suicidal thoughts or behavior
- Coordination problems
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Data from animal studies show developmental toxicity (embryo-fetal mortality, reduced fetal weight, skeletal variations) at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, consistent with other AEDs. Discuss risks and benefits with healthcare provider.
Second Trimester:
Not specifically studied, but continued monitoring of maternal and fetal health is recommended.
Third Trimester:
Not specifically studied, but continued monitoring of maternal and fetal health is recommended. Consider potential for withdrawal symptoms in neonate if exposure is close to delivery.
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:
Potential for somnolence, irritability, and poor feeding in breastfed infants. Monitor infants for these effects.
Pediatric Use
Approved for patients 1 month of age and older. Dosing is weight-based for younger children. Safety and efficacy in neonates (under 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. Elderly patients may be more susceptible to CNS adverse effects (e.g., dizziness, somnolence).
Clinical Information
Clinical Pearls
- Brivaracetam is generally well-tolerated with a favorable pharmacokinetic profile (linear kinetics, low protein binding, minimal CYP interactions).
- It can be initiated at a therapeutic dose without titration in some patients, but gradual titration is often preferred to minimize CNS side effects.
- Patients should be monitored for psychiatric symptoms, including suicidal ideation, as with all AEDs.
- The oral solution is useful for patients who have difficulty swallowing tablets or require precise dose adjustments.
- Consider dose reduction in patients with severe renal or any degree of hepatic impairment.
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Perampanel (Fycompa)
- Cenobamate (Xcopri)
- Other antiepileptic drugs for partial-onset seizures (e.g., carbamazepine, oxcarbazepine, lamotrigine, topiramate, phenytoin)
Cost & Coverage
Average Cost:
Varies widely, typically high for brand-name AEDs per 300 ml (10mg/ml) bottle
Insurance Coverage:
Tier 3 or 4 (Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. Please read this guide 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. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.