Briviact 50mg/5ml Inj, 5ml
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
Jan 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Briviact is a medicine used to treat seizures (epilepsy). It works by affecting certain proteins in the brain that are involved in seizure activity. The injection form is used when you cannot take the medicine by mouth, for example, in a hospital setting.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. This medication is administered intravenously over a specified period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. This medication is administered intravenously over a specified period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
Lifestyle & Tips
- Do not drive or operate heavy machinery until you know how Briviact affects you, as it can cause dizziness and sleepiness.
- Avoid alcohol while taking Briviact, as it can increase side effects like dizziness and drowsiness.
- Do not stop taking Briviact suddenly without talking to your doctor, as this can cause seizures to worsen or occur more frequently.
- Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 50 mg twice daily (BID) or 100 mg BID. Maintenance: 50 mg to 200 mg BID. Loading dose: 100 mg (single dose).
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
loadingDose:
100 mg single intravenous dose, administered over 2 to 15 minutes.
maintenanceDose:
Administer 50 mg to 200 mg BID, administered over 2 to 15 minutes.
Pediatric Dosing
Neonatal:
Not established (approved for 1 month and older)
Infant:
1 month to < 4 years: Initial 1.25 mg/kg BID, Maintenance 1.25 mg/kg to 2.5 mg/kg BID. Max 75 mg BID.
Child:
4 years to < 16 years: Initial 1 mg/kg BID, Maintenance 1 mg/kg to 2 mg/kg BID. Max 100 mg BID.
Adolescent:
16 years and older: Same as adult dosing (Initial 50 mg BID or 100 mg BID, Maintenance 50 mg to 200 mg BID).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Maximum recommended dose is 150 mg BID (CrCl < 30 mL/min).
Dialysis:
Maximum recommended dose is 150 mg BID. Administer after dialysis session on dialysis days.
Hepatic Impairment:
Mild:
Maximum recommended dose is 150 mg BID.
Moderate:
Maximum recommended dose is 150 mg BID.
Severe:
Maximum recommended dose is 100 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.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, peak concentration achieved rapidly)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.5 L/kg
ProteinBinding:
< 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 9 hours
Clearance:
Approximately 3.4 L/h
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 24%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes for IV administration)
PeakEffect:
Rapid (within minutes for IV administration)
DurationOfAction:
Consistent with half-life, allowing for twice-daily dosing.
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 if you have 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 report any concerns to 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
Vomiting
Reporting Side Effects
This is not an exhaustive list of 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 if you have 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 report any concerns to 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
Vomiting
Reporting Side Effects
This is not an exhaustive list of 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 about self-harm or suicide
- Unusual changes in mood or behavior (e.g., agitation, aggression, panic attacks)
- New or worsening rash, hives, or swelling (signs of allergic reaction)
- Difficulty breathing or swallowing
- Severe dizziness or extreme sleepiness
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, as it may affect your treatment.
This medication can interact with 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
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 best possible treatment outcome.
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, as it may affect your treatment.
This medication can interact with 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
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 best possible treatment outcome.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. This will help prevent accidents and ensure your safety.
Stopping the Medication
Do not suddenly stop taking this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize potential risks.
Mental Health and Behavioral Changes
This medication may cause changes in behavior, mental health, or mood. If you experience any of these changes, discuss them with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult your doctor to determine the best course of action.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Use in Children
This medication is not approved for use in children. However, your child's doctor may decide that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask their doctor about the potential benefits and risks, and discuss any questions or concerns you may have.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. This will help prevent accidents and ensure your safety.
Stopping the Medication
Do not suddenly stop taking this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize potential risks.
Mental Health and Behavioral Changes
This medication may cause changes in behavior, mental health, or mood. If you experience any of these changes, discuss them with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult your doctor to determine the best course of action.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Use in Children
This medication is not approved for use in children. However, your child's doctor may decide that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask their doctor about the potential benefits and risks, and discuss any questions or concerns you may have.
Overdose Information
Overdose Symptoms:
- Dizziness
- Somnolence (excessive sleepiness)
- Nausea
- Vertigo
- Ataxia (loss of coordination)
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). There is no specific antidote. Treatment should be symptomatic and supportive, including monitoring of vital signs and clinical status.
Drug Interactions
Major Interactions
- Rifampin (may decrease brivaracetam plasma concentrations)
- Phenytoin (may decrease brivaracetam plasma concentrations, and brivaracetam may increase phenytoin levels at higher doses)
Moderate Interactions
- Carbamazepine (may decrease brivaracetam plasma concentrations)
- Phenobarbital (may decrease brivaracetam plasma concentrations)
- Alcohol (may increase CNS depressant effects)
Monitoring
Baseline Monitoring
Seizure history and characteristics
Rationale: To establish baseline seizure frequency and type for efficacy assessment.
Timing: Prior to initiation of therapy.
Renal function (CrCl)
Rationale: To determine need for dose adjustment in patients with severe renal impairment or ESRD.
Timing: Prior to initiation of therapy, especially in patients with suspected renal dysfunction.
Hepatic function (LFTs)
Rationale: To determine need for dose adjustment in patients with hepatic impairment.
Timing: Prior to initiation of therapy, especially in patients with suspected hepatic dysfunction.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency.
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, irritability, mood changes)
Frequency: Regularly, at each follow-up visit.
Target: Minimization of side effects.
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Signs of suicidal ideation or behavior
Frequency: Regularly, especially during initial treatment and dose changes.
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any new or worsening suicidal thoughts/behaviors require immediate clinical evaluation and intervention.
Symptom Monitoring
- Changes in mood or behavior (e.g., aggression, agitation, depression, anxiety)
- Suicidal thoughts or attempts
- Signs of hypersensitivity reactions (e.g., rash, swelling, difficulty breathing)
- Dizziness or somnolence
- Nausea or vomiting
Special Patient Groups
Pregnancy
Brivaracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available to monitor outcomes in women exposed to AEDs during pregnancy.
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.
Infant Risk:
L3 (Moderately Safe) - Monitor breastfed infants for sedation, irritability, poor feeding, or developmental milestones.
Pediatric Use
Approved for patients 1 month of age and older. Dosing is weight-based and differs for various age groups. Safety and efficacy in neonates (<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. Start at the lower end of the dosing range and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Brivaracetam IV formulation offers rapid onset of action, making it suitable for situations where rapid seizure control is needed or when oral administration is not feasible (e.g., status epilepticus, perioperative period).
- It has a favorable pharmacokinetic profile with low protein binding and minimal CYP450 metabolism, leading to fewer drug-drug interactions compared to some older AEDs.
- Patients transitioning from IV to oral brivaracetam can do so directly at the same total daily dose and frequency.
- Monitor patients for neuropsychiatric adverse events, including mood changes and suicidal ideation, especially during initial treatment and dose adjustments.
Alternative Therapies
- Levetiracetam (Keppra)
- Lacosamide (Vimpat)
- Phenytoin (Dilantin)
- Valproic Acid (Depakote)
- Fosphenytoin (Cerebyx)
- Phenobarbital
Cost & Coverage
Average Cost:
Price varies, typically high per 5ml vial
Insurance Coverage:
Tier 3 / Specialty Drug (requires prior authorization)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which can be an alternative disposal option.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.