Brivasure
Brivasure Uses, Dosage, Side Effects, Food Interaction and all others data.
The precise mechanism by which Brivasure exerts its anticonvulsant activity is not known. Brivasure displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.Brivasure binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivasure is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action
Brivasure binds SV2A with high affinity . SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release . It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivasure is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action .
Trade Name | Brivasure |
Availability | Prescription only |
Generic | Brivaracetam |
Brivaracetam Other Names | Brivaracetam |
Related Drugs | gabapentin, clonazepam, lamotrigine, diazepam, pregabalin, Lyrica, topiramate, levetiracetam, Keppra, Topamax |
Type | Tablet |
Formula | C11H20N2O2 |
Weight | Average: 212.2887 Monoisotopic: 212.152477894 |
Protein binding | Label. |
Groups | Approved, Investigational |
Therapeutic Class | Adjunct anti-epileptic drugs |
Manufacturer | Alkem Laboratories Ltd |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Brivasure is used for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Brivasure injection in pediatric patients has not been established, Brivasure injection is used for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.
Renal Impairment: Dose adjustments are not required for patients with impaired renal function.
Brivasure is also used to associated treatment for these conditions: Partial-Onset Seizures
How Brivasure works
The precise mechanism of brivaracetam's anti-epileptogenic activity is unknown.
Dosage
Brivasure dosage
Adults (16 Years and older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day).
Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily
Injection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.
Brivasure injection should be administered intravenously over 2 to 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. Brivasure injection is for single dose only.
Side Effects
Most common adverse reactions (at least 5% for Brivasure and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea or vomiting.
Toxicity
No carcinogenesis or fertility impairment found. Overdose is associated with somnolence and dizziness .
Precaution
Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.
Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivasure.
Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.
Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Brivasure if hypersensitivity occurs.
Withdrawal of Antiepileptic Drugs: Brivasure should be gradually withdrawn.
Interaction
Rifampin: Because of decreased concentrations, increasing Brivasure dosage in patients on concomitant rifampin is recommended.
Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Brivasure.
Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivasure.
Levetiracetam: Brivasure had no added therapeutic benefit when co-administered with levetiracetam.
Food Interaction
- Avoid alcohol. Taking Brivasure with alcohol may increase alcohol's effects on attention, memory, and psychomotor functioning.
- Take with or without food.
Brivasure Alcohol interaction
[Moderate] GENERALLY AVOID:
Alcohol may potentiate some of the pharmacologic effects of central nervous system (CNS)-active agents.
Use in combination may result in additive CNS depression and/or impairment of judgment, thinking, and psychomotor skills.
Patients receiving CNS-active agents should be advised to avoid or limit consumption of alcohol.
Ambulatory patients should be counseled against driving, operating machinery, or engaging in potentially hazardous activities requiring mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.
Brivasure Drug Interaction
Moderate: divalproex sodium, diazepam, perampanel, levetiracetam, lithium, clobazam, topiramate, valproic acidUnknown: arginine, levocarnitine, cysteine, polyethylene glycol 3350, mometasone nasal, lacosamide, thiamine, cyanocobalamin, pyridoxine, cholecalciferol, phytonadione, menaquinone
Brivasure Disease Interaction
Moderate: suicidal tendency, bronchospasm/angioedema., hepatic dysfunction, renal impairment
Volume of Distribution
0.5L/kg .
Elimination Route
Nearly 100% oral bioavailability .
Half Life
7-8h .
Clearance
CL/F of 0.7-1.07 mL/min kg . Clearance is primarily metabolic with less than 10% of the parent drug excreted unchanged.
Elimination Route
>95% excreted in urine with Label.
Pregnancy & Breastfeeding use
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Brivasure, during pregnancy. No data are available regarding the presence of brivaracetam in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Studies in lactating rats have shown excretion of brivaracetam or metabolites in milk
Contraindication
Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivasure
Storage Condition
Store at 25°C; excursions permitted between 15°C to 30°C
Innovators Monograph
You find simplified version here Brivasure
Brivasure contains Brivaracetam see full prescribing information from innovator Brivasure Monograph, Brivasure MSDS, Brivasure FDA label