Bivara Tablet 50 mg

Uses

Bivara Tablet 50 mg is used for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Bivara Tablet 50 mg injection in pediatric patients has not been established, Bivara Tablet 50 mg 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.

Bivara Tablet 50 mg is also used to associated treatment for these conditions: Partial-Onset Seizures

How Bivara Tablet 50 mg works

The precise mechanism of brivaracetam's anti-epileptogenic activity is unknown.

Dosage

Bivara Tablet 50 mg 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.

Bivara Tablet 50 mg 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. Bivara Tablet 50 mg injection is for single dose only.

Side Effects

Most common adverse reactions (at least 5% for Bivara Tablet 50 mg 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 Bivara Tablet 50 mg.

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 Bivara Tablet 50 mg if hypersensitivity occurs. 

Withdrawal of Antiepileptic Drugs: Bivara Tablet 50 mg should be gradually withdrawn.

Interaction

Rifampin: Because of decreased concentrations, increasing Bivara Tablet 50 mg 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 Bivara Tablet 50 mg.

Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Bivara Tablet 50 mg.

Levetiracetam: Bivara Tablet 50 mg had no added therapeutic benefit when co-administered with levetiracetam.

Food Interaction

• Avoid alcohol. Taking Bivara Tablet 50 mg with alcohol may increase alcohol's effects on attention, memory, and psychomotor functioning.
• Take with or without food.

Bivara Tablet 50 mg 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.

Bivara Tablet 50 mg 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

Bivara Tablet 50 mg 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 Bivara Tablet 50 mg, 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 Bivara Tablet 50 mg

Storage Condition

Store at 25°C; excursions permitted between 15°C to 30°C

Innovators Monograph

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