Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Brivaracetam injection in pediatric patients has not been established, Brivaracetam injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

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.

Administration

Brivaracetam 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. Brivaracetam injection is for single dose only.

Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam

Most common adverse reactions (at least 5% for Brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea or vomiting.

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 Brivaracetam.

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 Brivaracetam if hypersensitivity occurs. 

Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn.

Use in Special Populations

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.

Pregnancy & Lactation

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Brivaracetam, 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