Usual Adult Dose for Epilepsy

Initial dose: 50 mg orally 2 times a day

• Based on individual patient tolerability and response, dose should be adjusted up or down

Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability
Maximum dose: 200 mg/day

IV Administration:

• May be used when oral administration is temporarily not feasible
• Administer at the same dose and same frequency as oral formulations
• Experience with IV injection is limited to 4 consecutive days of treatment

Comments:

• When initiating therapy, gradual dose escalation is not required; following initiation, dose should be adjusted based on clinical response and tolerability.
• Tablets, oral solution and injection can be used interchangeably.

Use: For the treatment of partial-onset seizures

Usual Pediatric Dose for Epilepsy

1 month to 16 years:

• Weight: Less than 11 kg: Initial dose: 0.75 to 1.5 mg/kg orally twice a day; Maintenance dose: 0.75 to 3 mg/kg orally twice a day
• Weight: 11 kg to less than 20 kg: Initial dose: 0.5 to 1.25 mg/kg orally twice a day; Maintenance dose: 0.5 to 2.5 mg/kg orally twice a day
• Weight: 20 kg to less than 50 kg: Initial dose: 0.5 to 1 mg/kg orally twice a day; Maintenance dose: 0.5 to 2 mg/kg orally twice a day
• Weight: 50 kg or greater: Initial dose: 25 to 50 mg orally twice a day; Maintenance dose: 25 to 100 mg orally twice a day

16 years of age and older:
Initial dose: 50 mg orally 2 times a day
Maintenance dose: 25 mg to 100 mg orally twice a day

IV Administration: May be used in patients 16 years or older when oral administration is temporarily not feasible

• Administer at the same dose and same frequency as oral formulations
• Experience with the IV injection is limited to 4 consecutive days of treatment

Comments:

• When initiating therapy, gradual dose escalation is not required; following initiation, dose should be adjusted based on clinical response and tolerability.
• Tablets, oral solution and injection can be used interchangeably.

Use: For the treatment of partial-onset seizures in patients 1 month or older

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended
ESRD undergoing dialysis: Not recommended

Liver Dose Adjustments

Adults and Pediatric Patients: Weight: 50 kg or greater:

• Initial dose: 25 mg twice a day
• Maximum dose: 75 mg twice a day

Pediatric Patients: Weight: 20 kg to less than 50 kg:

• Initial dose: 0.5 mg/kg twice a day
• Maximum dose: 1.5 mg/kg twice a day

Pediatric Patients: Weight: 11 kg to less than 20 kg:

• Initial dose: 0.5 mg/kg twice a day
• Maximum dose: 2 mg/kg twice a day

Pediatric Patients: Weight: Less than 11 kg:

• Initial dose: 0.75 mg/kg twice a day
• Maximum dose: 2.25 mg/kg twice a day

Dose Adjustments

Elderly: Dose selection should be judicious, generally starting at the low end of dosing range

Concomitant Administration with Rifampin:

• Dose of brivaracetam should be increased up to 100% (i.e., double the dose)

Discontinuation:

• Avoid abrupt withdrawal of therapy in order to minimize the risk of increased seizure frequency and status epilepticus.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 1 month.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V

Dialysis

Not recommended

Other Comments

Administration Advice:
Oral Tablets and Oral Solution:

• Take orally twice a day with or without food
• Oral tablets: Swallow whole with liquid; do not chew or crush
• Oral solution: A calibrated measuring device should be used to measure and deliver prescribed dose accurately; a household teaspoon or tablespoon is not an adequate measuring device
• Oral solution may be administered using a nasogastric tube or gastrostomy tube

IV Administration:

• May be used when oral administration is temporarily not feasible
• Administer IV over 2 to 15 minutes

Storage Requirements:

• Store at controlled room temperature
• Injection and oral solution: Do not freeze
• Oral Solution: Discard unused oral solution 5 months after date of first opening

IV Preparation Techniques:

• May be administered without further dilution or mixed with 0.9% sodium chloride, Lactated Ringer's, or 5% Dextrose injection
• Single-dose vials; discard unused portion of vial
• Diluted IV solution: May store for up to 4 hours at room temperature in polyvinyl chloride bags

General:

• May be used as monotherapy or as adjunctive therapy in patients with partial-onset seizures.
• May initiate therapy with IV or oral administration; clinical experience is limited to 4 consecutive days of IV treatment

Monitor:

• Monitor for suicidal behavior/ideation, changes in mood and behavior
• Monitor for neurological adverse reactions including somnolence and fatigue
• Monitor phenytoin levels if this drug is added or discontinued from ongoing phenytoin therapy

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be instructed on proper administration and advised not to discontinue therapy without consulting with their healthcare provider.
• Patients should be advised that this drug, like other antiepileptic drugs, may increase the risk of suicidal thoughts and behaviors; patients or caregivers should report emergence or worsening of depression, unusual changes in mood or behavior, suicidal thoughts or behavior or thoughts of self-harm to their healthcare provider promptly.
• Patients should be instructed not to drive or perform hazardous tasks until they have sufficient experience with this drug to gauge how it affects them; their performance may be affected by somnolence, dizziness, fatigue, and gait disturbances.
• Women of childbearing potential should be advised to speak with their healthcare provider if they become pregnant or intend to become pregnant during therapy.