BRIVIACT- brivaracetam tablet, film coated
BRIVIACT- brivaracetam solution
BRIVIACT- brivaracetam injection, suspension
BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Monotherapy or Adjunctive Therapy
The recommended dosage for patients 1 month of age and older is included in Table 1. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability.
|Age and Body Weight||Initial Dosage||Minimum and Maximum Maintenance Dosage|
| Adults (16 years and older)||50 mg twice daily(100 mg per day)||25 mg to 100 mg twice daily(50 mg to 200 mg per day)|
|Pediatric patients weighing 50 kg or more||25 mg to 50 mg twice daily(50 mg to 100 mg per day)||25 mg to 100 mg twice daily(50 mg to 200 mg per day)|
|Pediatric patients weighing 20 kg to less than 50 kg||0.5 mg/kg to 1 mg/kg twice daily(1 mg/kg to 2 mg/kg per day)||0.5 mg/kg to 2 mg/kg twice daily(1 mg/kg to 4 mg/kg per day)|
|Pediatric patients weighing 11 kg to less than 20 kg||0.5 mg/kg to 1.25 mg/kg twice daily(1 mg/kg to 2.5 mg/kg per day)||0.5 mg/kg to 2.5 mg/kg twice daily(1 mg/kg to 5 mg/kg per day)|
|Pediatric patients weighing less than 11 kg||0.75 mg/kg to 1.5 mg/kg twice daily(1.5 mg/kg to 3 mg/kg per day)||0.75 mg/kg to 3 mg/kg twice daily(1.5 mg/kg to 6 mg/kg per day)|
BRIVIACT Injection Dosage
BRIVIACT injection may be used when oral administration is temporarily not feasible [see Dosage and Administration (2.3)]. BRIVIACT injection should be administered intravenously at the same dosage and same frequency as BRIVIACT tablets and oral solution.
The clinical study experience with BRIVIACT injection is up to 4 consecutive days of treatment.
BRIVIACT can be initiated with either intravenous or oral administration.
BRIVIACT tablets and oral solution may be taken with or without food.
BRIVIACT tablets should be swallowed whole with liquid. BRIVIACT tablets should not be chewed or crushed.
BRIVIACT Oral Solution
A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.
When using BRIVIACT oral solution, no dilution is necessary. BRIVIACT oral solution may also be administered using a nasogastric tube or gastrostomy tube.
Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle.
BRIVIACT injection is for intravenous use only.
BRIVIACT injection can be administered intravenously without further dilution or may be mixed with diluents listed below.
- 0.9% Sodium Chloride injection, USP
- Lactated Ringer’s injection
- 5% Dextrose injection, USP
BRIVIACT 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. BRIVIACT injection is for single dose only.
Storage and Stability
The diluted solution should not be stored for more than 4 hours at room temperature and may be stored in polyvinyl chloride (PVC) bags. Discard any unused portion of the BRIVIACT injection vial contents.
|Age and Body Weight||Initial Dosage||Maximum Maintenance Dosage|
|Adults (16 years and older)||25 mg twice daily(50 mg per day)||75 mg twice daily(150 mg per day)|
|Pediatric patients weighing 50 kg or more|
|Pediatric patients weighing 20 kg to less than 50 kg||0.5 mg/kg twice daily(1 mg/kg per day)||1.5 mg/kg twice daily(3 mg/kg per day)|
|Pediatric patients weighing 11 kg to less than 20 kg||0.5 mg/kg twice daily(1 mg/kg per day)||2 mg/kg twice daily(4 mg/kg per day)|
|Pediatric patients weighing less than 11 kg||0.75 mg/kg twice daily(1.5 mg/kg per day)||2.25 mg/kg twice daily(4.5 mg/kg per day)|
- 10 mg: white to off white, round, film-coated, and debossed with “u10” on one side.
- 25 mg: grey, oval, film-coated, and debossed with “u25” on one side.
- 50 mg: yellow, oval, film-coated, and debossed with “u50” on one side.
- 75 mg: purple, oval, film-coated, and debossed with “u75” on one side.
- 100 mg: green-grey, oval, film-coated, and debossed with “u100” on one side.
- 10 mg/mL: slightly viscous, clear, colorless to yellowish, raspberry-flavored liquid.
- 50 mg in 5 mL in one single-dose vial. It is a clear, colorless, sterile solution.
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