Briviact
(Brivaracetam)Dosage & Administration
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Briviact Prescribing Information
Warnings and Precautions (Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with BRIVIACT. Time to onset of the serious dermatologic reaction ranged from 3 to 45 days after BRIVIACT initiation in reported cases. BRIVIACT should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious dermatologic reaction, use of BRIVIACT should not be resumed and alternative therapy should be considered. | 8/2025 |
BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month 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). ()
2.1 Dosage InformationMonotherapy 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.
Table 1: Recommended Dosage for Patients 1 Month of Age and Older 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.
- Pediatric Patients (1 Month to less than 16 Years):The recommended dosage is based on body weight and is administered orally twice daily ()
2.1 Dosage InformationMonotherapy 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.
Table 1: Recommended Dosage for Patients 1 Month of Age and Older 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.
- Injection:for intravenous use only when oral administration is temporarily not feasible; dosing is the same as oral regimen. (,
2.1 Dosage InformationMonotherapy 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.
Table 1: Recommended Dosage for Patients 1 Month of Age and Older 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.
)2.3 Preparation and Administration Instructions for BRIVIACT InjectionBRIVIACT injection is for intravenous use only.
Preparation
BRIVIACT injection can be administered intravenously without further dilution or may be mixed with diluents listed below.
Diluents
0.9% Sodium Chloride injection, USP
Lactated Ringer's injection
5% Dextrose injection, USPAdministration
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.
- Hepatic Impairment:Dose adjustment is recommended for all stages of hepatic impairment. ()
2.5 Patients with Hepatic ImpairmentThe recommended dosage for patients with hepatic impairment is included in Table 2
[see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)].Table 2: Recommended Dosage for Patients with Hepatic Impairment 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 morePediatric 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)
Tablets
- 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.
Oral Solution
- 10 mg/mL: slightly viscous, clear, colorless to yellowish, raspberry-flavored liquid.
Injection
- 50 mg in 5 mL in one single-dose vial. It is a clear, colorless, sterile solution.
Pregnancy: Based on animal data, may cause fetal harm. (
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as BRIVIACT, during pregnancy. Encourage patients who are taking BRIVIACT during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
Risk Summary
Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with BRIVIACT use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Animal Data
Oral administration of brivaracetam (0, 150, 300, or 600 mg/kg/day) to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity. The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day.
Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic. The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD.
When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at the MRD.
Brivaracetam was shown to readily cross the placenta in pregnant rats after a single oral (5 mg/kg) dose of14C-brivaracetam. From 1 hour post dose, radioactivity levels in fetuses, amniotic fluid, and placenta were similar to those measured in maternal blood.
Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT (bronchospasm and angioedema have occurred)
BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported in patients taking BRIVIACT. If a patient develops hypersensitivity reactions after treatment with BRIVIACT, the drug should be discontinued. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients