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Briviact Dosage

Generic name: brivaracetam 10mg
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on May 5, 2020.

Dosage Information

Monotherapy or Adjunctive Therapy

The recommended dosage for adults and pediatric patients 4 years of age and older is included in Table 1. In pediatric patients 4 years to less than 16 years of age, the recommended dosing regimen is dependent upon body weight and is only recommended to be administered orally. When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability.

Table 1: Recommended Dosage for Adults and Pediatric Patients 4 Years 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 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 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)

BRIVIACT Injection Dosage in Adult Patients (16 years and older)

BRIVIACT injection may be used for adult patients when oral administration is temporarily not feasible [see Dosage and Administration (2.3)]. BRIVIACT injection should be administered intravenously to adult patients at the same dosage and same frequency as BRIVIACT tablets and oral solution. The use of BRIVIACT injection in pediatric patients has not been studied.

The clinical study experience with BRIVIACT injection is limited to 4 consecutive days of treatment.

Administration Instructions for BRIVIACT Tablets and BRIVIACT Oral Solution

BRIVIACT can be initiated with either intravenous or oral administration.

BRIVIACT tablets and oral solution may be taken with or without food.

BRIVIACT Tablets

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.

Preparation and Administration Instructions for BRIVIACT Injection for Adult Patients

BRIVIACT 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, USP

Administration

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.

Discontinuation of BRIVIACT

Avoid abrupt withdrawal from BRIVIACT in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.5) and Clinical Studies (14)].

Patients with Hepatic Impairment

For all stages of hepatic impairment, the recommended starting dosage for adults and pediatric patients weighing 50 kg or more is 25 mg twice daily (50 mg per day), and the recommended maximum dosage is 75 mg twice daily (150 mg per day). The recommended starting dosage for pediatric patients with hepatic impairment weighing 11 kg to less than 50 kg is 0.5 mg/kg twice daily (1 mg/kg per day). The maximum dosage for pediatric patients with hepatic impairment weighing 20 kg to less than 50 kg is 1.5 mg/kg twice daily (3 mg/kg per day). The maximum dosage for pediatric patients with hepatic impairment weighing 11 kg to less than 20 kg is 2 mg/kg twice daily (4 mg/kg per day) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Co-administration with Rifampin

Increase the BRIVIACT dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.