Briviact

BRIVIACT- brivaracetam tablet, film coated
BRIVIACT- brivaracetam solution
BRIVIACT- brivaracetam injection, suspension
UCB, Inc.

1 INDICATIONS AND USAGE

BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

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.

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.

2.2 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.

2.3 Preparation and Administration Instructions for BRIVIACT Injection

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.

2.4 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)].

2.5 Patients with Hepatic Impairment

The 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 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)

2.6 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)].

3 DOSAGE FORMS AND STRENGTHS

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.

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