Brivaracetam

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION 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 ) 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 ) Injection: for intravenous use only when oral administration is temporarily not feasible; dosing is the same as oral regimen. ( 2.1 , 2.3 ) Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment. ( 2.5 ) 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) Brivaracetam Injection Dosage Brivaracetam injection may be used when oral administration is temporarily not feasible [see Dosage and Administration (2.3) ]. Brivaracetam injection should be administered intravenously at the same dosage and same frequency as Brivaracetam tablets and oral solution. The clinical study experience with Brivaracetam injection is up to 4 consecutive days of treatment. 2.3 Preparation and Administration Instructions for Brivaracetam Injection Brivaracetam injection is for intravenous use only. Preparation Brivaracetam 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 Brivaracetam 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. Brivaracetam 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 Brivaracetam injection vial contents. 2.4 Discontinuation of Brivaracetam Avoid abrupt withdrawal from Brivaracetam in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.6) 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 Brivaracetam dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage) [see Drug Interactions (7.1) and Cli