The approval covers all three brivaracetam (BRIVIACT) formulations (tablets, oral solution, and IV) and marks the first time the IV formulation will be available for children.
Dosage:
- Dose for 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).
- Pediatric Patients (1 Month to less than 16 Years): The recommended
dosage is based on body weight and is administered orally twice daily.
Adverse reaction: Most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting.
Source: UCB