Briviact Generic Name & Formulations
Legal Class
CV
General Description
Brivaracetam 10mg, 25mg, 50mg, 75mg, 100mg; tabs.
Pharmacological Class
Antiepileptic.
How Supplied
Tabs—60; Oral soln—300mL; Single-dose vials—10
Manufacturer
Generic Availability
NO
Mechanism of Action
The precise mechanism by which Briviact exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.
Briviact Indications
Indications
Partial-onset seizures, as monotherapy or adjunctive treatment.
Briviact Dosage and Administration
Adult
Interchangeable with other forms. Tabs: swallow whole with liquid. Oral soln: use calibrated measuring device. May also give via nasogastric or gastrostomy tube. IV: administer over 2–15mins; limit to 4 consecutive days of treatment. All: adjust dosage based on response and tolerability. ≥16yrs: initially 50mg twice daily; usual maintenance: 25–100mg twice daily. Hepatic impairment: initially 25mg twice daily; max 75mg twice daily. Concomitant rifampin: double brivaracetam dosage.
Children
<1 month: not established. Interchangeable with other forms. Tabs: swallow whole with liquid. Oral soln: use calibrated measuring device. May also give via nasogastric or gastrostomy tube. IV: administer over 2–15mins; limit to 4 consecutive days of treatment. All: adjust dosage based on response and tolerability. 1 month–<16yrs (<11kg): initially 0.75–1.5mg/kg twice daily; usual maintenance: 0.75–3mg/kg twice daily; (11–<20kg): initially 0.5–1.25mg/kg twice daily; usual maintenance: 0.5–2.5mg/kg twice daily; (20–<50kg): initially 0.5–1mg/kg twice daily; usual maintenance: 0.5–2mg/kg twice daily; (≥50kg): initially 25–50mg twice daily; usual maintenance: 25–100mg twice daily. Hepatic impairment (<11kg): initially 0.75mg/kg twice daily; max 2.25mg/kg twice daily; (11–<50kg): initially 0.5mg/kg twice daily; max 2mg/kg twice daily (11–<20kg) or 1.5mg/kg twice daily (20–<50kg); (≥50kg): as Adult. Concomitant rifampin: double brivaracetam dosage.
Briviact Contraindications
Not Applicable
Briviact Boxed Warnings
Not Applicable
Briviact Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal behavior or ideation; monitor for clinical worsening and/or any unusual changes. Monitor for neurological and psychiatric adverse reactions. Discontinue if hypersensitivity reactions occur. Hepatic impairment: adjust dose (see Adult, Children). End-stage renal disease undergoing dialysis: not recommended. Avoid abrupt cessation. Pregnancy. Nursing mothers.
Briviact Pharmacokinetics
Absorption
-
Median Tmax for tablets taken without food: 1 hour (range 0.25 to 3 hours).
-
When a 50 mg tablet was taken with a high-fat meal, Cmax was decreased by 37% and Tmax was delayed by 3 hours, but AUC was unchanged.
Distribution
-
Weakly bound to plasma proteins ≤20%.
-
Volume of distribution: 0.5 L/kg.
Elimination
- Renal (>95%), fecal (<1%). Half-life: ~9 hours.
Briviact Interactions
Interactions
Antagonized by rifampin. Concomitant carbamazepine: may consider dose reduction if intolerant. May potentiate phenytoin; monitor phenytoin levels when adding or discontinuing brivaracetam from ongoing therapy. Concomitant levetiracetam: no added benefit.
Briviact Adverse Reactions
Adverse Reactions
Somnolence/sedation, dizziness, fatigue, nausea/vomiting; hematologic abnormalities.
Briviact Clinical Trials
See Literature
Briviact Note
Notes
To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.
Briviact Patient Counseling
See Literature