Tablet
- Strengths
- 10, 25, 50, 75, 100 mg
- Product note
- Swallow whole.
Brivaracetam
Briviact
DailyMed-verified antiseizure indications
Indication / use
- Label / evidence summary
- Briviact: focal-onset (partial-onset) seizures from age 1 month. The IV formulation is a temporary alternative when oral administration is not feasible.
- Role
- Maintenance
- Class
- High-affinity SV2A binding; downstream antiseizure pathway unresolved
Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.
- Briviact tablet/solution U.S. label
Focal seizures · 1 month and older · Maintenance - Briviact IV U.S. label
Focal seizures · 1 month and older · MaintenanceTemporary replacement when oral use is not feasible.
Formulations & strengths
U.S. products unless another country is named. Strengths are per unit or stated volume.
Oral solution
- Strengths
- 10 mg/mL
- Product note
- Use a calibrated oral syringe.
IV injection
- Strengths
- 50 mg/5 mL (10 mg/mL)
- Product note
- IV replacement when oral administration is temporarily not feasible.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- Age ≥16: start 50 mg twice daily; adjust to 25–100 mg twice daily by response/tolerability.
- Pediatric
- <16 years: ≥50 kg start 25–50 mg twice daily, maintenance 25–100 mg twice daily. 20–<50 kg: start 0.5–1, maintenance 0.5–2 mg/kg twice daily. 11–<20 kg: start 0.5–1.25, maintenance 0.5–2.5 mg/kg twice daily. <11 kg: start 0.75–1.5, maintenance 0.75–3 mg/kg twice daily.
- Titration / repeat dosing
- Adults: may start 50 mg twice daily without titration; adjust to 25–100 mg twice daily. Pediatric dosing is weight based and may start without titration; reduce for hepatic impairment.
Dose adjustment & concentrations
- Renal impairment
- No adjustment generally required; not recommended in ESRD on dialysis because data are lacking.
- Hepatic impairment
- Use reduced starting and maximum doses in all stages of hepatic impairment.
- Serum reference information
- 0.2–2 mcg/mL (proposed; no universally validated target)
Safety
- Boxed warning
- No boxed warning.
- Contraindications
- Hypersensitivity to brivaracetam or ingredients.
- Serious precautions & monitoring
- Monitor sedation and psychiatric/behavioral effects; serious dermatologic reactions, bronchospasm and angioedema require prompt assessment.
Common / selected adverse effects
- Somnolence/sedation
- Dizziness
- Fatigue
- Nausea/vomiting
- Irritability
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Carbamazepine | Raises active carbamazepine-epoxide exposure; diplopia, dizziness or ataxia may occur even without a high parent level. | Reduce carbamazepine if toxicity occurs; assess clinical signs and consider epoxide measurement. |
| Phenytoin | Phenytoin concentration may increase. | Check concentrations when adding, changing or stopping brivaracetam. |
| Rifampin / CNS depressants | Rifampin lowers brivaracetam exposure; sedatives add impairment. | Adjust brivaracetam per label with rifampin; assess sedation and seizure control. |
Pregnancy & contraception
- Fetal / neonatal risk
- Human brivaracetam pregnancy data are insufficient to establish the risk of malformations, miscarriage or other adverse outcomes. Animal studies found developmental toxicity at exposures above those used clinically.
- Contraception
- At 50 mg twice daily, brivaracetam did not meaningfully alter ethinylestradiol/levonorgestrel exposure. At 400 mg/day (above the approved maximum), hormone exposure fell by 27%/23% without loss of ovulation suppression.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Direct pivotal trial
Trial summary
- Study design / duration
- Three randomized, double-blind, placebo-controlled, fixed-dose adjunctive focal-seizure trials in adults, generally with 8-week baseline and 12-week treatment without titration; seizure-frequency reduction was primary.
- Primary endpoint
- Adjunctive focal-seizure frequency reduction versus placebo; responder threshold ≥50% reduction from baseline. N01252 did not meet its prespecified sequential primary analysis.
- Results
- N01358 (100/200 mg/day): placebo-adjusted seizure-frequency reductions 22.8%/23.2%; responder rates 38.9%/37.8% versus 21.6% placebo. N01253 (50 mg/day): responder rate 32.7% versus 16.7%. These are separate trials, not pooled estimates.
- Confidence intervals
- N01358: 95% CIs for placebo-adjusted frequency reduction were 13.3–31.2% (100 mg/day) and 13.8–31.6% (200 mg/day).
- Discontinuations
- N01358 adverse-event discontinuations: 8.3% at 100 mg/day, 6.8% at 200 mg/day and 3.8% placebo.
- Exposure duration
- Each of the three trials used an 8-week baseline and 12-week randomized treatment without up-titration.
Trial publications
Mechanism of action
- Binds synaptic vesicle protein 2A (SV2A) with high affinity and selectivity; SV2A participates in synaptic vesicle function and transmitter release.
- SV2A binding is well characterized and may contribute to seizure control, but the full causal pathway is unresolved. Binding affinity alone does not establish greater clinical efficacy than levetiracetam.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- Rapid, almost complete oral absorption. Tablet, oral solution and IV formulations provide comparable systemic exposure.
- Elimination half-life
- Approximately 9 hours (terminal plasma half-life).
- Volume of distribution
- Approximately 0.5 L/kg.
- Active metabolite(s)
- None: the carboxylic acid, hydroxy and hydroxy-acid metabolites are pharmacologically inactive.
- Active-metabolite half-life
- Not applicable — no clinically established active metabolite.
- Protein binding
- ≤20%
- Metabolism / elimination
- Primarily hydrolysis; secondary CYP2C19 hydroxylation
Hepatic impairment raises exposure; refer to the separate dose-adjustment section.
Molecular structure
NIH PubChem structure and record ↗
Product history
- Initial U.S. approval
- 2016
- Brands
- Briviact
- Manufacturer / marketer
- UCB (Briviact)
- Generic availability
- No widely marketed U.S. generic
- Related drugs
- Close pharmacologic relative of levetiracetam; both bind SV2A.
Sources & review status
Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: 4/2026. This is a draft reference; final review is pending.