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Brivaracetam: Pediatric drug information

Brivaracetam: Pediatric drug information
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For additional information see "Brivaracetam: Drug information" and "Brivaracetam: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Briviact
Brand Names: Canada
  • APO-Brivaracetam;
  • AURO-Brivaracetam;
  • Brivlera
Therapeutic Category
  • Antiseizure Agent, Miscellaneous
Dosing: Pediatric
Partial-onset seizures; adjunct or monotherapy

Partial-onset seizures; adjunct or monotherapy:

Note: Avoid abrupt withdrawal; decrease dose gradually. Use injection when oral administration is temporarily not feasible; clinical study experience with brivaracetam injection is limited to 4 consecutive days of treatment.

Infants, Children, and Adolescents <16 years:

<11 kg: Oral, IV: Initial: 0.75 to 1.5 mg/kg/dose twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 6 mg/kg/day in 2 divided doses.

11 to <20 kg: Oral, IV: Initial: 0.5 to 1.25 mg/kg/dose twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 5 mg/kg/day in 2 divided doses.

20 kg to <50 kg: Oral, IV: Initial: 0.5 to 1 mg/kg/dose twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 4 mg/kg/day in 2 divided doses.

≥50 kg: Oral, IV: Initial: 25 to 50 mg twice daily; adjust dose based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 200 mg/day in 2 divided doses.

Adolescents ≥16 years: Oral, IV: Initial: 50 mg twice daily; may decrease to 25 mg twice daily or increase up to 100 mg twice daily based on individual patient response and tolerability (gradual dose escalation not required); maximum daily dose: 200 mg/day in 2 divided doses.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents: Oral, IV:

Mild to severe impairment: No dosage adjustment necessary.

End-stage renal disease requiring dialysis: Use is not recommended (has not been studied).

Dosing: Liver Impairment: Pediatric

Mild to severe impairment:

Infants, Children, and Adolescents <16 years: Oral, IV:

<11 kg: Initial: 0.75 mg/kg/dose twice daily; maximum daily dose 4.5 mg/kg/day in 2 divided doses.

11 to <20 kg: Initial: 0.5 mg/kg/dose twice daily; maximum daily dose: 4 mg/kg/day in 2 divided doses.

20 kg to <50 kg: Initial: 0.5 mg/kg/dose twice daily; maximum daily dose: 3 mg/kg/day in 2 divided doses.

≥50 kg: Initial: 25 mg twice daily; maximum daily dose: 150 mg/day in 2 divided doses.

Adolescents ≥16 years: Oral, IV: Initial: 25 mg twice daily; maximum daily dose: 150 mg/day in 2 divided doses.

Dosing: Adult

(For additional information see "Brivaracetam: Drug information")

Partial-onset seizures

Partial-onset seizures (monotherapy or adjunctive therapy): Oral, IV: Initial: 50 mg twice daily; may decrease to 25 mg twice daily or increase up to 100 mg twice daily based on individual patient response and tolerability (maximum: 200 mg/day). Note: Use injection when oral administration is temporarily not feasible; clinical study experience with brivaracetam injection is limited to 4 consecutive days of treatment.

Status epilepticus, refractory

Status epilepticus, refractory (off-label use):

Loading dose: IV: 50 to 400 mg as a single dose (Ref). Doses greater than or equal to ~2 mg/kg may be associated with a higher likelihood of status epilepticus resolution (Ref).

Maintenance dose: IV: 100 to 400 mg/day administered in 2 divided doses (Ref).

Discontinuation of therapy: Reduce gradually; it has been recommended to reduce the dose by 50 mg/day on a weekly basis with the final week of treatment at the dose of 20 mg/day (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Mild to severe impairment: No dosage adjustment necessary.

End-stage renal disease requiring dialysis: Use is not recommended (has not been studied).

Dosing: Liver Impairment: Adult

Mild to severe impairment (Child Pugh classes A, B, and C): Initial: 25 mg twice daily, up to a maximum of 75 mg twice daily.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Nervous system: Dizziness (12%), drowsiness (≤16%), psychiatric disturbance (13%; includes psychotic and nonpsychotic), sedated state (≤16%)

1% to 10%:

Gastrointestinal: Constipation (2%), dysgeusia (≥3%), nausea (≤5%), vomiting (≤5%)

Hematologic & oncologic: Decreased white blood cell count (2%)

Local: Infusion site pain (≥3%)

Nervous system: Ataxia (≤3%), balance impairment (≤3%), euphoria (≥3%), fatigue (9%), intoxicated feeling (≥3%), irritability (3%)

Ophthalmic: Nystagmus disorder (≤3%)

<1%: Hematologic & oncologic: Decreased neutrophils

Frequency not defined:

Gastrointestinal: Decreased appetite

Nervous system: Abnormal gait, hypersomnia, lethargy, malaise, suicidal ideation, vertigo

Neuromuscular & skeletal: Asthenia

Postmarketing:

Hypersensitivity: Angioedema

Respiratory: Bronchospasm

Contraindications

Hypersensitivity to brivaracetam or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression (impaired coordination, ataxia, abnormal gait, dizziness and dose-related fatigue, and somnolence), which may impair physical or mental abilities. Risk is greatest early in treatment, but may occur at any time. Patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

• Hematologic effects: May cause hematologic abnormalities; significant decreased white blood cell count (<3.0 x 109/L) and decreased neutrophil count (<1.0 x 109/L) have been reported.

• Hypersensitivity: Bronchospasm and angioedema have been reported. Discontinue therapy if a hypersensitivity reaction develops. Multiorgan hypersensitivity syndrome (also known as Drug Rash Eosinophilia and Systemic Symptoms or DRESS), is a serious condition sometimes induced by antiseizure drugs. DRESS initially presents with fever and rash, then with other organ system involvement that may include eosinophilia, lymphadenopathy, hepatitis, nephritis, and/or myocarditis. If any of these hypersensitivity reactions are suspected and an alternative cause cannot be established, discontinue brivaracetam.

• Psychiatric symptoms: Psychosis, paranoia, hallucinations, and behavioral symptoms (including abnormal behavior, adjustment disorder, affect liability, aggression, agitation, altered mood, anger, anxiety, apathy, belligerence, depression, irritability, mood swings, nervousness, psychomotor hyperactivity, restlessness, and tearfulness) may occur; clinical trials reported events in 13% of adult patients receiving brivaracetam compared with 8% receiving placebo (adverse events in pediatric patients were similar to those observed in adult patients).

• Suicidal ideation: Pooled analysis of trials involving various antiseizure medications (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared with 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials ≤24 weeks). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify the health care provider immediately if symptoms occur.

Disease-related concerns:

• Hepatic impairment: Use caution in patients with hepatic impairment; dosage adjustment recommended.

• Renal impairment: Not recommended in patients with end-stage renal disease (ESRD) undergoing dialysis.

Special populations:

• CYP2C19 poor metabolizers: Poor metabolizers of CYP2C19 may require dose reduction.

Other warnings/precautions:

• Withdrawal: Antiseizure medications should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Briviact: 50 mg/5 mL (5 mL)

Solution, Oral:

Briviact: 10 mg/mL (300 mL) [contains methylparaben; raspberry flavor]

Tablet, Oral:

Briviact: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg

Generic Equivalent Available: US

No

Pricing: US

Solution (Briviact Intravenous)

50 mg/5 mL (per mL): $15.15

Solution (Briviact Oral)

10 mg/mL (per mL): $5.89

Tablets (Briviact Oral)

10 mg (per each): $29.46

25 mg (per each): $29.46

50 mg (per each): $29.46

75 mg (per each): $29.46

100 mg (per each): $29.46

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Brivlera: 50 mg/5 mL (5 mL)

Solution, Oral:

Brivlera: 10 mg/mL (300 mL) [contains methylparaben]

Tablet, Oral:

Brivlera: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg

Generic: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg

Controlled Substance

C-V

Administration: Pediatric

Oral: Administer with or without food.

Oral solution: Use a calibrated measuring device to measure (household teaspoon or tablespoon is not an adequate measuring device). May also be administered using a nasogastric tube or gastrostomy tube.

Tablets: Swallow tablets whole with liquid; do not chew or crush.

Parenteral: IV: Administer IV over 2 to 15 minutes; may administer undiluted or diluted with NS, LR, or D5W.

Administration: Adult

IV: Administer IV over 2 to 15 minutes; may administer undiluted or diluted with NS, LR, or D5W.

Oral solution: Administer with or without food. Use a calibrated measuring device to measure (household teaspoon or tablespoon is not an adequate measuring device). May also be administered using a nasogastric tube or gastrostomy tube.

Tablets: Administer with or without food. Swallow tablets whole with liquid; do not chew or crush.

Storage/Stability

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Oral solution: Do not freeze. Discard any oral solution remaining after 5 months of first opening the bottle.

Injection: Do not freeze. May store solution diluted in NS, LR, or D5W for ≤4 hours at room temperature in polyvinyl chloride (PVC) bags. Discard any unused portion.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Briviact: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205836s014,205837s011,205838s011lbl.pdf#page=18

Use

Treatment of partial-onset seizures, adjunctive or monotherapy (FDA approved in ages ≥1 month and adults).

Medication Safety Issues
Sound-alike/look-alike issues:

Briviact may be confused with Brilinta

Metabolism/Transport Effects

Substrate of CYP2C19 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Acrivastine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Alcohol (Ethyl): May increase CNS depressant effects of Brivaracetam. Risk C: Monitor

Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification

Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification

Brexanolone: CNS Depressants may increase CNS depressant effects of Brexanolone. Risk C: Monitor

Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification

BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor

CarBAMazepine: May decrease serum concentration of Brivaracetam. Brivaracetam may increase active metabolite exposure of CarBAMazepine. Risk C: Monitor

Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification

Chloral Hydrate/Chloral Betaine: CNS Depressants may increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification

Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification

Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

CNS Depressants: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

CYP2C19 Inducers (Moderate): May decrease serum concentration of Brivaracetam. Risk C: Monitor

CYP2C19 Inducers (Strong): May decrease serum concentration of Brivaracetam. Management: Increase the brivaracetam dose by up to 100% (ie, double the dose) if used with rifampin and consider the same dose adjustment if used with other strong CYP2C19 inducers. Monitor for reduced brivaracetam efficacy. Risk D: Consider Therapy Modification

CYP2C19 Inhibitors (Moderate): May increase serum concentration of Brivaracetam. Risk C: Monitor

CYP2C19 Inhibitors (Strong): May increase serum concentration of Brivaracetam. Risk C: Monitor

Dantrolene: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Daridorexant: May increase CNS depressant effects of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Desmopressin: Hyponatremia-Associated Agents may increase hyponatremic effects of Desmopressin. Risk C: Monitor

DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification

Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Difenoxin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor

Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Doxylamine: CNS Depressants may increase CNS depressant effects of Doxylamine. Risk C: Monitor

DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification

Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor

Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Esketamine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid

Flunitrazepam: CNS Depressants may increase CNS depressant effects of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider Therapy Modification

Fosphenytoin-Phenytoin: Brivaracetam may increase serum concentration of Fosphenytoin-Phenytoin. Fosphenytoin-Phenytoin may decrease serum concentration of Brivaracetam. Risk C: Monitor

HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification

Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Lemborexant: May increase CNS depressant effects of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider Therapy Modification

LevETIRAcetam: May decrease therapeutic effects of Brivaracetam. Specifically, the therapeutic effect of brivaracetam may be diminished and/or negligible when given to patients already receiving levetiracetam. Management: Consider alternatives to the combined use of levetiracetam and brivaracetam due to an apparent lack of brivaracetam effectiveness in patients receiving levetiracetam. Risk D: Consider Therapy Modification

Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofepramine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification

Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor

Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mefloquine: May decrease therapeutic effects of Antiseizure Agents. Mefloquine may decrease serum concentration of Antiseizure Agents. Management: Mefloquine is contraindicated for malaria prophylaxis in persons with a history of seizures. If antiseizure drugs are being used for another indication, monitor antiseizure drug concentrations and treatment response closely with concurrent use. Risk D: Consider Therapy Modification

Melitracen [INT]: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification

Methoxyflurane: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

MetyraPONE: Coadministration of Antiseizure Agents and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking antiseizure agents. Risk D: Consider Therapy Modification

MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor

Mianserin: May decrease therapeutic effects of Antiseizure Agents. Risk C: Monitor

Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Nalfurafine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid

Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Orlistat: May decrease serum concentration of Antiseizure Agents. Risk C: Monitor

Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid

Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Oxybate Salt Products: CNS Depressants may increase CNS depressant effects of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider Therapy Modification

OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Paliperidone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid

Perampanel: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

PHENobarbital: May decrease serum concentration of Brivaracetam. Risk C: Monitor

Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor

Pizotifen: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor

Primidone: May decrease serum concentration of Brivaracetam. Risk C: Monitor

Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification

ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor

Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor

Suvorexant: CNS Depressants may increase CNS depressant effects of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid

Trimeprazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Zolpidem: CNS Depressants may increase CNS depressant effects of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider Therapy Modification

Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification

Food Interactions

Food may delay but does not affect the extent of absorption. Management: Administer without regard to meals.

Pregnancy Considerations

Brivaracetam crosses the placenta (Landmark 2021).

Outcome data following maternal use of brivaracetam during pregnancy are available from case reports (Landmark 2021; Navarro 2023; Paolini 2020).

Data collection to monitor pregnancy and infant outcomes following exposure to brivaracetam is ongoing. Patients exposed to brivaracetam during pregnancy are encouraged to enroll themselves into the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. Additional information is available at http://www.aedpregnancyregistry.org.

Monitoring Parameters

CBC with differential, liver and renal function, and symptoms of depression and suicidality (eg, anxiety, depression, behavior changes); growth parameters in pediatric patients (may cause decreased appetite).

Mechanism of Action

The precise mechanism by which brivaracetam exerts its antiseizure activity is unknown. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the antiseizure effect.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: Rapidly and almost completely absorbed; delayed by 3 hours with a high-fat meal

Distribution: 0.5 L/kg

Protein binding: ≤20% to plasma proteins

Metabolism: Hepatic and extrahepatic amidase mediated hydrolysis of the amide moiety to form carboxylic acid metabolite (primary route) and hydroxylation primarily by CYP2C19 to form the hydroxy metabolite (secondary route). Metabolites are inactive, including an additional hydroxy acid metabolite.

Half-life elimination: ~9 hours

Time to peak: Oral: 1 hour (fasting, range: 0.25 to 3 hours)

Excretion: Urine (>95%; <10% unchanged); feces (<1%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: In adult patients with creatinine clearance <30 mL/minute/1.73 m2 not requiring dialysis, plasma AUC of brivaracetam was moderately increased (21%), while the AUCs of the acid, hydroxy, and hydroxyacid metabolites were increased 3-fold, 4-fold, and 21-fold, respectively. Renal clearance of these inactive metabolites was decreased 10-fold.

Hepatic function impairment: In adult patients with hepatic cirrhosis, Child-Pugh classes A, B, and C, showed 50%, 57%, and 59% increases in brivaracetam exposure, respectively; the effect of hepatic impairment is expected to be comparable in pediatric patients.

Older adult: Plasma half-life was 7.9 hours and 9.3 hours in the 65 to 75 and >75 years of age groups, respectively. Steady-state plasma clearance was slightly lower than in younger patients.

CYP2C19 poor metabolizers: In patients possessing genetic variations in CYP2C19, production of the hydroxy metabolite is decreased 2-fold or 10-fold, and the blood level of brivaracetam itself is increased by 22% or 42%, respectively, in individuals with one or both mutated alleles.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Briviact;
  • (AR) Argentina: Brivaxon | Briviact;
  • (AT) Austria: Briviact;
  • (AU) Australia: Briviact;
  • (BD) Bangladesh: Bivara | Bricet | Briva | Epicure;
  • (BE) Belgium: Briviact;
  • (BG) Bulgaria: Briviact;
  • (BR) Brazil: Brivlera;
  • (CH) Switzerland: Briviact;
  • (CO) Colombia: Brivaxon | Briviact;
  • (CZ) Czech Republic: Briviact;
  • (DE) Germany: Briviact;
  • (EC) Ecuador: Brivaxon;
  • (EE) Estonia: Briviact;
  • (EG) Egypt: Brivafutal | Convarsiotam;
  • (ES) Spain: Briviact;
  • (FI) Finland: Briviact;
  • (FR) France: Briviact;
  • (GB) United Kingdom: Briviact;
  • (GR) Greece: Briviact;
  • (HK) Hong Kong: Briviact;
  • (HU) Hungary: Briviact;
  • (IE) Ireland: Briviact;
  • (IN) India: Bevicet | Bevitam | Biva | Brecita | Bricet | Brinda | Bripca | Britam | Britzilam | Britzilam sr | Briv | Brivahenz | Brivajoy | Brivalex | Brivalyst | Brivanext | Brivapride | Brivasure | Brivatab | Brivatop | Brivazen | Brivepsy | Brivgard | Briviact | Brivissa | Brivup | Froyad;
  • (IT) Italy: Briviact | Nubriveo;
  • (KR) Korea, Republic of: Briviact;
  • (KW) Kuwait: Briviact;
  • (LB) Lebanon: Briviact;
  • (LT) Lithuania: Briviact;
  • (LU) Luxembourg: Briviact;
  • (LV) Latvia: Briviact;
  • (MX) Mexico: Briviact;
  • (NL) Netherlands: Briviact;
  • (NO) Norway: Briviact;
  • (PA) Panama: Brivaxon;
  • (PE) Peru: Brivaxon;
  • (PK) Pakistan: Brivatam | Brivera;
  • (PL) Poland: Briviact;
  • (PR) Puerto Rico: Briviact;
  • (PT) Portugal: Briviact;
  • (QA) Qatar: Briviact;
  • (RO) Romania: Briviact;
  • (RU) Russian Federation: Briviact;
  • (SA) Saudi Arabia: Briviact;
  • (SE) Sweden: Briviact;
  • (SI) Slovenia: Briviact;
  • (SK) Slovakia: Briviact;
  • (TW) Taiwan: Briviact
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