brivaracetam (Rx)

Brand and Other Names:Briviact

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule V

  • 10mg
  • 25mg
  • 50mg
  • 75mg
  • 100mg

oral solution: Schedule V

  • 10mg/mL

injection, solution: Schedule V

  • 50mg/5mL single-dose vial

Partial-Onset Seizures

Indicated for partial-onset seizures

50 mg PO/IV q12hr initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO/IV BID (50-200 mg/day)

Injection may be used for patients when oral administration is temporarily not feasible; clinical study experience with injection is limited to 4 consecutive days of treatment

Dosage Modifications

Hepatic impairment

  • All stages: Decrease starting dose to 25 mg BID and do not exceed 75 mg BID (150 mg/day)

Renal impairment

  • Mild-to-moderate: No dose adjustment required
  • ESRD undergoing dialysis: Not studied

Coadministration with rifampin

  • Increase dose by 100% (ie, double dose)

Dosing Considerations

IV injection may be used when PO administration is temporarily not feasible; injection should be administered at the same dosage and same frequency as tablets or oral solution; clinical trials limited IV administration to 4 consecutive days

Dosage Forms & Strengths

tablet: Schedule V

  • 10mg
  • 25mg
  • 50mg
  • 75mg
  • 100mg

oral solution: Schedule V

  • 10mg/mL

injection, solution: Schedule V

  • 50mg/5mL

Partial Onset Seizures

Tablets or oral solution

  • Indicated for partial-onset seizures in children and adolescents ≥4 years
  • <1 month : Safety and efficacy not established
  • ≥1 month to <16 years

    • <11 kg: 0.75-1.5 mg/kg PO/IV BID (1.5-3 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 0.75-3 mg/kg PO/IV BID (1.5-6 mg/kg/day)
    • 11 to <20 kg: 0.5-1.25 mg/kg PO/IV BID (1-2.5 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 0.5-2.5 mg/kg PO/IV BID (1-5 mg/kg/day)
    • 20 to <50 kg: 0.5-1 mg/kg PO/IV BID (1-2 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 0.5-2 mg/kg PO/IV BID (1-4 mg/kg/day)
    • ≥50 kg: 25-50 mg PO/IV BID (50-100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between 25-100 mg PO/IV BID (50-200 mg/day)
  • ≥16 years

    • 50 mg PO/IV BID (100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO/IV BID (50-200 mg/day)

Dosage Modifications

Hepatic impairment

  • Starting dose adjustments
    • <11 kg: Start at 0.75 mg/kg PO/IV BID (1.5 mg/kg/day)
    • 11 to <50 kg: Start at 0.5 mg/kg PO/IV BID (1 mg/kg/day)
    • ≥50 kg: Start at 25 mg PO/IV BID (50 mg/day)
  • Maximum dose with hepatic impairment
    • <11 kg: Not to exceed 2.25 mg/kg PO/IV BID (4.5 mg/kg/day)
    • 11 to <20 kg: Not to exceed 2 mg/kg PO/IV BID (4 mg/kg/day)
    • 20 to <50 kg: Not to exceed 1.5 mg/kg PO/IV BID (3 mg/kg/day)
    • ≥50 kg: Not to exceed 75 mg PO/IV BID (150 mg/day)

Renal impairment

  • Mild-to-moderate: No dose adjustment required
  • ESRD undergoing dialysis: Not studied

Coadministration with rifampin

  • Increase dose by 100% (ie, double dose)

Dosing Considerations

IV injection may be used when PO administration is temporarily not feasible; injection should be administered at the same dosage and same frequency as tablets or oral solution; clinical trials limited IV administration to 4 consecutive days

Avoid abrupt withdrawal in order to minimize the risk of increased seizure frequency and status epilepticus

Absence Epilepsy (Orphan)

Orphan designation for treatment of juvenile or childhood absence epilepsy

Sponsor

  • UCB, Inc; 1950 Lake Park Drive, Building 2100; Smyrna, Georgia

In general, dose selection for an elderly patient should be judicious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

Refer to Adult Dosing

Next:

Interactions

Interaction Checker

and brivaracetam

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            Contraindicated (1)

            • thalidomide

              brivaracetam and thalidomide both increase sedation. Contraindicated.

            Serious - Use Alternative (21)

            • alfentanil

              brivaracetam and alfentanil both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • buprenorphine

              brivaracetam and buprenorphine both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • buprenorphine buccal

              brivaracetam and buprenorphine buccal both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • buprenorphine subdermal implant

              brivaracetam and buprenorphine subdermal implant both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • buprenorphine transdermal

              brivaracetam and buprenorphine transdermal both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • buprenorphine, long-acting injection

              brivaracetam and buprenorphine, long-acting injection both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • fentanyl

              brivaracetam and fentanyl both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • fentanyl intranasal

              brivaracetam and fentanyl intranasal both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • fentanyl iontophoretic transdermal system

              brivaracetam and fentanyl iontophoretic transdermal system both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • fentanyl transdermal

              brivaracetam and fentanyl transdermal both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • fentanyl transmucosal

              brivaracetam and fentanyl transmucosal both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • hydrocodone

              brivaracetam and hydrocodone both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • hydromorphone

              brivaracetam and hydromorphone both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • lonafarnib

              lonafarnib will increase the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Lonafarnib may increase the AUC and peak concentration of CYP2C19 substrates. If coadministration unavoidable, monitor for adverse reactions and reduce the CYP2C19 substrate dose in accordance with its approved product labeling.

            • methadone

              brivaracetam and methadone both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • metoclopramide intranasal

              brivaracetam, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

            • morphine

              brivaracetam and morphine both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • oxycodone

              brivaracetam and oxycodone both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • oxymorphone

              brivaracetam and oxymorphone both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • remifentanil

              brivaracetam and remifentanil both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

            • selinexor

              selinexor, brivaracetam. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            Monitor Closely (170)

            • acetaminophen/phenyltoloxamine

              brivaracetam and acetaminophen/phenyltoloxamine both increase sedation. Use Caution/Monitor.

            • acrivastine

              acrivastine and brivaracetam both increase sedation. Use Caution/Monitor.

            • alprazolam

              brivaracetam and alprazolam both increase sedation. Use Caution/Monitor.

            • amisulpride

              amisulpride and brivaracetam both increase sedation. Use Caution/Monitor.

            • amitriptyline

              brivaracetam and amitriptyline both increase sedation. Use Caution/Monitor.

            • amobarbital

              brivaracetam and amobarbital both increase sedation. Use Caution/Monitor.

            • amoxapine

              brivaracetam and amoxapine both increase sedation. Use Caution/Monitor.

            • aripiprazole

              brivaracetam and aripiprazole both increase sedation. Use Caution/Monitor.

            • asenapine

              asenapine and brivaracetam both increase sedation. Use Caution/Monitor.

            • asenapine transdermal

              asenapine transdermal and brivaracetam both increase sedation. Use Caution/Monitor.

            • avapritinib

              avapritinib and brivaracetam both increase sedation. Use Caution/Monitor.

            • baclofen

              brivaracetam and baclofen both increase sedation. Use Caution/Monitor.

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen and brivaracetam both increase sedation. Use Caution/Monitor.

            • brexanolone

              brexanolone, brivaracetam. Either increases toxicity of the other by sedation. Use Caution/Monitor.

            • brexpiprazole

              brexpiprazole and brivaracetam both increase sedation. Use Caution/Monitor.

            • brimonidine

              brimonidine and brivaracetam both increase sedation. Use Caution/Monitor.

              brivaracetam and brimonidine both increase sedation. Use Caution/Monitor.

            • brompheniramine

              brivaracetam and brompheniramine both increase sedation. Use Caution/Monitor.

            • buprenorphine subdermal implant

              buprenorphine subdermal implant and brivaracetam both increase sedation. Use Caution/Monitor.

            • butabarbital

              brivaracetam and butabarbital both increase sedation. Use Caution/Monitor.

            • butalbital

              brivaracetam and butalbital both increase sedation. Use Caution/Monitor.

            • butorphanol

              brivaracetam and butorphanol both increase sedation. Use Caution/Monitor.

            • carbamazepine

              carbamazepine will decrease the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Brivaracetam plasma concentration decreased by 26%.

              brivaracetam, carbamazepine. decreasing metabolism. Use Caution/Monitor. Brivaracetam reversibly inhibits epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine. The carbamazepine epoxide plasma concentration increased up to 198%. May require carbamazepine dose reduction. .

            • carbinoxamine

              brivaracetam and carbinoxamine both increase sedation. Use Caution/Monitor.

            • cariprazine

              brivaracetam and cariprazine both increase sedation. Use Caution/Monitor.

            • carisoprodol

              brivaracetam and carisoprodol both increase sedation. Use Caution/Monitor.

            • cenobamate

              cenobamate, brivaracetam. Either increases effects of the other by sedation. Use Caution/Monitor.

            • cetirizine

              brivaracetam and cetirizine both increase sedation. Use Caution/Monitor.

            • chlordiazepoxide

              brivaracetam and chlordiazepoxide both increase sedation. Use Caution/Monitor.

            • chlorpheniramine

              brivaracetam and chlorpheniramine both increase sedation. Use Caution/Monitor.

            • chlorpromazine

              brivaracetam and chlorpromazine both increase sedation. Use Caution/Monitor.

            • chlorzoxazone

              brivaracetam and chlorzoxazone both increase sedation. Use Caution/Monitor.

            • clemastine

              brivaracetam and clemastine both increase sedation. Use Caution/Monitor.

            • clobazam

              brivaracetam and clobazam both increase sedation. Use Caution/Monitor.

            • clomipramine

              brivaracetam and clomipramine both increase sedation. Use Caution/Monitor.

            • clonazepam

              brivaracetam and clonazepam both increase sedation. Use Caution/Monitor.

            • clonidine

              brivaracetam and clonidine both increase sedation. Use Caution/Monitor.

            • clorazepate

              brivaracetam and clorazepate both increase sedation. Use Caution/Monitor.

            • clozapine

              brivaracetam and clozapine both increase sedation. Use Caution/Monitor.

            • codeine

              brivaracetam and codeine both increase sedation. Use Caution/Monitor.

            • cyclobenzaprine

              brivaracetam and cyclobenzaprine both increase sedation. Use Caution/Monitor.

            • cyproheptadine

              brivaracetam and cyproheptadine both increase sedation. Use Caution/Monitor.

            • dantrolene

              brivaracetam and dantrolene both increase sedation. Use Caution/Monitor.

            • daridorexant

              brivaracetam and daridorexant both increase sedation. Use Caution/Monitor.

            • desflurane

              brivaracetam and desflurane both increase sedation. Use Caution/Monitor.

            • desipramine

              brivaracetam and desipramine both increase sedation. Use Caution/Monitor.

            • deutetrabenazine

              brivaracetam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dexbrompheniramine

              brivaracetam and dexbrompheniramine both increase sedation. Use Caution/Monitor.

            • dexchlorpheniramine

              brivaracetam and dexchlorpheniramine both increase sedation. Use Caution/Monitor.

            • diazepam

              brivaracetam and diazepam both increase sedation. Use Caution/Monitor.

            • difenoxin hcl

              brivaracetam and difenoxin hcl both increase sedation. Use Caution/Monitor.

            • dimenhydrinate

              brivaracetam and dimenhydrinate both increase sedation. Use Caution/Monitor.

            • diphenhydramine

              brivaracetam and diphenhydramine both increase sedation. Use Caution/Monitor.

            • diphenoxylate hcl

              brivaracetam and diphenoxylate hcl both increase sedation. Use Caution/Monitor.

            • doxepin

              brivaracetam and doxepin both increase sedation. Use Caution/Monitor.

            • doxylamine

              brivaracetam and doxylamine both increase sedation. Use Caution/Monitor.

            • droperidol

              brivaracetam and droperidol both increase sedation. Use Caution/Monitor.

            • efavirenz

              brivaracetam and efavirenz both increase sedation. Use Caution/Monitor.

            • entacapone

              brivaracetam and entacapone both increase sedation. Use Caution/Monitor.

            • esketamine intranasal

              esketamine intranasal, brivaracetam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

            • estazolam

              brivaracetam and estazolam both increase sedation. Use Caution/Monitor.

            • eszopiclone

              brivaracetam and eszopiclone both increase sedation. Use Caution/Monitor.

            • ethanol

              ethanol, brivaracetam. Other (see comment). Use Caution/Monitor. Comment: Coadministration with ethanol may enhance CNS depressant effects (eg, decreases in saccadic peak velocity, smooth pursuit, adaptive tracking performance, and Visual Analog Scale (VAS) alertness).

              brivaracetam and ethanol both increase sedation. Use Caution/Monitor.

            • ethosuximide

              brivaracetam and ethosuximide both increase sedation. Use Caution/Monitor.

            • ethotoin

              brivaracetam and ethotoin both increase sedation. Use Caution/Monitor.

            • felbamate

              brivaracetam and felbamate both increase sedation. Use Caution/Monitor.

            • fenfluramine

              brivaracetam and fenfluramine both increase sedation. Use Caution/Monitor.

            • fexinidazole

              fexinidazole will increase the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

            • fexofenadine

              brivaracetam and fexofenadine both increase sedation. Use Caution/Monitor.

            • flibanserin

              brivaracetam and flibanserin both increase sedation. Use Caution/Monitor.

            • fluphenazine

              brivaracetam and fluphenazine both increase sedation. Use Caution/Monitor.

            • flurazepam

              brivaracetam and flurazepam both increase sedation. Use Caution/Monitor.

            • gabapentin

              brivaracetam and gabapentin both increase sedation. Use Caution/Monitor.

            • ganaxolone

              brivaracetam and ganaxolone both increase sedation. Use Caution/Monitor.

            • guanfacine

              brivaracetam and guanfacine both increase sedation. Use Caution/Monitor.

            • haloperidol

              brivaracetam and haloperidol both increase sedation. Use Caution/Monitor.

            • hydroxyzine

              brivaracetam and hydroxyzine both increase sedation. Use Caution/Monitor.

            • iloperidone

              brivaracetam and iloperidone both increase sedation. Use Caution/Monitor.

            • imipramine

              brivaracetam and imipramine both increase sedation. Use Caution/Monitor.

            • isoflurane

              brivaracetam and isoflurane both increase sedation. Use Caution/Monitor.

            • ketamine

              brivaracetam and ketamine both increase sedation. Use Caution/Monitor.

            • ketotifen, drug-eluting contact lens

              brivaracetam and ketotifen, drug-eluting contact lens both increase sedation. Use Caution/Monitor.

            • lamotrigine

              brivaracetam and lamotrigine both increase sedation. Use Caution/Monitor.

            • lasmiditan

              lasmiditan, brivaracetam. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

            • lemborexant

              lemborexant, brivaracetam. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

            • levetiracetam

              brivaracetam, levetiracetam. Other (see comment). Use Caution/Monitor. Comment: Coadministration provided no added therapeutic benefit and may cause additive/synergistic adverse effects.

              brivaracetam and levetiracetam both increase sedation. Use Caution/Monitor.

            • levocetirizine

              brivaracetam and levocetirizine both increase sedation. Use Caution/Monitor.

            • levorphanol

              brivaracetam and levorphanol both increase sedation. Use Caution/Monitor.

            • loratadine

              brivaracetam and loratadine both increase sedation. Use Caution/Monitor.

            • lorazepam

              brivaracetam and lorazepam both increase sedation. Use Caution/Monitor.

            • loxapine

              brivaracetam and loxapine both increase sedation. Use Caution/Monitor.

            • lumateperone

              brivaracetam and lumateperone both increase sedation. Use Caution/Monitor.

            • lurasidone

              brivaracetam and lurasidone both increase sedation. Use Caution/Monitor.

            • maprotiline

              brivaracetam and maprotiline both increase sedation. Use Caution/Monitor.

            • mavacamten

              brivaracetam will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Inititiation of weak CYP2C19 inhibitors may require decreased mavacamten dose.

            • meclizine

              brivaracetam and meclizine both increase sedation. Use Caution/Monitor.

            • meperidine

              brivaracetam and meperidine both increase sedation. Use Caution/Monitor.

            • meprobamate

              brivaracetam and meprobamate both increase sedation. Use Caution/Monitor.

            • metaxalone

              brivaracetam and metaxalone both increase sedation. Use Caution/Monitor.

            • methocarbamol

              brivaracetam and methocarbamol both increase sedation. Use Caution/Monitor.

            • methohexital

              brivaracetam and methohexital both increase sedation. Use Caution/Monitor.

            • methsuximide

              brivaracetam and methsuximide both increase sedation. Use Caution/Monitor.

            • midazolam

              brivaracetam and midazolam both increase sedation. Use Caution/Monitor.

            • midazolam intranasal

              midazolam intranasal, brivaracetam. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

            • mirtazapine

              brivaracetam and mirtazapine both increase sedation. Use Caution/Monitor.

            • molindone

              brivaracetam and molindone both increase sedation. Use Caution/Monitor.

            • nalbuphine

              brivaracetam and nalbuphine both increase sedation. Use Caution/Monitor.

            • nitrous oxide

              brivaracetam and nitrous oxide both increase sedation. Use Caution/Monitor.

            • nortriptyline

              brivaracetam and nortriptyline both increase sedation. Use Caution/Monitor.

            • olanzapine

              brivaracetam and olanzapine both increase sedation. Use Caution/Monitor.

            • oliceridine

              brivaracetam and oliceridine both increase sedation. Use Caution/Monitor.

            • olopatadine intranasal

              brivaracetam and olopatadine intranasal both increase sedation. Use Caution/Monitor.

            • opicapone

              brivaracetam and opicapone both increase sedation. Use Caution/Monitor.

            • opium tincture

              brivaracetam and opium tincture both increase sedation. Use Caution/Monitor.

            • orphenadrine

              brivaracetam and orphenadrine both increase sedation. Use Caution/Monitor.

            • oxazepam

              brivaracetam and oxazepam both increase sedation. Use Caution/Monitor.

            • paliperidone

              brivaracetam and paliperidone both increase sedation. Use Caution/Monitor.

            • pentazocine

              brivaracetam and pentazocine both increase sedation. Use Caution/Monitor.

            • pentobarbital

              brivaracetam and pentobarbital both increase sedation. Use Caution/Monitor.

            • perampanel

              brivaracetam and perampanel both increase sedation. Use Caution/Monitor.

            • perphenazine

              brivaracetam and perphenazine both increase sedation. Use Caution/Monitor.

            • pheniramine

              brivaracetam and pheniramine both increase sedation. Use Caution/Monitor.

            • phenobarbital

              phenobarbital will decrease the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Brivaracetam plasma concentration decreased by 19%.

              brivaracetam and phenobarbital both increase sedation. Use Caution/Monitor.

            • phenytoin

              phenytoin will decrease the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Brivaracetam plasma concentration decreased by 21%.

              brivaracetam increases levels of phenytoin by decreasing metabolism. Use Caution/Monitor. Up to 20% increase in phenytoin plasma concentrations observed. Monitor phenytoin levels when brivaracetam is coadministered or discontinued from ongoing phenytoin therapy. .

            • pimozide

              brivaracetam and pimozide both increase sedation. Use Caution/Monitor.

            • pomalidomide

              brivaracetam and pomalidomide both increase sedation. Use Caution/Monitor.

            • pregabalin

              brivaracetam and pregabalin both increase sedation. Use Caution/Monitor.

            • primidone

              brivaracetam and primidone both increase sedation. Use Caution/Monitor.

            • prochlorperazine

              brivaracetam and prochlorperazine both increase sedation. Use Caution/Monitor.

            • promethazine

              brivaracetam and promethazine both increase sedation. Use Caution/Monitor.

            • propofol

              brivaracetam and propofol both increase sedation. Use Caution/Monitor.

            • protriptyline

              brivaracetam and protriptyline both increase sedation. Use Caution/Monitor.

            • pyrilamine

              brivaracetam and pyrilamine both increase sedation. Use Caution/Monitor.

            • quazepam

              brivaracetam and quazepam both increase sedation. Use Caution/Monitor.

            • quetiapine

              brivaracetam and quetiapine both increase sedation. Use Caution/Monitor.

            • ramelteon

              brivaracetam and ramelteon both increase sedation. Use Caution/Monitor.

            • remimazolam

              brivaracetam and remimazolam both increase sedation. Use Caution/Monitor.

            • reserpine

              brivaracetam and reserpine both increase sedation. Use Caution/Monitor.

            • rifampin

              rifampin will decrease the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. The dose of brivaracetam should be increased up to 100% (ie, double the dosage) in patients while receiving concomitant treatment with rifampin.

            • risperidone

              brivaracetam and risperidone both increase sedation. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP2C19 substrates, if clinically indicated.

            • scopolamine

              brivaracetam and scopolamine both increase sedation. Use Caution/Monitor.

            • sevoflurane

              brivaracetam and sevoflurane both increase sedation. Use Caution/Monitor.

            • sodium oxybate

              brivaracetam and sodium oxybate both increase sedation. Use Caution/Monitor.

            • sparsentan

              sparsentan will decrease the level or effect of brivaracetam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Sparsentan (a CYP2C19 inducer) decreases exposure of CYP2C19 substrates and reduces efficacy related to these substrates.

            • stiripentol

              stiripentol, brivaracetam. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

            • sufentanil

              brivaracetam and sufentanil both increase sedation. Use Caution/Monitor.

            • sufentanil SL

              brivaracetam and sufentanil SL both increase sedation. Use Caution/Monitor.

            • suvorexant

              brivaracetam and suvorexant both increase sedation. Use Caution/Monitor.

            • tapentadol

              brivaracetam and tapentadol both increase sedation. Use Caution/Monitor.

            • tasimelteon

              brivaracetam and tasimelteon both increase sedation. Use Caution/Monitor.

            • temazepam

              brivaracetam and temazepam both increase sedation. Use Caution/Monitor.

            • tetrabenazine

              brivaracetam and tetrabenazine both increase sedation. Use Caution/Monitor.

            • thioridazine

              brivaracetam and thioridazine both increase sedation. Use Caution/Monitor.

            • thiothixene

              brivaracetam and thiothixene both increase sedation. Use Caution/Monitor.

            • tiagabine

              brivaracetam and tiagabine both increase sedation. Use Caution/Monitor.

            • tizanidine

              brivaracetam and tizanidine both increase sedation. Use Caution/Monitor.

            • tolcapone

              brivaracetam and tolcapone both increase sedation. Use Caution/Monitor.

            • topiramate

              brivaracetam and topiramate both increase sedation. Use Caution/Monitor.

            • tramadol

              brivaracetam and tramadol both increase sedation. Use Caution/Monitor.

            • trazodone

              brivaracetam and trazodone both increase sedation. Use Caution/Monitor.

            • triazolam

              brivaracetam and triazolam both increase sedation. Use Caution/Monitor.

            • trifluoperazine

              brivaracetam and trifluoperazine both increase sedation. Use Caution/Monitor.

            • triprolidine

              brivaracetam and triprolidine both increase sedation. Use Caution/Monitor.

            • valproic acid

              brivaracetam and valproic acid both increase sedation. Use Caution/Monitor.

            • vigabatrin

              brivaracetam and vigabatrin both increase sedation. Use Caution/Monitor.

            • zaleplon

              brivaracetam and zaleplon both increase sedation. Use Caution/Monitor.

            • ziconotide

              brivaracetam and ziconotide both increase sedation. Use Caution/Monitor.

            • ziprasidone

              brivaracetam and ziprasidone both increase sedation. Use Caution/Monitor.

            • zolpidem

              brivaracetam and zolpidem both increase sedation. Use Caution/Monitor.

            • zonisamide

              brivaracetam and zonisamide both increase sedation. Use Caution/Monitor.

            Minor (0)

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              Adverse Effects

              >10%

              Somnolence and sedation (16%)

              Dizziness (12%)

              1-10%

              Fatigue (9%)

              Nausea and vomiting (5%)

              Cerebellar coordination and balance disturbances (3%)

              Irritability (3%)

              Constipation (2%)

              Postmarketing Reports

              Dysgeusia, euphoric mood, feeling drunk, infusion site pain, decreased appetite

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              Warnings

              Contraindications

              Hypersensitivity; bronchospasms and angioedema have occurred

              Cautions

              May cause psychiatric adverse reactions, including nonpsychotic and psychotic symptoms; advise patients and caregivers/families to be alert for these behavioral changes and report them to their physician immediately

              Hypersensitivity reactions reported, including bronchospasm and angioedema; if a patient develops hypersensitivity reactions after treatment, the drug should be discontinued

              If discontinued, withdraw drug gradually because of the risk of increased seizure frequency and status epilepticus; if withdrawal is needed because of a serious adverse event, consider rapid discontinuation

              Suicidal Behavior

              • Antiepileptic drugs increase the risk of suicidal behavior and ideation; monitor for the emergence or worsening of depression, unusual changes in mood or behavior, or suicidal thoughts, behavior, or self-harm; advise patients and caregivers/families to be alert for these behavioral changes and report them to their physician immediately
              • Anyone considering prescribing an antiepileptic drug, such as this one, must balance risk of suicidal thoughts or behaviors with risk of untreated illness; epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior
              • Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated

              Drug interactions overview

              • CYP2C19 poor metabolizers and patients using inhibitors of CYP2C19 may require dose reduction
              • Strong CYP2C19 inducers (eg, rifampin) require dose increase (see Dosage Modifications)
              • Coadministration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine; though data did not reveal any safety concerns, if tolerability issues arise when coadministered, consider carbamazepine reducing the dose
              • Because brivaracetam can increase plasma concentrations of phenytoin, monitor phenytoin levels in patients when concomitant brivaracetam is added to or discontinued from ongoing phenytoin therapy
              • No added therapeutic benefit to levetiracetam when the two drugs were coadministered
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              Pregnancy & Lactation

              Pregnancy

              No adequate and well-controlled studies on pregnant women

              Available data from North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage, or other maternal or fetal outcomes associated with use during pregnancy

              Animal data

              • In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures

              Pregnancy Registry

              • Recommend that pregnant patients enroll in the North American Antiepileptic Drug Pregnancy Registry; this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves
              • Information on the registry can also be found at the Web site http://www.aedpregnancyregistry.org/

              Lactation

              Data from published literature indicate that the drug is present in human milk; there is insufficient information on effects on breastfed infant or on milk production

              The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Exact mechanism unknown

              Displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect

              Absorption

              Highly permeable and is rapidly and almost completely absorbed after PO administration

              Peak plasma time: 1 hr (without food); slower absorption with a high-fat meal

              Distribution

              Protein bound: ≤20%

              Vd: 0.5 L/kg

              Metabolism

              Primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid metabolite and is mediated by hepatic and extra-hepatic amidase

              Secondarily metabolized by hydroxylation on the propyl side chain to form the hydroxy metabolite that is mediated primarily by CYP2C19

              An additional hydroxy acid metabolite is created by hydrolysis of the amide moiety on the hydroxy metabolite or hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9)

              The 3 metabolites are not pharmacologically active

              Elimination

              Half-life: 9 hr

              Excretion

              • Urine (>95%); feces (<1%)
              • <10% of the dose is excreted unchanged in the urine
              • 34% of the dose is excreted as the carboxylic acid metabolite in urine

              Pharmacogenomics

              In human subjects possessing genetic variations in CYP2C19, production of the hydroxy metabolite is decreased 2-fold or 10-fold, while the blood level of brivaracetam itself is increased by 22% or 42%, respectively, in individuals with one or both mutated alleles

              CYP2C19 poor metabolizers and patients using inhibitors of CYP2C19 may require dose reduction

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              Administration

              Oral Administration

              May take with or without food

              Tablet

              • Swallow whole; do not chew or crush

              Oral solution

              • Use a calibrated measuring device to measure and deliver the prescribed dose accurately
              • No dilution is necessary
              • May also be administered using an NT-tube or G-tube

              IV Compatibilities

              0.9% NaCl

              Dextrose 5%

              Lactated Ringer injection

              IV Preparation

              Inspect visually for particulate matter and discoloration prior to administration; product with particulate matter or discoloration should not be used

              Vial is for single dose only

              IV Administration

              Can be administered IV without further dilution or may be mixed with diluents (see IV Compatibilities)

              Infuse IV over 2-15 minutes

              Discontinuation

              Avoid abrupt withdrawal in order to minimize the risk of increased seizure frequency and status epilepticus

              Storage

              Oral

              • Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
              • Oral solution: Do not freeze; discard any unused oral solution remaining after 5 months of first opening the bottle

              IV

              • Unopened vials: Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F); do not freeze
              • Diluted solution: Store at room temperature in PVC bag for up to 4 hr
              • Discard any unused portion
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Briviact intravenous
              -
              50 mg/5 mL vial
              Briviact oral
              -
              100 mg tablet
              Briviact oral
              -
              75 mg tablet
              Briviact oral
              -
              50 mg tablet
              Briviact oral
              -
              25 mg tablet
              Briviact oral
              -
              10 mg tablet
              Briviact oral
              -
              10 mg/mL solution

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.