Briviact

Drug overview for BRIVIACT (brivaracetam):

Generic name: BRIVARACETAM (BRIV-a-RA-se-tam)
Drug class: Anticonvulsants
Therapeutic class: Central Nervous System Agents

Brivaracetam, a pyrrolidine derivative, is an anticonvulsant.

No enhanced Uses information available for this drug.

DRUG IMAGES

BRIVIACT 10 MG TABLET
BRIVIACT 50 MG TABLET
BRIVIACT 25 MG TABLET
BRIVIACT 75 MG TABLET
BRIVIACT 100 MG TABLET
BRIVIACT 10 MG/ML ORAL SOLN
BRIVIACT 50 MG/5 ML VIAL

The following indications for BRIVIACT (brivaracetam) have been approved by the FDA:

Indications:
Focal epilepsy

Professional Synonyms:
Cortical epilepsy
Focal seizures
Local epilepsy
Partial epilepsy
Partial onset seizures
Partial seizures

The following dosing information is available for BRIVIACT (brivaracetam):

Dosing
Administration
BRIVIACT
Generic

No enhanced Dosing information available for this drug.

Brivaracetam is administered orally (as tablets or oral solution). The drug also may be administered IV when oral administration is temporarily not feasible; the manufacturer states that clinical experience with IV brivaracetam is limited to 4 consecutive days of treatment. Commercially available brivaracetam tablets and oral solution are bioequivalent, and the bioavailability of the tablets is similar to that of the injection formulation.

All dosage forms can be used interchangeably without dosage adjustment. Brivaracetam tablets and oral solution are administered orally twice daily without regard to food. The tablets should be swallowed whole with liquid, and not chewed or crushed.

The oral solution is administered without dilution; if necessary, the solution may be administered through a nasogastric or gastric feeding tube. When using the brivaracetam oral solution, a calibrated measuring device should be used to measure and administer the prescribed dose; a household teaspoon or tablespoon is not an adequate measuring device. Unused portions of the oral solution should be discarded 5 months after the container is first opened.

Brivaracetam injection is administered twice daily by direct (''bolus'') IV injection or infusion over 2-15 minutes; the drug may be administered IV without further dilution or may be diluted with 0.9% sodium chloride, lactated Ringer's, or 5% dextrose injection. Diluted solutions of brivaracetam may be stored for up to 4 hours in polyvinyl chloride (PVC) bags at room temperature.

Brivaracetam injection should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit; the drug should not be administered if discoloration or particulate matter is observed. Commercially available brivaracetam injection contains no preservatives and is intended for single use; any partially used vials should be discarded. When discontinuing therapy, brivaracetam should be withdrawn gradually to minimize the potential for increased seizure frequency and status epilepticus in patients with seizure disorders.

(See Discontinuance of Therapy under Cautions: Warnings/Precautions.) Patients currently receiving or beginning therapy with brivaracetam and/or any other anticonvulsant for any indication should be closely monitored for the emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or any unusual changes in mood or behavior. (See Suicidality Risk under Cautions: Warnings/Precautions.)

Dosing information for BRIVIACT
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
BRIVIACT 10 MG TABLET	Maintenance	Adults take 1 tablet (10 mg) by oral route 2 times per day
BRIVIACT 25 MG TABLET	Maintenance	Adults take 1 tablet (25 mg) by oral route 2 times per day
BRIVIACT 50 MG TABLET	Maintenance	Adults take 1 tablet (50 mg) by oral route 2 times per day
BRIVIACT 75 MG TABLET	Maintenance	Adults take 1 tablet (75 mg) by oral route 2 times per day
BRIVIACT 100 MG TABLET	Maintenance	Adults take 1 tablet (100 mg) by oral route 2 times per day
BRIVIACT 10 MG/ML ORAL SOLN	Maintenance	Adults take 5 milliliters (50 mg) by oral route 2 times per day
BRIVIACT 50 MG/5 ML VIAL	Maintenance	Adults inject 5 milliliters (50 mg) over 2-15 minute(s) by intravenous route 2 times per day

No generic dosing information available.

The following drug interaction information is available for BRIVIACT (brivaracetam):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 5 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Brivaracetam; Lamotrigine; Perampanel/Rifampin; Rifapentine SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Rifampin and rifapentine may induce the metabolism of brivaracetam by CYP2C19(1) and lamotrigine(2,3) and perampanel(4) by CYP3A4. CLINICAL EFFECTS: The concurrent use of rifampin or rifapentine with brivaracetam,(1) lamotrigine,(2,3) or perampanel(4) may result in decreased levels and clinical effectiveness of the anticonvulsant. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving rifampin or rifapentine concurrently with brivaracetam, lamotrigine, or perampanel should be observed for decreased anticonvulsant levels and clinical effectiveness. The dose of the anticonvulsant may need to be adjusted if the rifamycin is added to or removed from therapy. Refer to the current anticonvulsant prescribing information for information on dosage adjustments. DISCUSSION: Concurrent rifampin decreases brivaracetam levels by 45%.(1) A study in 10 healthy subjects examined the effects of rifampin (600 mg daily for five days) on a single dose of lamotrigine (25 mg). Pretreatment with rifampin decreased the lamotrigine area-under-curve (AUC) and half-life (T1/2) by 43.7% and 40.8%, respectively. Lamotrigine clearance over bioavailability increased 98.3%. The amount of lamotrigine excreted as the glucuronide metabolite increased 36%.(2) A study in 10 healthy subjects examining the effects of rifampin (600 mg daily for 5 days) on a single dose of lamotrigine (25 mg) showed that rifampin increased the apparent clearance of lamotrigine by approximately 2-fold and decreased the AUC by 40%.(3) Rifampin and rifapentine are expected to decrease perampanel concentrations.(4)	PRIFTIN, RIFADIN, RIFAMPIN
Lumateperone/CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Lumateperone is a substrate of CYP3A4. Inducers of CYP3A4 may induce the metabolism of lumateperone.(1) CLINICAL EFFECTS: The concurrent administration of a CYP3A4 inducer may decrease the exposure to lumateperone.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of lumateperone states that concurrent use with CYP3A4 inducers should be avoided.(1) DISCUSSION: Coadministration of lumateperone with rifampin, a strong CYP3A4 inducer, resulted in a 98% reduction in area-under-curve (AUC) and a 90% reduction in concentration maximum (Cmax).(1) Strong inducers of CYP3A4 include: apalutamide, barbiturates, carbamazepine, encorafenib, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and St. John's wort.(2,3) Moderate inducers of CYP3A4 include: belzutifan, bosentan, cenobamate, dabrafenib, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, repotrectinib, rifabutin, telotristat, thioridazine, and tovorafenib.(2,3) Weak inducers of CYP3A4 include: amprenavir, armodafinil, bexarotene, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, eslicarbazepine, garlic, genistein, gingko, ginseng, glycyrrhizin, nevirapine, omaveloxolone, oxcarbazepine, pioglitazone, quercetin, rufinamide, sotorasib, sulfinpyrazone, tecovirimat, terbinafine, ticlopidine, troglitazone, vemurafenib, and vinblastine.(2,3)	CAPLYTA
Atogepant/CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Strong, moderate, and weak CYP3A4 inducers may increase the metabolism of atogepant by CYP3A4.(1) CLINICAL EFFECTS: The concurrent use of strong, moderate, or weak CYP3A4 inducers with atogepant may result in decreased levels and clinical effectiveness of atogepant.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of atogepant recommends that patients on concomitant strong, moderate, or weak CYP3A4 inducers receive atogepant 30 mg or 60 mg once daily for prevention of episodic migraines and avoid use of atogepant for prevention of chronic migraines.(1) Patients receiving concurrent therapy with CYP3A4 inducers and atogepant should be observed for decreased clinical effectiveness. DISCUSSION: In a study of healthy subjects, rifampin, a strong CYP3A4 inducer, decreased the area-under-curve (AUC) and maximum concentration (Cmax) of atogepant by 60% and 30%, respectively. Topiramate, a weak CYP3A4 inducer, decreased atogepant AUC and Cmax by 25% and 24%, respectively.(1) Strong CYP3A4 inducers linked to this monograph include: apalutamide, barbiturates, carbamazepine, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and St. John's wort. Moderate CYP3A4 inducers linked to this monograph include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, rifabutin, sotorasib, telotristat, thioridazine and tovorafenib. Weak CYP3A4 inducers linked to this monograph include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, eslicarbazepine, floxacillin, garlic, genistein, ginseng, glycyrrhizin, methylprednisolone, mobocertinib, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, quercetin, relugolix, rufinamide, sarilumab, sulfinpyrazone, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(1,2)	QULIPTA
Erlotinib/CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inducers of CYP3A4 may induce the metabolism of erlotinib.(1) CLINICAL EFFECTS: Concurrent or recent use of a CYP3A4 inducer may result in decreased levels and effectiveness of erlotinib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: Avoid the concurrent use of CYP3A4 inducers in patients receiving therapy with erlotinib. Consider the use of alternative agents with less enzyme induction potential.(1) Consider increasing the dosage of erlotinib by 50 mg increments as tolerated at two week intervals (to a maximum of 450 mg) while closely monitoring the patient. The highest dosage studied with concurrent rifampin is 450 mg. If the dosage of erlotinib is increased, it will need to be decreased when the inducer is discontinued.(1) DISCUSSION: Pretreatment and concurrent therapy with rifampin increased erlotinib clearance by 3-fold and decreased the erlotinib area-under-curve (AUC) by 66% to 80%. This is equivalent to a dose of about 30 mg to 50 mg in NSCLC.(1) In a study, pretreatment with rifampin for 11 days decreased the AUC of a single 450 mg dose of erlotinib to 57.6% of the AUC observed with a single 150 mg dose of erlotinib.(1) In a case report, coadministration of phenytoin (180mg daily) and erlotinib (150mg daily) increased the phenytoin concentration from 8.2mcg/ml to 24.2mcg/ml and decreased the erlotinib concentration 12-fold (from 1.77mcg/ml to 0.15mcg/ml) and increased the erlotinib clearance by 10-fold (from 3.53 L/h to 41.7 L/h).(2) In a study, concurrent use of sorafenib (400 mg twice daily) and erlotinib (150 mg daily) decreased the concentration minimum (Cmin), concentration maximum (Cmax), and AUC of erlotinib.(3) In an animal study, concurrent use of dexamethasone and erlotinib decreased the AUC of erlotinib by 0.6-fold.(4) Strong inducers of CYP3A4 include: barbiturates, encorafenib, enzalutamide, fosphenytoin, ivosidenib, mitotane, phenobarbital, phenytoin, primidone, rifampin, and rifapentine.(5,6) Moderate inducers of CYP3A4 include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, sotorasib, telotristat, thioridazine, and tovorafenib.(5,6) Weak inducers of CYP3A4 include: amprenavir, armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dicloxacillin, echinacea, eslicarbazepine, flucloxacillin, garlic, genistein, ginkgo, ginseng, glycyrrhizin, mobocertinib, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, quercetin, relugolix, rufinamide, sarilumab, sulfinpyrazone, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(5,6)	ERLOTINIB HCL
Zuranolone/CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inducers of CYP3A4 may induce the metabolism of zuranolone.(1) CLINICAL EFFECTS: Concurrent use of a CYP3A4 inducer may result in a loss of zuranolone efficacy.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: Avoid the concurrent use of zuranolone with CYP3A4 inducers.(1) DISCUSSION: Coadministration of zuranolone with rifampin decreased the maximum concentration (Cmax) by 0.31-fold and area-under-curve (AUC) by 0.15-fold.(1) Strong CYP3A4 inducers linked to this monograph include: apalutamide, barbiturates, carbamazepine, encorafenib, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and St. John's wort. Moderate CYP3A4 inducers linked to this monograph include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, rifabutin, sotorasib, telotristat ethyl, thioridazine, and tovorafenib. Weak CYP3A4 inducers linked to this monograph include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, eslicarbazepine, flucloxacillin, garlic, genistein, ginseng, glycyrrhizin, methylprednisolone, mobocertinib, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, quercetin, relugolix, rufinamide, sarilumab, sulfinpyrazone, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(2,3)	ZURZUVAE

There are 3 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Exemestane/Selected Moderate-Weak CYP3A4 Inducers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: CYP3A4 inducers may induce the metabolism of exemestane.(1) CLINICAL EFFECTS: Concurrent use of a CYP3A4 inducer may result in decreased levels and effectiveness of exemestane.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The US manufacturer of exemestane recommends that patients receiving concurrent therapy with a strong CYP3A4 inducer receive 50 mg of exemestane daily after a meal.(1) It may be prudent to consider a dosage increase for patients receiving weaker CYP3A4 inducers. DISCUSSION: In a study in 10 healthy postmenopausal subjects, pretreatment with rifampin (a strong CYP3A4 inducer, 600 mg daily for 14 days) decreased the area-under-curve (AUC) and maximum concentration (Cmax) of a single dose of exemestane (25 mg) by 54% and 41%, respectively.(1) Strong inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 80% or more and include: carbamazepine, enzalutamide, mitotane, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.(1-3) Moderate inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 50-80% and include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, lesinurad, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, rifabutin, sotorasib, telotristat ethyl, thioridazine, and tovorafenib.(2,3) Weak inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 20-50% and include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, elafibranor, enasidenib, eslicarbazepine, floxacillin, garlic, gingko, ginseng, glycyrrhizin, lorlatinib, meropenem-vaborbactam, methylprednisolone, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, quercetin, relugolix, rufinamide, sarilumab, sulfinpyrazone, suzetrigine, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(2,3)	AROMASIN, EXEMESTANE
Ubrogepant/Moderate and Weak CYP3A4 Inducers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Moderate or weak CYP3A4 inducers may induce the metabolism of ubrogepant.(1) CLINICAL EFFECTS: Concurrent use of a moderate or weak CYP3A4 inducer may result in decreased levels and effectiveness of ubrogepant.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer recommends a dosage adjustment of ubrogepant when coadministered with moderate or weak CYP3A4 inducers. Initial dose of ubrogepant should be 100 mg. If a second dose is needed, the dose of ubrogepant should be 100 mg.(1) DISCUSSION: Coadministration of ubrogepant with rifampin, a strong CYP3A4 inducer, resulted in an 80% reduction in ubrogepant exposure. No dedicated drug interaction studies were conducted to assess concomitant use with moderate or weak CYP3A4 inducers. Dose adjustment for concomitant use of ubrogepant with moderate or weak CYP3A4 inducers is recommended based on a conservative prediction of 50% reduction in exposure of ubrogepant.(1) Moderate inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 50-80% and include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pexidartinib, rifabutin, telotristat, thioridazine, and tovorafenib.(2,3) Weak inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 20-50% and include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, dexamethasone, dicloxacillin, echinacea, elafibranor, enasidenib, eslicarbazepine, floxacillin, garlic, genistein, ginseng, glycyrrhizin, meropenem-vaborbactam, methylprednisolone, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, relugolix, repotrectinib, rufinamide, sarilumab, sulfinpyrazone,suzetrigine, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(2,3)	UBRELVY
Tacrolimus/Moderate and Weak CYP3A4 Inducers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Moderate or weak CYP3A4 inducers may accelerate the metabolism of tacrolimus.(1) CLINICAL EFFECTS: Concurrent use of a moderate or weak CYP3A4 inducer may result in decreased levels and effectiveness of tacrolimus.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of tacrolimus recommends monitoring tacrolimus whole blood trough concentrations and adjusting tacrolimus dose if needed. Monitor clinical response closely.(1) DISCUSSION: A 13-year-old cystic fibrosis patient with a history of liver transplant on stable doses of tacrolimus underwent 2 separate courses of nafcillin therapy (a moderate CYP3A4 inducer). During the 1st course of nafcillin, his tacrolimus levels started to fall 3 days after starting nafcillin, became undetectable at day 8, and recovered to therapeutic levels without a change in tacrolimus dose 5 days after discontinuation of nafcillin. During the 2nd course of nafcillin, tacrolimus level became undetectable 4 days after starting nafcillin and recovered 3 days after stopping nafcillin.(2) Moderate inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 50-80% and include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, modafinil, nafcillin, repotrectinib, telotristat, and tovorafenib.(3,4) Weak inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 20-50% and include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, elafibranor, enasidenib, eslicarbazepine, floxacillin, garlic, genistein, ginseng, glycyrrhizin, meropenem-vaborbactam, nevirapine, oritavancin, omaveloxolone, oxcarbazepine, pioglitazone, relugolix, rufinamide, sulfinpyrazone, suzetrigine, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vinblastine, and zanubrutinib.(3,4)	ASTAGRAF XL, ENVARSUS XR, PROGRAF, TACROLIMUS, TACROLIMUS XL

Severe List
Child-pugh class A hepatic impairment
Child-pugh class B hepatic impairment
Child-pugh class C hepatic impairment
Depression
Disease of liver
Suicidal ideation

The following adverse reaction information is available for BRIVIACT (brivaracetam):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in at least 5% of patients with partial-onset seizures receiving brivaracetam in controlled clinical trials and at least 2% more frequently than with placebo include somnolence/sedation, dizziness, fatigue, nausea/vomiting, diarrhea, headache, insomnia, and nasopharyngitis.

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	Drug-induced psychosis

Rare/Very Rare
Accidental fall Angioedema Bronchospastic pulmonary disease Leukopenia Neutropenic disorder Suicidal Suicidal ideation

There are 23 less severe adverse reactions.

More Frequent	Less Frequent
Dizziness Drowsy Fatigue Nausea Sedation Symptoms of anxiety Vomiting	Aggressive behavior Agitation Ataxia Behavioral disorders Constipation Depression Dysgeusia Euphoria Gait abnormality Injection site sequelae Irritability Mood changes Nervousness Nystagmus Vertigo

Rare/Very Rare
Indifference

The following precautions are available for BRIVIACT (brivaracetam):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of brivaracetam have not been established in pediatric patients younger than 16 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category C. (See Users Guide.) The North American Antiepileptic Drug (NAAED) Pregnancy Registry may be contacted at 888-233-2334 (for patients); NAAED registry information also is available on the website http://www.aedpregnancyregistry.org.

Brivaracetam produced developmental toxicity (e.g., decreased fetal weight gain, delayed sexual maturation, long-term neurobehavioral changes) and some evidence of embryolethality when administered orally to pregnant animals at exposure levels higher than those associated with the maximum recommended human dose.

It is not known whether brivaracetam is distributed into human milk; however, the drug is distributed into milk in rats. Because many drugs are distributed into human milk, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Experience with brivaracetam in patients 65 years of age and older is insufficient to establish efficacy in this age group. The manufacturer recommends cautious dosage selection in geriatric patients, taking into consideration the greater frequency of decreased hepatic, renal, and/or cardiac function, and other concomitant medical conditions and drug therapy in this population. In a study evaluating the pharmacokinetics of brivaracetam (200 mg twice daily) in geriatric individuals 65-79 years of age with creatinine clearance of 53-98 mL/minute per 1.73

m2, plasma half-life of the drug was 7.9 hours in individuals 65-75 years of age and 9.3 hours in those over 75 years of age; brivaracetam clearance was slightly lower in these geriatric individuals compared with healthy younger adults.

The following icd codes are available for BRIVIACT (brivaracetam)'s list of indications:

Focal epilepsy
G40.0	Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
G40.00	Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, not intractable
G40.009	Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, not intractable, without status epilepticus
G40.01	Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable
G40.019	Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, without status epilepticus
G40.1	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
G40.10	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, not intractable
G40.109	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, not intractable, without status epilepticus
G40.11	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable
G40.119	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, without status epilepticus
G40.2	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
G40.20	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, not intractable
G40.209	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, not intractable, without status epilepticus
G40.21	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable
G40.219	Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, without status epilepticus
G40.C	Lafora progressive myoclonus epilepsy
G40.C0	Lafora progressive myoclonus epilepsy, not intractable
G40.C01	Lafora progressive myoclonus epilepsy, not intractable, with status epilepticus
G40.C09	Lafora progressive myoclonus epilepsy, not intractable, without status epilepticus
G40.C1	Lafora progressive myoclonus epilepsy, intractable
G40.C11	Lafora progressive myoclonus epilepsy, intractable, with status epilepticus
G40.C19	Lafora progressive myoclonus epilepsy, intractable, without status epilepticus