brivaracetam (Rx)

Brand and Other Names:Briviact
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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
  • <4 years: Safety and efficacy not established
  • 4 to <16 years
    • 11 to <20 kg: 0.5-1.25 mg/kg PO BID (1-2.5 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 0.5-2.5 mg/kg PO BID (1-5 mg/kg/day)
    • 20 to <50 kg: 0.5-1 mg/kg PO BID (1-2 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 0.5-2 mg/kg PO BID (1-4 mg/kg/day)
    • ≥50 kg: 25-50 mg PO BID (50-100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO BID (50-200 mg/day)
  • ≥16 years
    • 50 mg PO BID (100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO BID (50-200 mg/day)

Injection

  • Indicated for partial-onset seizures in adolescents ≥16 years with epilepsy
  • Injection may be used for patients when oral administration is temporarily not feasible
  • <16 years: Safety and efficacy not established
  • ≥16 years: 50 mg IV q12hr initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg IV BID (50-200 mg/day)
  • Clinical study experience with injection is limited to 4 consecutive days of treatment

Dosage Modifications

Hepatic impairment

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

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

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Interactions

Interaction Checker

and brivaracetam

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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%)

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            Warnings

            Contraindications

            Hypersensitivity; bronchospasms and angioedema have occurred

            Cautions

            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

            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

            May cause somnolence and fatigue (dose-dependent), dizziness, and disturbance in gait or coordination

            Hypersensitivity reactions reported, including bronchospasm and angioedema

            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

            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 in pregnant women

            In animal studies, brivaracetam produced evidence of developmental toxicity at plasma exposures greater than clinical exposure

            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

            Unknown if distributed in human breast milk

            Studies in rats have shown excretion in milk

            Because many drugs are excreted into human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            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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            Formulary

            FormularyPatient Discounts

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

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            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.