Briviact

— THERAPEUTIC CATEGORIES —
  • Seizure disorders

Briviact Generic Name & Formulations

General Description

Brivaracetam 10mg, 25mg, 50mg, 75mg, 100mg; tabs.

Pharmacological Class

Antiepileptic.

How Supplied

Tabs—60; Oral soln—300mL; Single-dose vials—10

Manufacturer

Generic Availability

NO

Mechanism of Action

The precise mechanism by which Briviact exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

Briviact Indications

Indications

Partial-onset seizures, as monotherapy or adjunctive treatment.

Briviact Dosage and Administration

Adult

Interchangeable with other forms. Tabs: swallow whole with liquid. Oral soln: use calibrated measuring device. May also give via nasogastric or gastrostomy tube. IV: administer over 2–15mins; limit to 4 consecutive days of treatment. All: adjust dosage based on response and tolerability. ≥16yrs: initially 50mg twice daily; usual maintenance: 25–100mg twice daily. Hepatic impairment: initially 25mg twice daily; max 75mg twice daily. Concomitant rifampin: double brivaracetam dosage.

Children

<1 month: not established. Interchangeable with other forms. Tabs: swallow whole with liquid. Oral soln: use calibrated measuring device. May also give via nasogastric or gastrostomy tube. IV: administer over 2–15mins; limit to 4 consecutive days of treatment. All: adjust dosage based on response and tolerability. 1 month–<16yrs (<11kg): initially 0.75–1.5mg/kg twice daily; usual maintenance: 0.75–3mg/kg twice daily; (11–<20kg): initially 0.5–1.25mg/kg twice daily; usual maintenance: 0.5–2.5mg/kg twice daily; (20–<50kg): initially 0.5–1mg/kg twice daily; usual maintenance: 0.5–2mg/kg twice daily; (≥50kg): initially 25–50mg twice daily; usual maintenance: 25–100mg twice daily. Hepatic impairment (<11kg): initially 0.75mg/kg twice daily; max 2.25mg/kg twice daily; (11–<50kg): initially 0.5mg/kg twice daily; max 2mg/kg twice daily (11–<20kg) or 1.5mg/kg twice daily (20–<50kg); (≥50kg): as Adult. Concomitant rifampin: double brivaracetam dosage.

Briviact Contraindications

Not Applicable

Briviact Boxed Warnings

Not Applicable

Briviact Warnings/Precautions

Warnings/Precautions

Increased risk of suicidal behavior or ideation; monitor for clinical worsening and/or any unusual changes. Monitor for neurological and psychiatric adverse reactions. Discontinue if hypersensitivity reactions occur. Hepatic impairment: adjust dose (see Adult, Children). End-stage renal disease undergoing dialysis: not recommended. Avoid abrupt cessation. Pregnancy. Nursing mothers.

Briviact Pharmacokinetics

Absorption

  • Median Tmax for tablets taken without food: 1 hour (range 0.25 to 3 hours).

  • When a 50 mg tablet was taken with a high-fat meal, Cmax was decreased by 37% and Tmax was delayed by 3 hours, but AUC was unchanged.

Distribution

  • Weakly bound to plasma proteins ≤20%.

  • Volume of distribution: 0.5 L/kg.

Metabolism

  • Hepatic, extra-hepatic amidase (primarily by hydrolysis, secondarily by CYP2C19 hydroxylation).

Elimination

  • Renal (>95%), fecal (<1%). Half-life: ~9 hours.

Briviact Interactions

Interactions

Antagonized by rifampin. Concomitant carbamazepine: may consider dose reduction if intolerant. May potentiate phenytoin; monitor phenytoin levels when adding or discontinuing brivaracetam from ongoing therapy. Concomitant levetiracetam: no added benefit.

Briviact Adverse Reactions

Adverse Reactions

Somnolence/sedation, dizziness, fatigue, nausea/vomiting; hematologic abnormalities.

Briviact Clinical Trials

See Literature

Briviact Note

Notes

To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.

Briviact Patient Counseling

See Literature