brivaracetam

Absorption: Rapidly and completely absorbed following oral administration. IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Hepatic and extrahepatic amidase-mediated hydrolysis of the amide moiety to form carboxylic acid metabolite (primary route) and hydroxylation primarily by the CYP2C19 isoenzyme to form the hydroxy metabolite (secondary route) (all metabolites inactive). The CYP2C19 isoenzyme exhibits genetic polymorphism (2% of Whites, 4% of Blacks, and 14% of Asians may be poor metabolizers and may have significantly ↑ brivaracetam concentrations and an ↑ risk of adverse effects). >95% excreted by the kidneys (<10% excreted unchanged).

Half-Life: 9 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1–4hr‡	unknown
IV	unknown	end of infusion	unknown

‡1 hr in fasting state; 4 hr with high-fat meal.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
End-stage renal disease.

Use Cautiously in:

All patients (may ↑ risk of suicidal thoughts/behaviors);
Patients who are known or suspected to be poor CYP2C19 metabolizers (may require dose ↓);
Hepatic impairment (dose ↓ recommended);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children 1 mo (safety and effectiveness not established);
Geri: Dose adjustment may be needed because of renal and hepatic function in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: nystagmus

GI: constipation, nausea, vomiting

Hemat: leukopenia

Local: infusion site pain

Neuro: aggression, agitation, anger, anxiety, apathy, belligerence, depression, dizziness, drowsiness, hallucinations, irritability, mood swings, paranoia, psychosis, restlessness, suicidal thoughts/behavior, tearfulness, vertigo, ataxia, balance disorder, coordination difficulties, dysgeusia, euphoria, fatigue

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING BRONCHOSPASM AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

CYP2C19 inducers including rifampin may ↓ levels and effectiveness; ↑ brivaracetam dose by up to 100%.
Concurrent use with carbamazepine may ↑ levels of carbamazepine-epoxide (active metabolite); consider ↓ dose of carbamazepine if tolerability issues occur.
May ↑ levels of phenytoin.

Route/Dosage ⬆ ⬇

IV route should only be used when oral therapy is not feasible.
PO IV (Adults and Children ≥16 yr): 50 mg twice daily; may titrate down to 25 mg twice daily or up to 100 mg twice daily based on tolerability and effectiveness.
PO IV (Children ≥1 mo and ≥50 kg): 25–50 mg twice daily; may titrate up to 100 mg twice daily based on tolerability and effectiveness.
PO IV (Children ≥1 mo and 20–<50 kg): 0.5-1 mg/kg twice daily; may titrate up to 2 mg/kg twice daily based on tolerability and effectiveness.
PO IV (Children ≥1 mo and 11–<20 kg): 0.5-1.25 mg/kg twice daily; may titrate up to 2.5 mg/kg twice daily based on tolerability and effectiveness.
PO IV (Children ≥1 mo and <11 kg): 0.75-1.5 mg/kg twice daily; may titrate up to 3 mg/kg twice daily based on tolerability and effectiveness.

Hepatic Impairment

PO IV (Adults and Children ≥16 yr): 25 mg twice daily; may titrate up to 75 mg twice daily based on tolerability and effectiveness.

Hepatic Impairment

PO IV (Children ≥1 mo and ≥50 kg): 25 mg twice daily; may titrate up to 75 mg twice daily based on tolerability and effectiveness.

Hepatic Impairment

PO IV (Children ≥1 mo and 20–<50 kg): 0.5 mg/kg twice daily; may titrate up to 1.5 mg/kg twice daily based on tolerability and effectiveness.

Hepatic Impairment

PO IV (Children ≥1 mo and 11–<20 kg): 0.5 mg/kg twice daily; may titrate up to 2 mg/kg twice daily based on tolerability and effectiveness.

Hepatic Impairment

PO IV (Children ≥1 mo and <11 kg): 0.75 mg/kg twice daily; may titrate up to 2.25 mg/kg twice daily based on tolerability and effectiveness.

Availability ⬆ ⬇

(Generic available)

Tablets: 10 mg; 25 mg; 50 mg; 75 mg; 100 mg
Oral solutionraspberry-flavored: 10 mg/mL
Solution for injection: 10 mg/mL

Assessment ⬆ ⬇

Assess mental status (orientation, mood, behavior) before and periodically during therapy. Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
Monitor for signs and symptoms of bronchospasm (wheezing, dyspnea) and angioedema (rash, pruritus, perioral swelling) during therapy. If signs of hypersensitivity occur discontinue brivaracetam.

Lab Test Considerations:

May cause ↓ WBC and neutrophil counts.

Implementation ⬆ ⬇

Do not confuse Briviact with Brilinta.
Initiate therapy with oral or IV administration. IV administration may be used when oral dose is not feasible; administer at same dose and frequency as oral doses.
PO: Administer twice daily without regard to food. DNC: Swallow tablets whole with liquid; do not crush or chew.
- Use a calibrated measuring device for accuracy with oral solution. Dilution is not necessary, May be administered via nasogastric or gastrostomy tube. Oral solution is stable for 5 mo after opening.

IV Administration:

Intermittent Infusion: Diluent: May be administered undiluted or diluted with 0.9% NaCl, LR, or D5W. Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter. Solution is stable for up to 4 hr at room temperature; may be stored in polyvinyl chloride bags.
Rate: Administer over 2–15 min.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take brivaracetam as directed. Decrease dose gradually; do not stop abruptly to minimize risk of increased seizure frequency and status epilepticus. Advise patient to read Medication Guide prior to therapy and with each Rx refill in case of changes.
May cause drowsiness, fatigue, dizziness, and balance problems. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Do not resume driving until physician gives clearance based on control of seizure disorder.
Advise patient and family to notify health care professional if behavioral changes, thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage patients who become pregnant to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or on the web at www.aedpregnancyregistry.org. Enrollment must be done by patients themselves.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased incidence of partial-onset seizures.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Code ⬆

NDC Code

50474- UCB, Inc.
- 50474-370- Briviact
  - 50474-370-66- 1 BOTTLE in 1 CARTON (50474-370-66) > 60 TABLET, FILM COATED in 1 BOTTLE

50474- UCB, Inc.
- 50474-470- Briviact
  - 50474-470-09- 100 BLISTER PACK in 1 CARTON (50474-470-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK

50474- UCB, Inc.
- 50474-470- Briviact
  - 50474-470-14- 1 BLISTER PACK in 1 CARTON (50474-470-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

50474- UCB, Inc.
- 50474-470- Briviact
  - 50474-470-66- 1 BOTTLE in 1 CARTON (50474-470-66) > 60 TABLET, FILM COATED in 1 BOTTLE

50474- UCB, Inc.
- 50474-570- Briviact
  - 50474-570-09- 100 BLISTER PACK in 1 CARTON (50474-570-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK

50474- UCB, Inc.
- 50474-570- Briviact
  - 50474-570-14- 1 BLISTER PACK in 1 CARTON (50474-570-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

50474- UCB, Inc.
- 50474-570- Briviact
  - 50474-570-66- 1 BOTTLE in 1 CARTON (50474-570-66) > 60 TABLET, FILM COATED in 1 BOTTLE

50474- UCB, Inc.
- 50474-670- Briviact
  - 50474-670-66- 1 BOTTLE in 1 CARTON (50474-670-66) > 60 TABLET, FILM COATED in 1 BOTTLE

50474- UCB, Inc.
- 50474-770- Briviact
  - 50474-770-09- 100 BLISTER PACK in 1 CARTON (50474-770-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK

50474- UCB, Inc.
- 50474-770- Briviact
  - 50474-770-14- 1 BLISTER PACK in 1 CARTON (50474-770-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

50474- UCB, Inc.
- 50474-770- Briviact
  - 50474-770-66- 1 BOTTLE in 1 CARTON (50474-770-66) > 60 TABLET, FILM COATED in 1 BOTTLE

50474- UCB, Inc.
- 50474-870- Briviact
  - 50474-870-15- 1 BOTTLE in 1 CARTON (50474-870-15) > 300 mL in 1 BOTTLE

50474- UCB, Inc.
- 50474-970- Briviact
  - 50474-970-75- 10 VIAL, GLASS in 1 CARTON (50474-970-75) > 5 mL in 1 VIAL, GLASS (50474-970-63)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Code ⬆