Dosing Formulations

Simple 1:1 Dose
Conversion1

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Dosing

A therapeutic dose on day 1 with the simplicity of no required titration1

The recommended starting dose for monotherapy and adjunctive therapy in1:

  • Adult patients (16 years or older) is 50 mg twice daily (100 mg/day)
  • Pediatric patients weighing less than 50 kg is dependent on body weight

When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability.1

Recommended dosage and dose adjustments

Recommended dosing table Recommended dosing table
Recommended dose adjustments table Recommended dose adjustments table

ASM=antiseizure medication.

Formulations

Multiple formulations offer flexible administration1

Simple 1:1 dose conversion

BRIVIACT® oral solution

Oral solution 10 mg/mL:

300-mL bottles
Oral solution has a shelf
life of 5 months after
opening

BRIVIACT® tablets

Tablets*:

60-count bottles
*10-mg tablets are also available.

BRIVIACT® injection solution

Injection solution
50 mg/5 mL:

Single-use vial undiluted
injection or infusion

Products not shown at actual size.

Can be given with or without food

Tablets should be swallowed whole with liquid. They should not be chewed or crushed

No blood level, respiratory, or cardiac monitoring required

No refrigeration
required

Intravenous injection only1

  • BRIVIACT injection may be used when oral administration is temporarily not feasible
  • BRIVIACT injection should be administered intravenously at the same dosage and same
    frequency as BRIVIACT tablets and oral solution

BRIVIACT injection offers rapid administration1

Injection should be administered intravenously over 2 to 15 minutes. Clinical study experience is up to 4 consecutive days of treatment

No dilution required

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Reference: 1. BRIVIACT® (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc.

Indication

BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
  • Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
  • Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.
  • Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
  • Serious Dermatologic Reactions: Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with BRIVIACT. Time to onset of the serious dermatologic reaction ranged from 3 to 45 days after BRIVIACT initiation in reported cases. BRIVIACT should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious dermatologic reaction, use of BRIVIACT should not be resumed and alternative therapy should be considered.
  • Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

DOSING CONSIDERATIONS

  • Dose adjustments are recommended for patients with all stages of hepatic impairment.
  • When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients. Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

BRIVIACT is a Schedule V controlled substance.

Please see full Prescribing Information.