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Brivaracetam oral

Updated 2 Feb 2023 | Other antiepileptics

Presentation

Oral formulations of brivaracetam.

Drugs List

  • brivaracetam 100mg film coated tablets
  • brivaracetam 10mg film coated tablets
  • brivaracetam 25mg film coated tablets
  • brivaracetam 50mg film coated tablets
  • brivaracetam 50mg/5ml oral solution sugar-free
  • brivaracetam 75mg film coated tablets
  • BRIVIACT 100mg film coated tablets
  • BRIVIACT 10mg film coated tablets
  • BRIVIACT 10mg/ml oral solution
  • BRIVIACT 25mg film coated tablets
  • BRIVIACT 50mg film coated tablets
  • BRIVIACT 75mg film coated tablets
  • Therapeutic Indications

    Uses

    Epilepsy-partial seizures with/without secondary generalisation-adjunctive

    Dosage

    The physician should prescribe the most appropriate formulation and strength according to weight and dose.

    Adults

    Initial: 25mg to 50mg twice a day (morning and evening).
    Maintenance: 25mg to 100mg twice a day (morning and evening).

    Children

    Children aged 2 to 18 years weighing 50kg or more:
    Initial: 25mg to 50mg twice a day (morning and evening).
    Maintenance: 25mg to 100mg twice a day (morning and evening). The recommended maintenance dose is 50mg twice a day.

    Children aged 2 to 18 years weighing between 20 and 50kg:
    Initial: 0.5mg/kg to 1mg/kg twice a day (morning and evening).
    Maintenance: 0.5mg/kg to 2mg/kg twice a day (morning and evening). The recommended maintenance dose is 1mg/kg twice a day.

    Children aged 2 to 18 years weighing between 10 and 20kg:
    Initial: 0.5mg/kg to 1.25mg/kg twice a day (morning and evening).
    Maintenance: 0.5mg/kg to 2.5mg/kg twice a day (morning and evening). The recommended maintenance dose is 1.25mg/kg twice a day.

    Patients with Hepatic Impairment

    Adults
    Initial: 25mg twice a day.
    Maintenance: Maximum dose of 75mg twice a day.

    Children aged 2 to 18 years weighing 50kg or more:
    Initial: 25mg twice a day.
    Maintenance: Maximum dose of 75mg twice a day.

    Children aged 2 to 18 years weighing between 20 and 50kg:
    Initial: 0.5mg/kg twice a day.
    Maintenance: Maximum dose of 1.5mg/kg twice a day.

    Children aged 2 to 18 years weighing between 10 and 20kg:
    Initial: 0.5mg/kg twice a day.
    Maintenance: Maximum dose of 2mg/kg twice a day.

    Additional Dosage Information

    Missed dose
    If one or more doses are missed, a single dose should be taken as soon as the patient remembers. The next dose should follow at the usual morning or evening time.

    Discontinuation
    Withdraw by 50mg per day on a weekly basis. After 1 week of treatment at 50mg per day, a final week of treatment at the dose of 20mg per day is recommended.

    Contraindications

    Children under 2 years
    Children weighing less than 10kg
    Breastfeeding
    End stage renal disease
    Renal dialysis

    Precautions and Warnings

    Females of childbearing potential
    Suicidal ideation
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    Lactose intolerance
    Pregnancy

    Reduce dose in patients with hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient not to drive until they know how the medicine affects them
    Oral liquid contains hydroxybenzoate: caution in hypersensitivity
    Oral liquid contains propylene glycol
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain lactose
    Monitor for signs of suicide ideation or behaviour
    Progressive withdrawal recommended
    Advise patient to seek advice at first indications of pregnancy
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    Advise patient/carers to report signs of suicide ideation or behaviour

    Pregnancy and Lactation

    Pregnancy

    Use brivaracetam with caution during pregnancy.

    The manufacturer does not recommend using brivaracetam during pregnancy unless the benefit to the mother clearly outweighs the risk to the foetus. At the time of writing there is limited published information regarding the use of brivaracetam during pregnancy. Potential risks are unknown.

    Women with epilepsy treated during pregnancy have shown a two to three times greater risk of teratogenic effects. However, discontinuing anti-epileptic medication during pregnancy may increase risk of the disease. Evaluate the benefits and risks of continuing anti-epileptic therapy throughout pregnancy.

    Lactation

    Brivaracetam is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues brivaracetam or discontinues breastfeeding. Animal data reports significant levels of brivaracetam in the breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown. LactMed (2020) states treatment with brivaracetam is not a reason to discontinue breastfeeding, however exposed infants should be monitored for drowsiness, agitation and adequate weight gain.

    Side Effects

    Aggression
    Agitation
    Anxiety
    Constipation
    Convulsions
    Cough
    Decreased appetite
    Depression
    Dizziness
    Fatigue
    Hypersensitivity reactions
    Influenza
    Insomnia
    Irritability
    Nausea
    Neutropenia
    Psychomotor hyperactivity
    Psychotic disorder
    Somnolence
    Suicidal tendencies
    Upper respiratory tract infection
    Vertigo
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: April 2021

    Reference Sources

    Summary of Product Characteristics: Briviact film coated tablets. UCB Pharma Limited. Revised November 2020.
    Summary of Product Characteristics: Briviact 10mg/ml oral solution. UCB Pharma Limited. Revised November 2020.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 December 2022

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Brivaracetam Last revised: 21 September 2020
    Last accessed: 07 April 2021

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