Brivaracetam parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of brivaracetam.
Drugs List
Therapeutic Indications
Uses
Epilepsy-partial seizures with/without secondary generalisation-adjunctive
Dosage
Initial doses are based on physician's assessment of required seizure reduction versus potential side effects. Dose adjustments are based on individual patient response and tolerability.
There is no experience with twice daily intravenous administration of brivaracetam after 4 days.
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 doses:
If patients missed one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. This may avoid the brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures from occurring.
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.
Switching to different dosage forms:
When switching treatment from oral to intravenous brivaracetam or from intravenous to oral brivaracetam, maintain the same daily dose and frequency of administration.
Administration
For intravenous bolus injection or intravenous infusion only.
Contraindications
Children under 2 years
Children weighing less than 10kg
Breastfeeding
End stage renal disease
Precautions and Warnings
Females of childbearing potential
Patients over 65 years
Restricted sodium intake
Suicidal ideation
Hepatic impairment
Pregnancy
Contains more than 1 mmol (23 mg) sodium per dose
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Monitor for signs of suicide ideation or behaviour
Progressive withdrawal recommended
Advise patient to seek advice at first indications of pregnancy
Only recommended for short term use
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 potential risk to the foetus.
There is limited data of the use of brivaracetam in pregnant women. There is no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats. The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam.
Lactation
Brivaracetam is contraindicated during breastfeeding.
The manufacturer recommends that a decision should be made whether to discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the medicinal product to the mother. It is unknown whether brivaracetam is excreted in human breast milk. Studies in rats have shown excretion of brivaracetam in breast milk.
LactMed (2020) states that if brivaracetam is required by the mother, it is not necessarily reason to discontinue breastfeeding, but monitor the infant for drowsiness, agitation, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Measurements of infant serum levels may help rule out toxicity if there is a concern.
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: December 2020
Reference Sources
Summary of Product Characteristics: Briviact 10 mg/ml solution for injection/infusion. UCB Pharma Limited. Revised November 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 6 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: 14 December 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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