Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What Brivaracetam Oral solution is Brivaracetam Oral solution contains the active substance brivaracetam. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy.
What Brivaracetam Oral solution is used for • Brivaracetam Oral solution is used in adults, adolescents and children from 2 years of age.
• It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation.
• Partial seizures are fits that start by only affecting one side of the brain. These partial seizures can spread and extend to larger areas on both sides of the brain - this is called a ‘secondary generalisation’.
• You have been given this medicine to lower the number of fits (seizures) you have.
• Brivaracetam Oral solution is used together with other medicines for epilepsy.
Do not take Brivaracetam Oral solution if: • you are allergic to brivaracetam, other similar chemical compounds as levetiracetam or piracetam or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before taking Brivaracetam Oral solution.
• you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking brivaracetam.
Serious skin reactions including Stevens-Johnson syndrome have been reported in association with brivaracetam treatment. Stop using brivaracetam and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Warnings and precautions Talk to your doctor or pharmacist before taking Brivaracetam Oral solution if:
• You have thoughts of harming or killing yourself. A small number of people being treated with anti-epileptic medicines such as brivaracetam have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, contact your doctor immediately.
• You have liver problems - your doctor may need to adjust your dose.
Children Brivaracetam Oral solution is not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam Oral solution Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines - this is because your doctor may need to adjust your Brivaracetam Oral solution dose:
• Rifampicin - a medicine used to treat bacterial infections.
• St John’s wort (also known as Hypericum perforatum ) - a herbal medicine used to treat depression and anxiety as well as other conditions.
Brivaracetam Oral solution with alcohol • Combining this medicine with alcohol is not recommended.
• If you drink alcohol while taking Brivaracetam Oral solution the negative effects of alcohol may be increased.
Pregnancy and breast-feeding Fertile women should discuss the use of contraceptives with the doctor.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Brivaracetam Oral solution if you are pregnant, as the effects of brivaracetam on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Brivaracetam Oral solution, as brivaracetam passes into breast milk.
Do not stop treatment without talking to your doctor first. Stopping treatment could increase your seizures and harm your baby.
Driving and using machines • You may feel sleepy, dizzy or tired while taking Brivaracetam Oral solution.
• These effects are more likely at the start of the treatment or after a dose increase.
• Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
Brivaracetam Oral solution contains methyl parahydroxybenzoate, sodium, sorbitol and propylene glycol • Methyl parahydroxybenzoate: May cause allergic reactions (possibly delayed).
• Sodium: This medicine contains less than 1 mmol sodium (23 mg) per millilitre, that is to say essentially ‘sodium free’.
• Sorbitol (a type of sugar): This medicine contains 168 mg sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
• Propylene glycol (E1520): This medicine contains maximum 0.8 mg propylene glycol in each millilitre.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. You will take Brivaracetam Oral solution together with other medicines for epilepsy.
How much to take Your doctor will work out the right daily dose for you. Take the daily dose in two equal divided doses, approximately 12 hours apart.
Adolescents and children weighing 50 kg or more, and adults
• The recommended dose is from 25 mg to 100 mg taken twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.
The table below only shows examples of doses to take and which syringe to use. Your doctor will work out the right dose for you and which syringe to use, depending on your weight.
Dose in ml to be taken twice daily and which syringe to use - for adolescents and children weighing 50 kg or more, and adults:
• Weight • 50 kg or more
• Dose in ml (corresponding to 25 mg) • 2.5ml
• Use the 5ml syringe
• Dose in ml (corresponding to 50 mg) • 5ml
• Use the 5ml syringe
• Dose in ml (corresponding to 75 mg) • 7.5ml
• Use the 10ml syringe
• Dose in ml (corresponding to 100 mg) • 10ml
• Use the 10ml syringe
Adolescents and children weighing from 20 kg to less than 50 kg
• The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.
The table below only shows examples of doses to take and which syringe to use. Your doctor will work out the right dose for you and which syringe to use, depending on your weight.
Dose in ml to be taken twice daily and which syringe to use - for adolescents and children weighing from 20 kg to less than 50 kg:
• Weight • 20kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 1ml
• Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg) • 2ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 3ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 4ml
• 25kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 1.25ml
• Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg) • 2.5ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 3.75ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 5ml
• 30kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 1.5ml
• Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg) • 3ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 4.5ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 6ml*
• 35kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 1.75ml
• Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg) • 3.5ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 5.25ml*
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 7ml*
• 40kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 2ml
• Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg) • 4ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 6ml*
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 8ml*
• 45kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 2.25ml
• Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg) • 4.5ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 6.75ml*
• Dose in ml (corresponding to 2 mg/ kg = 025 ml/kg) • 9ml*
For volume between 0.5 ml and 5 ml, use the 5 ml oral syringe
* For volume above 5 ml and up to 10 ml, use the 10 ml oral syringe
Children weighing from 10 kg to less than 20 kg
• The recommended dose is from 0.5 mg to 2.5 mg for each kg of bodyweight, taken twice a day. Your child’s doctor may then decide to adjust your child’s dose to find the best dose for your child.
The table below only shows examples of doses to take and which syringe to use. Your doctor will work out the right dose for you and which syringe to use, depending on your weight.
Dose in ml to be taken twice daily and which syringe to use - for children weighing from 10 kg to less than 20 kg:
• Weight • 10kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 0.5ml
• Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg) • 1.25ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 1.5ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 2ml
• Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg) • 2.5ml
• 12kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 0.6ml
• Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg) • 1.5ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 1.8ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 2.4ml
• Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg) • 3ml
• 14kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 0.7ml
• Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg) • 1.75ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 2.1ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 2.8ml
• Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg) • 3.5ml
• 15kg • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg) • 0.75ml
• Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg) • 1.9ml
• Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg) • 2.25ml
• Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg) • 3ml
• Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg) • 3.75ml
Use the 5 ml syringe
People with liver problems
If you have problems with your liver:
• As an adolescent or child weighing 50 kg or more, or as an adult, the maximum dose you will take is 75 mg twice a day.
• As an adolescent or child weighing from 20 kg to less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
• As a child weighing from 10 kg to less than 20 kg, the maximum dose your child will take is 2 mg for each kg of bodyweight twice a day.
How to take Brivaracetam Oral solution • You can take Brivaracetam Oral solution on its own, or dilute it in water or orange juice shortly before swallowing.
• The medicine may be taken with or without food.
• A nasogastric tube may be used when administering brivaracetam oral solution. The NG tubes are Polyvinylchloride (PVC), 8 French, 121 cm length, with a flush volume of 5mL.
Instructions for use for patients or carers: Two oral syringes will be provided in the carton. Check with your doctor which one you should use.
• For volume between 0.5 ml and 5 ml, you should use the 5 ml oral syringe provided in the carton to ensure accurate dosing.
• For volume above 5 ml and up to 10 ml, you should use the 10 ml oral syringe provided in the carton to ensure accurate dosing.
• Open the bottle: press the cap and turn it anti-clockwise
Follow these steps the first time you take Brivaracetam Oral solution:
• Take off the adaptor from the oral syringe
• Put the adaptor into the top of the bottle
Make sure it is fixed well in place. You do not need to remove the adaptor after use.
Follow these steps each time you take Brivaracetam Oral solution:
• Put the oral syringe into the adaptor opening.
• Turn the bottle upside down.
• Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
• Pull the plunger down to fill the oral syringe with a small amount of solution.
• Then push the plunger up to remove any possible air bubbles.
• Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor.
The plunger may rise back up the barrel on the first dosage. Therefore, ensure that the plunger is kept in position until the oral syringe is disconnected from the bottle.
• Turn the bottle the right way up (figure 9).
• Take the oral syringe out of the adaptor (figure 10).
There are two ways in which you can choose to drink the medicine:
• empty the contents of the syringe into water (or orange juice) by pushing the plunger to the bottom of the oral syringe (figure 11) - you will then need to drink all of the water (add just enough to make it easy to drink) or
• drink the solution directly from the oral syringe without water - drink the whole contents of the syringe (figure 12).
• Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
• To clean the oral syringe, rinse with cold water only, moving the plunger several times up and down to take up and expel the water, without separating the two components of the syringe (figure 13).
Keep the bottle, the oral syringe, and the leaflet in the carton.
How long to take Brivaracetam Oral solution for Brivaracetam Oral solution is a long term treatment – keep taking Brivaracetam Oral solution until your doctor tells you to stop.
If you take more Brivaracetam Oral solution than you should If you have taken more Brivaracetam Oral solution than you should, talk to your doctor. You may feel dizzy and sleepy.
You may also have any of the following symptoms: feeling sick, a feeling of ‘spinning’, problems of keeping your balance, anxiety, feeling very tired, irritability, being aggressive, not being able to sleep, depression, thoughts or attempts of harming or killing yourself.
If you forget to take Brivaracetam Oral solution • If you miss a dose take it as soon as you remember.
• Then take your next dose at the time you would normally take it.
• Do not take a double dose to make up for a forgotten dose.
• If you are not sure what to do, ask your doctor or pharmacist.
If you stop taking Brivaracetam Oral solution • Do not stop taking this medicine unless your doctor tells you to. This is because stopping treatment could increase the number of fits you have.
• If your doctor asks you to stop taking this medicine they will lower your dose gradually. This helps to stop your fits coming back or getting worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people
• feeling sleepy or dizzy
Common: may affect up to 1 in 10 people
• flu
• feeling very tired (fatigue)
• convulsion, a feeling of ‘spinning’ (vertigo)
• feeling and being sick, constipation
• depression, anxiety, not being able to sleep (insomnia), irritability
• infections of the nose and throat (such as the ‘common cold’), cough
• decreased appetite
Uncommon: may affect up to 1 in 100 people
• allergic reactions
• abnormal thinking and/or loss of touch with reality (psychotic disorder), being aggressive, nervous excitement (agitation)
• thoughts or attempts of harming or killing yourself: tell your doctor straight away
• a decrease in white blood cells (called ‘neutropenia’) - shown in blood tests
Not Known: frequency cannot be estimated from the available data
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
Additional side effects in children Common: may affect up to 1 in 10 people
• restlessness and hyperactivity (psychomotor hyperactivity)
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . By reporting side effects you can help provide more information on the safety of this medicine.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• After first opening of the bottle, use within 10 months.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Brivaracetam Oral solution contains The active substance is brivaracetam.
Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
The other ingredients are sorbitol (as sorbitol liquid, non-crystallising), glycerol, carmellose sodium, methyl parahydroxybenzoate, sodium citrate, sucralose, raspberry flavour (propylene glycol (E1520) ~ 81%, triacetin (E1518) ~ 1.3%), citric acid, purified water.
What Brivaracetam Oral solution looks like and contents of the pack Brivaracetam Oral solution is slightly viscous, clear colourless solution.
Brivaracetam Oral solution is filled in an amber glass bottle or an amber PET bottle capped with a child resistant closure (polypropylene, polyethylene) packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe (polypropylene, polyethylene) and polyethylene adaptor for the syringes. Each bottle contains 300 ml of oral solution.
Marketing Authorisation Holder Celix Pharma Ltd.
12 Constance Street
London
E16 2DQ
United Kingdom
Manufacturer Site 1:
LABOMED PHARMACEUTICAL COMPANY S.A.
84 Ioannou Metaxa str.
Koropi
Attica
19441
Greece
Site 2:
IASIS PHARMACEUTICALS HELLAS S.A. – KOROPI
Archimidous street
Koropi Attikis
19400
Greece
Site 3:
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara
123 51
Greece
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected]
This leaflet was last revised in May 2026
Celix Pharma Ltd
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Brivaracetam 10 mg/ml Oral solution comes as solution containing 10 mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Brivaracetam 10 mg/ml Oral solution is brivaracetam.
Medicines with the same active substance include: Brivaracetam Cipla 100 mg Tablet film-coated, Brivaracetam Cipla 25 mg Tablet film-coated, Brivaracetam Cipla 50 mg Tablet film-coated, Brivaracetam Cipla 75 mg Tablet film-coated, Briviact 10 mg Film-coated Tablets, Briviact 10 mg/ml oral solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Brivaracetam 10 mg/ml Oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Brivaracetam Celix Oral solution is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.
Posology
The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and care giver to administer Brivaracetam Celix Oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box.
The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table. The dose should be administered in two equally divided doses, approximately 12 hours apart.
| Recommended starting dose | Recommended maintenance dose | Therapeutic dose range* |
| Adolescents and children weighing 50 kg or more, and adults | ||
| 50 mg/day (or 100 mg/day)** | 100 mg/day | 50 - 200 mg/day |
| Adolescents and children weighing from 20 kg to less than 50 kg | ||
| 1 mg/kg/day (up to 2 mg/kg/day)** | 2 mg/kg/day | 1 – 4 mg/kg/day |
| Children weighing from 10 kg to less than 20 kg | ||
| 1 mg/kg/day (up to 2.5 mg/kg/day)** | 2.5 mg/kg/day | 1 – 5 mg/kg/day |
* Based on individual patient response, the dose may be adjusted within this effective dose range.
** Based on physician's assessment of need for seizure control
Adults
The recommended starting dose is either 50 mg/day or 100 mg/day based on physician's assessment of required seizure reduction versus potential side effects. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.
Adolescents and children weighing 50 kg or more
The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.
Adolescents and children weighing from 20 kg to less than 50 kg
The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician's assessment of need for seizure control.
The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day.
Children weighing from 10 kg to less than 20 kg
The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day.
Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day.
The dose per intake for each patient should be calculated using the following formula:
Volume per administration (ml) = [weight (kg) × daily dose (mg/kg/day)] × 0.05
Brivaracetam Celix Oral solution is provided with:
- a 5 ml syringe graduated every 0.1 ml increments (each 0.1 ml increment corresponds to 1 mg of brivaracetam). Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
- a 10 ml syringe graduated in 0.25 ml increments (each 0.25 ml increment corresponds to 2.5 mg of brivaracetam).
The physician should instruct the patient on the appropriate syringe to use.
If the calculated dose per intake is 5 mg (0.5 ml) or more and up to 50 mg (5 ml), the 5 ml oral syringe should be used.
If the calculated dose per intake is more than 50 mg (5 ml), the larger 10 ml oral syringe should be used.
The calculated dose should be rounded to the nearest graduated increment. If the calculated dose is equidistant between two graduated increments, the larger graduated increment should be used.
The table below provides examples of volumes of oral solution per intake depending on prescribed dose and body weight. The precise volume of oral solution is to be calculated according to the exact body weight of the child. Note that the dosage is limited to the available graduations of the syringes. For example, for a patient that needs a dose of 2.15 ml, the applied volume needs to be rounded up to 2.2 ml as the 5 ml syringe can only deliver 2.1 ml or 2.2 ml. Likewise a volume of 1.13 ml would need to be rounded down to a delivered volume of 1.1 ml.
| Volumes of oral solution to be taken per administration for adolescents and children weighing 50 kg or more, and adults | ||||
| Prescribed dose | For a dose of 50 mg/day 25 mg/intake | For a dose of 100 mg/day 50 mg/intake | For a dose of 150 mg/day 75 mg/intake | For a dose of 200 mg/day 100 mg/intake |
| Recommended syringe | 5 ml | 10 ml | ||
| Weight | Volume administered | Volume administered | ||
| 50 kg or more | 2.5 ml (25 mg) | 5 ml (50 mg) | 7.5 ml (75 mg) | 10 ml (100 mg) |
| Volumes of oral solution to be taken per administration for adolescents and children weighing from 20 kg to less than 50 kg | ||||
| Prescribed dose | For a dose of 1 mg/kg/day 0.05 ml/kg/intake (corresponding to 0.5 mg/kg/intake) | For a dose of 2 mg/kg/day 0.1 ml/kg/intake (corresponding to 1 mg/kg/intake) | For a dose of 3 mg/kg/day 0.15 ml/kg/intake (corresponding to 1.5 mg/kg/intake) | For a dose of 4 mg/kg/day 0.2 ml/kg/intake (corresponding to 2 mg/kg/intake) |
| Recommended syringe | 5 ml | 5 ml or 10 ml* | ||
| Weight | Volume administered | Volume administered | ||
| 20 kg | 1 ml (10 mg) | 2 ml (20 mg) | 3 ml (30 mg) | 4 ml (40 mg) |
| 25 kg | 1.25 ml (12.5 mg) | 2.5 ml (25 mg) | 3.75 ml (37.5 mg) | 5 ml (50 mg) |
| 30 kg | 1.5 ml (15 mg) | 3 ml (30 mg) | 4.5 ml (45 mg) | 6 ml* (60 mg) |
| 35 kg | 1.75 ml (17.5 mg) | 3.5 ml (35 mg) | 5.25 ml* (52.5 mg) | 7 ml* (70 mg) |
| 40 kg | 2 ml (20 mg) | 4 ml (40 mg) | 6 ml* (60 mg) | 8 ml* (80 mg) |
| 45 kg | 2.25 ml (22.5 mg) | 4.5 ml (45mg) | 6.75 ml* (67.5 mg) | 9 ml* (90 mg) |
| * For volume above 5 ml and up to 10 ml, the patient should be instructed to use the 10 ml oral syringe | ||||
| Volumes of oral solution to be taken per administration for children weighing from 10 kg to less than 20 kg | |||||
| Prescribed dose | For a dose of 1 mg/kg/day 0.05 ml/kg/intake (corresponding to 0.5 mg/kg/intake) | For a dose of 2.5 mg/kg/day 0.125 ml/kg/intake (corresponding to 1.25 mg/kg/intake) | For a dose of 3 mg/kg/day 0.15 ml/kg/intake (corresponding to 1.5 mg/kg/intake) | For a dose of 4 mg/kg/day 0.2 ml/kg/intake (corresponding to 2 mg/kg/intake) | For a dose of 5 mg/kg/day 0.25 ml/kg/intake (corresponding to 2.5 mg/kg/intake) |
| Recommended syringe: 5 ml | |||||
| Weight | Volume administered | ||||
| 10 kg | 0.5 ml (5 mg) | 1.25 ml (12.5 mg) | 1.5 ml (15 mg) | 2 ml (20 mg) | 2.5 ml (25 mg) |
| 12 kg | 0.6 ml (6 mg) | 1.5 ml (15 mg) | 1.8 ml (18 mg) | 2.4 ml (24 mg) | 3.0 ml (30 mg) |
| 14 kg | 0.7 ml (7 mg) | 1.75 ml (17.5 mg) | 2.1 ml (21 mg) | 2.8 ml (28 mg) | 3.5 ml (35 mg) |
| 15 kg | 0.75 ml (7.5 mg) | 1.9 ml (19.0 mg) | 2.25 ml (22.5 mg) | 3 ml (30 mg) | 3.75 ml (37.5 mg) |
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
For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis.
For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached.
After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
Special populations
Elderly (65 years of age and above)
No dose adjustment is needed in elderly patients (see section 5.2).
The clinical experience in patients ≥ 65 years is limited.
Renal impairment
No dose adjustment is needed in patients with impaired renal function (see section 5.2). Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function. No clinical data are available in paediatric patients with renal impairment.
Hepatic impairment
Exposure to brivaracetam was increased in adult patients with chronic liver disease.
In patients with hepatic impairment, the following adjusted doses, administered in 2 divided doses, approximately 12 hours apart, are recommended for all stages of hepatic impairment (see sections 4.4 and 5.2).
No clinical data are available in paediatric patients with hepatic impairment.
| Age and body weight | Recommended starting dose | Recommended maximum daily dose |
| Adolescents and children weighing 50 kg or more, and adults | 50 mg/day | 150 mg/day |
| Adolescents and children weighing from 20 kg to less than 50 kg | 1 mg/kg/day | 3 mg/kg/day |
| Children weighing from 10 kg to less than 20 kg | 1 mg/kg/day | 4 mg/kg/day |
Paediatric patients less than 2 years of age
The efficacy of brivaracetam in paediatric patients aged less than 2 years has not yet been established.
Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Method of administration
Brivaracetam Celix Oral solution can be diluted in water or orange juice shortly before swallowing and may be taken with or without food (see section 5.2). A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Brivaracetam Celix Oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Instructions for use are provided in the package leaflet.
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Formal interaction studies have only been performed in adults.
Pharmacodynamic interactions
Concomitant treatment with levetiracetam
In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently. No additional safety or tolerability concern was observed (see section 5.1).
Interaction with alcohol
In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic interaction, but brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory. Intake of brivaracetam with alcohol is not recommended.
Pharmacokinetic interactions
Effects of other medicinal products on the pharmacokinetics of brivaracetam
In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway of brivaracetam is by CYP-independent hydrolysis. A second disposition pathway involves hydroxylation mediated by CYP2C19 (see section 5.2).
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.
Rifampicin
In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45 %. Prescribers should consider adjusting the brivaracetam dose in patients starting or ending treatment with rifampicin.
Strong enzyme inducing AEDs
Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
Other enzyme inducers
Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam. Therefore, starting or ending treatment with St John's wort should be done with caution.
Effects of brivaracetam on other medicinal products
Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered to be low.
In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19. Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam). When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6. No CYP3A4 induction was found in vivo (see midazolam above). CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro, interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3. In vitro, brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
Brivaracetam 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3.
Antiepileptic drugs
Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a population pharmacokinetic analysis of placebo-controlled phase 2-3 clinical studies, and in dedicated drug-drug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate). The effect of the interactions on the plasma concentration is summarised in table 1 (increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time curve as “AUC”, maximum observed concentration as Cmax).
Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs
| AED coadministered | Influence of AED on brivaracetam plasma concentration | Influence of brivaracetam on AED plasma concentration |
| Carbamazepine | AUC 29 % ↓ Cmax 13 % ↓ No dose adjustment required | Carbamazepine - None Carbamazepine-epoxide ↑ (See below) No dose adjustment required. |
| Clobazam | No data available | None |
| Clonazepam | No data available | None |
| Lacosamide | No data available | None |
| Lamotrigine | None | None |
| Levetiracetam | None | None |
| Oxcarbazepine | None | None (monohydroxy derivative, MHD) |
| Phenobarbital | AUC 19 % ↓ No dose adjustment required | None |
| Phenytoin | AUC 21 % ↓ No dose adjustment required | None a AUC 20% ↑ a Cmax 20% ↑ |
| Pregabalin | No data available | None |
| Topiramate | None | None |
| Valproic acid | None | None |
| Zonisamide | No data available | None |
a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam
Carbamazepine
Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine. In controlled clinical studies, the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively. No safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.
Oral contraceptives
Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg), a reduction in oestrogen and progestin AUCs of 27 % and 23 %, respectively, was observed without impact on suppression of ovulation. There was generally no change in the concentration-time profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG).
Women of childbearing potential
Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy).
If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated.
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general
For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population. In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated. Discontinuation of anti-epileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Risk related to brivaracetam
There is a limited amount of data from 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 (see section 5.3). The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide (see section 4.5). There is insufficient data to determine the clinical significance of this effect in pregnancy.
As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Breast-feeding
Brivaracetam is excreted in human breast milk. 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. In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase. There is insufficient data to determine the clinical significance.
Fertility
No human data on the effect of brivaracetam on fertility are available. In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Brivaracetam has minor or moderate influence on the ability to drive and use machines.
Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.
Symptoms
There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the post-marketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions.
Management of overdose
There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since less than 10 % of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
Ask anything about Brivaracetam 10 mg/ml Oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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