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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Adverse events and product complaint should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard for the UK or www.hpra.ie for Ireland. Adverse events and product complaint should also be reported to Angelini Pharma on (UK) +44 2034889643, (IRE) +353 1 584 4671 or UKIReporting@angelinipharma.com

The NICE guideline on epilepsies in children, young people and adults (NG217) was published in April 2022 and aims to improve diagnosis and treatment for different seizure types and epilepsy syndromes, and reduce the risks for people with epilepsy.1 The NICE guidance is for:1

People should be supported to self-manage their epilepsy and make informed choices by discussing the following:1

  • Triggers that may provoke seizures
  • Medications for epilepsy, the importance of adherence and possible side effects
  • Reducing epilepsy-related risks, including sudden unexpected death in epilepsy (SUDEP)
  • Impact on daily activities, including driving
  • Their epilepsy syndrome or seizure types

NICE recommends that people with epilepsy, and their families and carers, if appropriate, are offered opportunities to discuss issues that concern them including, but not limited to, the following:1

    • Safety issues, including activities that should be adapted or avoided, e.g., showering rather than baths, cooking safely, caring for babies and young children safely, and avoiding working at heights.
    • Safety issues for children and young people, including supervised swimming and water sports, not climbing above their height without supervision.
    • Potential impact on lifestyle and social life and any experiences of social exclusion.
    • Driving, including Driver and Vehicle Licensing Agency (DVLA) regulations in the UK and the Road Safety Authority (RSA) in Ireland.
    • Employment and education, including concerns and rights related to employment and education.

    • Physical and emotional demands of caring for and supporting a person with epilepsy.
    • Information and support for carers, including assessing carers needs.

    • Concerns about the impact of epilepsy and antiseizure medication (ASM) on cognitive function, including memory, attention, concentration, educational attainment and performance in the workplace.

    • Adherence to ASM(s) and how to improve this.
    • Experiences of side effects from medication and coping strategies.
    • Explaining changes to medication.

    • Emotional health and psychological wellbeing, e.g., experience of depression, anxiety or low mood.
    • Neurobehavioural disorders commonly associated with epilepsy, including autism and ADHD.
    • Stigmatisation of epilepsy.

    • Concerns of people with epilepsy and their families and carers about SUDEP.
    • Information about SUDEP, including risk factors and how to reduce the risks.
    • Availability of SUDEP counselling.

Referral to tertiary specialist services

Ensure that all people with suspected or confirmed epilepsy have access to a tertiary epilepsy service, if needed, via their specialist.1 Refer people with epilepsy to a tertiary epilepsy service to be seen within 4 weeks, if any of the following apply:

Non-pharmacological treatments1

  • Ketogenic diet: consider a ketogenic diet under guidance of a tertiary epilepsy specialist, in people with:
    • certain childhood-onset epilepsy syndromes
    • drug-resistant epilepsy if other treatment options have been unsuccessful or are not appropriate
  • Resective epilepsy surgery 
  • Vagus nerve stimulation

Please see the full NICE guidelines for details of non-pharmacological treatments.1

Individualised treatment strategy

Reducing the risk of epilepsy related death including SUDEP

Risk factors

Monitoring and review

Arrange regular (at least annual) monitoring reviews for adults with epilepsy and any of the following:1

  • a learning disability
  • drug-resistant epilepsy
  • a high risk of SUDEP
  • a serious comorbidity, such as complex psychological, cognitive or mental health problems
  • taking ASMs associated with long-term side effects or drug interactions
  • able to get pregnant and are taking valproate▼ or any other high risk teratogenic ASMs (see MHRA safety advice on ASMs in pregnancy)3

See the NICE recommendations for the use of ONTOZRY®4

See the SMC recommendations for the use of ONTOZRY®5

In Ireland, the Irish College of General Practitioners (ICGP) recommends that GPs should refer the patient back to secondary care if any of the following are applicable:2

  • Poor seizure control
  • Poor adherence to ASMs or side effects
  • Any neurological deterioration
  • Further advice required on management e.g; pre-conception care, contraception and fitness to drive
  • Patients who are seizure free and who wish to discuss withdrawal of ASMs

Disclaimer

Whilst the NICE guidance includes children and young people, the information on this page focuses on adults. Please see full NICE guidance for further information.1,4

Footnotes

© NICE 2021 Cenobamate for treating focal onset seizures in epilepsy. Technology appraisal guidance TA753. Available from https://www.nice.org.uk/guidance/ta753. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

© SMC 2022 Advice available from https://www.scottishmedicines.org.uk/medicines-advice/cenobamate-ontozry-full-smc2408. All rights reserved. Subject to Notice of rights. SMC advice is prepared for the National Health Service in Scotland. SMC accepts no responsibility for the use of its content in this product/publication.

Abbreviations

ADHD = attention deficit hyperactivity disorder; ASM = anti-seizure medication; DER = drug-resistant epilepsy; DVLA = Driver and Vehicle Licensing Agency; EEG = electroencephalogram; HCP = healthcare professional; ICGP = Irish College of General Practitioners; MHRA = Medicines and Healthcare products Regulatory Agency; NICE = National Institute for Health and Care Excellence; RSA = Road Safety Authority; SMC = Scottish Medicines Consortium; SUDEP = sudden unexpected death in epilepsy.

 

  1. NICE. Epilepsies in children, young people and adults. NICE guideline 217. 27 April 2022. Available at: https://www.nice.org.uk/guidance/ng217 (last accessed January 2023).
  2. Irish College of General Practitioners (ICGP) Quality and Safety in Practice Committee. Good Practice Points: Epilepsy in Adults. Published 01 July 2020. Available at: https://www.icgp.ie/go/library/catalogue/item/9BC4AC16-93A8-4B9D-A5D8CECFC73DD6A5/ (last accessed January 2023).
  3. Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review. Published 7 January 2021. Available at: https://www.gov.uk/drug-safety-update/antiepileptic-drugs-in-pregnancy-updated-advice-following-comprehensive-safety-review (last accessed January 2023).
  4. NICE. Cenobamate for treating focal onset seizures in epilepsy. Technology appraisal guidance TA753. 15 December 2021. Available at: https://www.nice.org.uk/guidance/ta753 (last accessed January 2023).
  5. SMC Advice: Cenobamate. 7 February 2022. Available at: https://www.scottishmedicines.org.uk/medicines-advice/cenobamate-ontozry-full-smc2408 (last accessed January 2023).

UKxxxxP | July 2023

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