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When epilepsy takes over everyday life for your patients, CHANGE THE STORY with Keppra

Keppra is a broad spectrum AED [1] with comparable efficacy [2] [3] and a favourable tolerability profile compared with commonly used AEDs*

Find out more about Keppra

Efficacious seizure control in adults and children [2,3]

Favourable retention rate vs 1st generation AEDs such as VPA and CBZ [4]

A different mechanism of action [7,8]

A short titration time [1]

Guideline recommendations [9–12]

*Includes 1st generation AEDs such as valproate or carbamazepine, and 2nd generation AEDs such as topiramate.

Keppra: change the story

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Indications 1

As monotherapy

Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.

As adjunctive therapy

  • In the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children from 1 month of age with epilepsy.
  • In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • In the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

 

Succinct safety information 1

  • Contraindication

    Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.

     

  • Warnings and precautions

    • Discontinuation of treatment – withdraw gradually.
    • Renal or hepatic impairment – dose adjustment might be necessary. Patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.
    • Acute kidney injury – has been very rarely associated with acute kidney injury.
    • Blood cell counts – rare cases of decreased blood cell counts. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.
    • Depression and/or suicidal ideation – small increased risk of suicidal thoughts and behaviour – monitor for signs of depression and/or suicidal ideation and behaviours.
    • Abnormal and aggressive behaviours – levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness.
    • Paediatric population – available data in children did not suggest impact on growth and puberty. However, long-term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.

  • Fertility

    No impact on fertility was detected in animal studies. No clinical data available.

  • Women of childbearing potential

    • Specialist advice should be given to women who are of childbearing potential.
    • Treatment with LEV should be reviewed when a woman is planning to become pregnant.
    • Sudden discontinuation should be avoided as this may lead to breakthrough seizures.

  • Pregnancy

    • Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clearly necessary.
    • There are no adequate data available from the use of levetiracetam in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for human is unknown. (Reference: PI)

  • Lactation

    • LEV is excreted in human breast milk. Therefore, breast-feeding is not recommended.
    • However, if LEV treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.

  • Drug interactions

    • Concomitant administration of LEV and methotrexate has been reported to decrease methotrexate clearance. Blood methotrexate and LEV levels should be carefully monitored in patients treated concomitantly with the two drugs.

  • Adverse reactions [1]

    Very common adverse reactions (≥1/10)

    • Somnolence, headache, nasopharyngitis.

    Common adverse reactions (≥1/100 to <1/10)

    • Asthenia/fatigue, dizziness, anorexia, depression, hostility/aggression, anxiety, insomnia, nervousness/irritability,
      convulsion, balance disorder, lethargy, tremor, vertigo, cough, abdominal pain, diarrhoea, dyspepsia, vomiting,
      nausea, rash.

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Prescribing information

Abbreviations

AED: anti-epileptic drug; CBZ: carbamazepine; LEV: levetiracetam; VPA: valproate.

References

  1. Keppra Prescribing Information.
  2. Brodie MJ, et al. Neurology 2007;68:402–408.
  3. Glauser TA, et al. Neurology 2006;66:1654–1660.
  4. Nevitt SJ, et al. Cochrane Database Syst Rev 2017;12:CD01141.
  5. Tomson T, et al. Lancet Neurol 2018;17(6):530–538.
  6. Hernandez-Diaz S, et al. Neurology 2012;78(21):1692–1699.
  7. Sills GJ. Mechanisms of action of antiepileptic drugs. Available at: https://www.epilepsysociety.org.uk/sites/default/files/attachments/Chapter25Sills2015.pdf. Accessed April 2020.
  8. Lyseng-Williamson KA. Drugs 2011;71(4):489–514.
  9. NICE Guidelines (2020 update). Available at: https://www.nice.org.uk/guidance/cg137. Accessed April 2020.
  10. Glauser T, et al. Epilepsia 2013;54(3):551–563.
  11. SIGN 143. Diagnosis and management of epilepsy in adults: May, 2015. Available at: https://www.sign.ac.uk/sign-143-diagnosis-and-management-of-epilepsy-in-adults.html. Accessed April 2020.
  12. Kanner AM, et al. Neurology 2018;91(2):74–81.

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All mentioned products are registered in Saudi Arabia. This page may contain promotional content. For full prescribing information or adverse events reporting, please click on the relevant button in the header or footer of this page

PM-SA-LVT-WCNT-200002 date of preparation: December 2020