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

Keppra is a broad spectrum AED1  with comparable efficacy2,3  and a favourable tolerability profile compared with commonly used AEDs*

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

Keppra - Pack

Indications1

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 4 years 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.

Keppra concentrate is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible.

 

Succinct safety information1

  • 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.
    • Excipients – 750 mg film-coated tablets contain sunset yellow lake (E110) colouring agent which may cause allergic-type reactions.
  • 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

    • A large amount of postmarketing data on pregnant women exposed to LEV monotherapy do not suggest an increase in the risk for major congenital malformations.
    • Only limited evidence is available on the neurodevelopment of children exposed to LEV monotherapy in utero.
    • Physiological changes of pregnancy may lead to decrease in LEV plasma concentrations. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
  • 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.

Abbreviations

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

References

  1. Keppra Prescribing Information, Version 09, September 2018.
  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.

GSK shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of information provided herein. 
For safety information on GSK products or to report an Adverse Event, please contact the toll free line 
0800 CALL GSK (0800 2255 475) or email aereporting.ng@gsk.com 
Full prescribing information is available on request on www.gskpro.com
Please note that it may take up to 10 days to process your request. If you need further assistance contact 
GSK House, 1 Industrial Avenue llupeju, Lagos or via email at customercare_ph_nigeria@gsk.com
GlaxoSmithKline Pharmaceutical Nigeria Ltd, 1 Industrial Avenue, llupeju, Lagos 234-1-271 1000 
©2020 GSK group of companies or its licensor 
Trade marks are owned by or licensed to the GSK group of companies

Keppra is a registered trademark of the GlaxoSmithKline group of companies

PM-NG-LVT-WCNT-200004 Date of preparation: November 2020.