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DOSING

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Recommended dosing schedule1
 LGSDSTSC
First weekStarting dose 5 mg/kg/day
(2.5 mg/kg taken twice daily)
Second weekMaintenance dose 10 mg/kg/day
(5 mg/kg taken twice daily)		10 mg/kg/day
(5 mg/kg taken twice daily)
Further titration as applicable
(incremental steps)		Weekly increments 5 mg/kg/day
(2.5 mg/kg administered twice daily)
Maximal recommended dose20 mg/kg/day
(10 mg/kg taken twice daily)		25 mg/kg/day
(12.5 mg/kg taken twice daily)

Based on individual clinical response and tolerability, dosage titrations should be increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day). Any dose increases above 10 mg/kg/day, to maximum recommended dose, should be made considering individual benefit and risk and with adherence to the full monitoring schedule.1

Discontinuation

If EPIDYOLEX® has to be discontinued, the dose should be decreased gradually. In clinical trials cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days. A slower or faster down-titration may be required, as clinically indicated, at the discretion of the prescriber.1

Response optimisation
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EPIDYOLEX® can be co‑administered with other commonly prescribed ASMs and medicines, with/without dose adjustment1

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Monitoring schedule for patients on EPIDYOLEX®1

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EPIDYOLEX® dosing should be adjusted in special populations1

REFUSJON AV LGS, DS og TSC

EPIDYOLEX® er innført av Beslutningsforum i 2022 (LGS og DS) og i 2023 (TSC) og finansieres av sykehus via H-resept for alle tre indikasjoner:

SAFETY

Adverse events generally occur early in treatment and are consistent across all indications11–14

The most common adverse events (≥10% of patients) associated with EPIDYOLEX® are:1

  • Decreased appetite
  • Somnolence
  • Vomiting
  • Pyrexia
  • Diarrhoea
  • Fatigue
61

Up to 61% of adverse events were reported in the first 2 weeks of titration11–13

39-22

Across indications:11–13

  • Up to 39% of adverse events resolved within 4 weeks
  • Up to 22% of adverse events resolved after 4 weeks to end of study
61

In LGS trials, 60% of ALT/AST elevations resolved without treatment discontinuation, and all elevations resolved by end of treatment11

Long-term tolerability of EPIDYOLEX® in open-label extension has been demonstrated as consistent with results from clinical trials in LGS, DS and TSC1,4–6

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EFFICACY BEYOND SEIZURES

BECOME is a global outcomes survey of caregivers of 498 people with LGS or DS that assessed changes in behaviour, cognition and more with EPIDYOLEX® after ≥3 months of treatment, compared to the month prior to initiation.

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ABOUT THE EFFICACY OF EPIDYOLEX®

EPIDYOLEX® has been assessed in 5 Phase III clinical trials within Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) and Tuberous Sclerosis Complex (TSC) including 938 patients and 3 open-label extension studies.

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We are here to help with any questions or concerns you may have about EPIDYOLEX®. Reach out to us for more information or support.

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ABBREVIATIONS

ALT: alanine transaminase; ASM: anti-seizure medication; AST: aspartate transaminase; CBD: cannabidiol; DS: Dravet syndrome; LGS: Lennox-Gastaut syndrome; OLE: open-label extension; TSC: tuberous sclerosis complex; ULN: upper limit of normal.

* Patients were exposed to EPIDYOLEX® as part of a large clinical trial programme within LGS, DS and TSC.1

# Clobazam currently does not have marketing authorisation in Norway.

  1. Epidyolex® Summary of Product Characteristics. Approved: May 2023.
  2. Raga S, et al. Epileptic Disord. 2021;23(1):40–52.
  3. Marchese F, et al. SN Compr Clin Med. 2021;3:2167–2179.
  4. Patel AD, et al. Epilepsia. 2021;62(9):2228–2239.
  5. Scheffer IE, et al. Epilepsia. 2021;62(10):2505–2517.
  6. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  7. Privitera M, et al. Epilepsia. 2021;62:1130–1140.
  8. Cohen JM, et al. Epilepsia. 2021;62:2218–2227.
  9. Berg A, et al. Epilepsy Research. 2023;107280:0920–1211.
  10. Thiele EA, et al. JAMA Neurol. 2021;78(3):285–292.
  11. Privitera M, et al. Epilepsia. 2021;62(5):1130–1140.
  12. Cohen JM, et al. Epilepsia. 2021;62(9):2218–2227.
  13. Wu JY, et al. Epilepsia. 2022;63(5):1189–1199.
  14. Gunning B, et al. Acta Neurol Scand. 2021;143:154–163.
  15. Nabbout R, et al. Epileptic Discord. 2020;22(S1):23–28.

REFERENCES

  1. Epidyolex® Summary of Product Characteristics. Approved: May 2023.
  2. Raga S, et al. Epileptic Disord. 2021;23(1):40–52.
  3. Marchese F, et al. SN Compr Clin Med. 2021;3:2167–2179.
  4. Patel AD, et al. Epilepsia. 2021;62(9):2228–2239.
  5. Scheffer IE, et al. Epilepsia. 2021;62(10):2505–2517.
  6. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  7. Privitera M, et al. Epilepsia. 2021;62:1130–1140.
  8. Cohen JM, et al. Epilepsia. 2021;62:2218–2227.
  9. Berg A, et al. Epilepsy Research. 2023;107280:0920–1211.
  10. Thiele EA, et al. JAMA Neurol. 2021;78(3):285–292.
  11. Privitera M, et al. Epilepsia. 2021;62(5):1130–1140.
  12. Cohen JM, et al. Epilepsia. 2021;62(9):2218–2227.
  13. Wu JY, et al. Epilepsia. 2022;63(5):1189–1199.
  14. Gunning B, et al. Acta Neurol Scand. 2021;143:154–163.
  15. Nabbout R, et al. Epileptic Discord. 2020;22(S1):23–28.

ABBREVIATIONS

ALT: alanine transaminase; ASM: anti-seizure medication; AST: aspartate transaminase; CBD: cannabidiol; DS: Dravet syndrome; LGS: Lennox-Gastaut syndrome; OLE: open-label extension; TSC: tuberous sclerosis complex; ULN: upper limit of normal.

FOOTNOTES

* Patients were exposed to EPIDYOLEX® as part of a large clinical trial programme within LGS, DS and TSC.1

# Clobazam currently does not have marketing authorisation in Norway.