Expanded Indication for DIACOMIT® (stiripentol)!

Approved for children 6 months and up!

DIACOMIT is the only FDA-approved antiseizure medication specifically for seizures associated with Dravet syndrome in children as young as 6 months. It is indicated for patients weighing 15 pounds or more and taking clobazam.

References

  1. DIACOMIT® [prescribing information]. Beauvais, France: Biocodex, Inc.; July 2022.
  2. Kassaï B, Chiron C, Augier S, et al. Severe myoclonic epilepsy in infancy: a systematic review and a meta-analysis of individual patient data. Epilepsia. 2008;49(2):343-348.
  3. Wheless JW, Fulton SP, Mudigoudar BD. Dravet syndrome: a review of current management. Pediatr Neurol. 2020; 107:28-40.
  4. European Medicines Agency. EPAR – Scientific Discussion: Diacomit. https://www.ema.europa.eu/en/documents/scientific-discussion/diacomit-epar-scientific-discussion_en.pdf. Published 2007. Accessed November 16, 2020.
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  12. Canadian Agency for Drugs and Technologies in Health. Common Drug Review: Clinical Review Report on Diacomit (stiripentol). https://www.cadth.ca/sites/default/files/cdr/clinical/sr0360_diacomit_cl_report.pdf. Accessed November 16, 2020.
  13. Government of Canada. Summary Basis of Decision – Diacomit – Health Canada. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00181. Published February 21, 2013. Accessed November 16, 2020.
  14. Australian Department of Health Therapeutic Goods Administration. Australian Public Assessment Report for Stiripentol. https://www.tga.gov.au/sites/default/files/auspar-stiripentol-191112.pdf. Accessed November 16, 2020.
  15. U.S. Food and Drug Administration. Drug Trial Snapshot: DIACOMIT. https://www.fda.gov/Drugs/InformationOnDrugs/ucm618455.htm. Accessed November 16, 2020.
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IMPORTANT SAFETY INFORMATION

WARNINGS & PRECAUTIONS

SleepinessDIACOMIT can cause sleepiness. Your healthcare provider should monitor you for sleepiness, particularly when DIACOMIT is used with other depressants or clobazam.

Decreased Appetite and WeightDIACOMIT can cause a loss in appetite and weight. Your healthcare provider should monitor your growth and weight carefully.

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