DIACOMIT® (stiripentol) is an effective, FDA-approved medication that was developed specifically to treat seizures associated with Dravet syndrome. It is indicated for patients 6 months and older (weighing 15 lb or more) taking clobazam. There are no clinical data to support the use of DIACOMIT as a monotherapy.1
In the pivotal STICLO studies, side effects were considered mild or moderate in nature. The most common adverse reactions, occurring in 10% or more of patients treated with DIACOMIT and more frequently than placebo, included:1
Adverse events have been consistent across multiple studies and clinical practice experience.1,5,7,8 Stiripentol was first launched in the European Union in 2007, and as of 2021, no significant safety signal has been reported.40 Across five open-label studies, adverse reactions in pediatric patients with Dravet syndrome who were 6 months to younger than 2 years were similar to those seen in the pivotal studies.
Adjusting the dosage of clobazam and valproate can help manage somnolence and changes in appetite.1
Other dosage changes can be made to minimize risks and interactions with other substances.
Risks | Recommendations |
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Phenylketonuria*
*DIACOMIT for oral suspension contains phenylalanine, but DIACOMIT capsules do not. |
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Decreased DIACOMIT concentrations due to induction-based interactions |
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Effects on other drugs |
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Neutropenia and thrombocytopenia |
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Phenylketonuria* |
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*DIACOMIT for oral suspension contains phenylalanine, but DIACOMIT capsules do not. |
Decreased DIACOMIT concentrations due to induction-based interactions |
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Effects on other drugs |
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Neutropenia and thrombocytopenia |
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These are not all the risks for use of DIACOMIT. Please see the Important Safety Information and full Prescribing Information. To report suspected adverse reactions, contact Biocodex at 866-330-3050 or the Food and Drug Administration at 800-FDA-1088 or www.fda.gov/medwatch.
Review the documented and potential drug interactions with DIACOMIT.