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.
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 monotherapy in Dravet syndrome.1
DIACOMIT may help patients achieve profound seizure reduction so families can celebrate everyday wins.1
In the pivotal STICLO studies, side effects were considered mild or moderate in nature. 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. Many adverse reactions associated with DIACOMIT can be predicted and managed, as most are consistent with class therapy. The most common adverse reactions, occurring in 10% or more of patients treated with DIACOMIT and more frequently than placebo, included:1
Trust in Proven Experience
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
Pediatric epileptologist Dr. Sullivan details his 10-year journey with a patient with Dravet syndrome — and how DIACOMIT has substantially reduced his patient’s seizures.
Adjusting the dosage of clobazam and valproate may help manage, or even reverse, somnolence and changes in appetite.1
There are no known contraindications when combining DIACOMIT with other antiseizure medications. Dose adjustments for other antiseizure medications may be required. Clinical discretion is advised, as individual patient considerations may vary when managing antiseizure medication regimens.
| Risks | Recommendations |
|---|---|
| Phenylketonuria*
*DIACOMIT for oral suspension contains phenylalanine, but DIACOMIT capsules do not. |
|
| Decreased DIACOMIT concentrations due to induction-based interactions |
|
| Effects on other drugs |
|
| Neutropenia and thrombocytopenia |
|
| Phenylketonuria* |
|---|
*DIACOMIT for oral suspension contains phenylalanine, but DIACOMIT capsules do not. |
| Decreased DIACOMIT concentrations due to induction-based interactions |
|
| Effects on other drugs |
|
| Neutropenia and thrombocytopenia |
|
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.
