Safety

DIACOMIT®(stiripentol) is an effective, FDA-approved antiseizure medication developed specifically for seizures associated with Dravet syndrome in patients 6 months and older, weighing 15 lb or more and taking clobazam. There are no clinical data to support the use of DIACOMIT as a monotherapy in Dravet syndrome.1 

Mild to Moderate Adverse Events

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

  • Somnolence (67%)
  • Decreased appetite (45%)
  • Agitation (27%)
  • Ataxia (27%)
  • Decreased weight (27%)
  • Hypotonia (24%)
  • Nausea (15%)
  • Tremor (15%)
  • Dysarthria (12%)
  • Insomnia (12%)

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

Committing to Long-Term Seizure Reduction With DIACOMIT

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.

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Side Effects Management

Adjusting the dosage of clobazam and valproate may help manage, or even reverse, somnolence and changes in appetite.1

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Somnolence
  • Reduce clobazam by 25%. If somnolence persists, further reduce by an additional 25% and adjust dosage of other concomitant anticonvulsant drugs with sedating properties.
  • Assess for central nervous system depressants, including alcohol, which may increase risk.
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Decreased appetite and decreased weight
  • Reduce valproate by 30% per week.
  • Monitor the weight of patients and the growth rate of pediatric patients.

Additional Dosage Considerations1

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.
  • Consider combined daily amount of phenylalanine from DIACOMIT for oral suspension and all other sources.
Decreased DIACOMIT concentrations due to induction-based interactions
  • Avoid concomitant use of strong inducers or adjust doses.
  • These may include CYP1A2, CYP3A4, or CYP2C19 inducers, such as rifampin, phenytoin, phenobarbital, and carbamazepine.
Effects on other drugs
  • Reduce doses of substrates of CYP2C8, CYP2C19, P-gp, and BCPR.
  • These may include diazepam or clopidogrel (CYP2C19), carbamazepine (P-gp), and methotrexate, prazosin, or glyburide (BCRP).
Neutropenia and thrombocytopenia
  • Monitor patients for neutropenia or thrombocytopenia.
  • Hematologic testing should be obtained prior to starting treatment and then every 6 months.
Phenylketonuria*
  • Consider combined daily amount of phenylalanine from DIACOMIT for oral suspension and all other sources.

*DIACOMIT for oral suspension contains phenylalanine, but DIACOMIT capsules do not.
Decreased DIACOMIT concentrations due to induction-based interactions
  • Avoid concomitant use of strong inducers or adjust doses.
  • These may include CYP1A2, CYP3A4, or CYP2C19 inducers, such as rifampin, phenytoin, phenobarbital, and carbamazepine.
Effects on other drugs
  • Reduce doses of substrates of CYP2C8, CYP2C19, P-gp, and BCPR.
  • These may include diazepam or clopidogrel (CYP2C19), carbamazepine (P-gp), and methotrexate, prazosin, or glyburide (BCRP).
Neutropenia and thrombocytopenia
  • Monitor patients for neutropenia or thrombocytopenia.
  • Hematologic testing should be obtained prior to starting treatment and then every 6 months.

 

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.

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS None

WARNINGS & PRECAUTIONSSomnolence DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

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