Safety
An Established Safety Profile: As of 2024, No New Safety Signal Reported1,2
In the pivotal trials, adverse events were considered mild to moderate. Many adverse reactions associated with DIACOMIT can be predicted and managed, and most are consistent with class therapy.1
The most common side effects, occurring in 10% or more of patients treated with DIACOMIT and more frequently than placebo, included:1
- Somnolence (67% vs 23%)
- Decreased appetite (45% vs 10%)
- Agitation (27% vs 16%)
- Ataxia (27% vs 23%)
- Decreased weight (27% vs 6%)
- Hypotonia (24% vs 13%)
- Nausea (15% vs 3%)
- Tremor (15% vs 10%)
- Dysarthria (12% vs 0%)
- Insomnia (12% vs 7%)
Managing Common Side Effects With Dose Adjustments
Somnolence and decreased appetite can be managed, or even reversed, with dose adjustments to clobazam and valproate, respectively.1
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
Decreased appetite or weight
Reduce valproate by 30% per week
- Monitor the weight of patients and the growth rate of pediatric patients
References
1. DIACOMIT® [prescribing information]. Beauvais, France: Biocodex, Inc.; July 2022. 2. DIACOMIT Periodic Benefit-Risk Evaluation Reports (PBRERs). Beauvais, France: Biocodex, Inc.; January 2022.