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Prescribers should monitor patients for somnolence. If somnolence occurs during co-administration with clobazam, consider an initial reduction of clobazam by 25%. If somnolence persists, further clobazam reduction by an additional 25% should be considered, as should adjustment of the dosage of other concomitant anticonvulsant drugs with sedating properties. Prescribers should caution patients against engaging in hazardous activities requiring mental alertness, such as operating dangerous machinery or motor vehicles, until the effect of Stiripentol on mental alertness is known.
Stiripentol can cause decreases in appetite and weight. In controlled studies in patients with Dravet syndrome, the incidence of decreased appetite was 46% in Stiripentol-treated patients,compared to 10% in patients on placebo. The incidence of decreased weight was 27% inStiripentol-treated patients, compared to 6% in patients on placebo. Nausea and vomiting also occurred more frequently in Stiripentol-treated patients. Given the frequency of these adverse reactions, the growth of pediatric patients treated with Stiripentol should be carefully monitored. In some cases, decreasing the dose of concomitant valproate by 30% per week can reduce the decrease in appetite and weight.
Stiripentol can cause a significant decline in platelet count. In controlled studies in patients with Dravet syndrome, there were 31 patients treated with Stiripentol who had both a baseline and end-of-study platelet count. A decrease in platelet count from normal at baseline to less than 150,000/µL during the trial was observed in 13% of these Stiripentol-treated patients, but not in any placebo-treated patients.
Hematologic testing should be obtained prior to starting treatment with Stiripentol, and then every 6 months.
As with most antiepileptic drugs, Stiripentol should generally be withdrawn gradually to minimize the risk of increased seizure frequency and status epilepticus.
In situations where rapid withdrawal of Stiripentol is required (e.g., in the setting of a serious adverse reaction), appropriate monitoring is recommended.
Phenylalanine can be harmful to patients with phenylketonuria (PKU). Stiripentol for oral suspension contains phenylalanine, a component of aspartame. Each 250 mg packet contains 1.40 mg phenylalanine; each 500 mg packet contains 2.80 mg phenylalanine. Before prescribing Stiripentol for oral suspension to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including Stiripentol for oral suspension.
Stiripentol capsules do not contain phenylalanine.
Anyone considering prescribing Stiripentol or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
from FDA，2022.07
