stiripentol: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
stiripentol: clinical details
Prescribing considerations
- Initiate and supervise through a clinician experienced in Dravet syndrome and epilepsy management.
- Licensed as adjunctive treatment with clobazam and valproate; evidence does not support monotherapy.
- Review concomitant medicines carefully because stiripentol inhibits multiple CYP enzymes and transporters.
- Use in children younger than three years requires individual benefit-risk assessment and close monitoring.
- It is not recommended in hepatic or renal impairment.
- Assess sedation, coordination, appetite, weight and tolerability of concomitant antiseizure medicines.
Contraindications and cautions
- Hypersensitivity to stiripentol or a formulation excipient
- History of psychosis presenting as episodes of delirium
- For the sachet: rare glucose-galactose malabsorption or hereditary fructose intolerance; consider its phenylalanine content in phenylketonuria
Monitoring
- Full blood count before treatment and every six months unless clinically indicated sooner
- Liver function before treatment and every six months unless clinically indicated sooner
- Growth, appetite and weight in children
- Sedation, hypotonia, behaviour and coordination
- Adverse effects and, where appropriate, plasma concentrations of interacting antiseizure medicines
Clinical pharmacology
Stiripentol enhances GABA-A receptor-mediated inhibition and alters GABA handling. It also inhibits CYP2C19, CYP2B6, CYP3A4 and other enzymes or transporters. Pharmacokinetics are nonlinear, plasma-protein binding is extensive, and metabolism is predominantly hepatic.
Formulation and product differences
- Capsules must be swallowed whole and should not be opened.
- Sachet powder is mixed with water and taken immediately with a meal.
- The sachet contains aspartame, glucose and sorbitol; the capsule does not contain these excipients.
- Capsule and sachet exposure profiles differ, so switching should occur under clinical supervision.
stiripentol preparations and strengths
Capsule
Route: Oral
Strengths: 250 mg, 500 mg
Oral suspension
Route: Oral
Strengths: 250 mg, 500 mg
stiripentol interactions
Stiripentol affects several liver enzymes and can substantially alter exposure to other medicines. Check all prescribed, non-prescription and complementary products.
Clobazam
Stiripentol can markedly increase clobazam and norclobazam exposure, increasing drowsiness, reduced muscle tone and other adverse effects.
Carbamazepine, phenytoin and phenobarbital
These should not be used with stiripentol for Dravet syndrome because of clinically important interactions.
Other antiseizure medicines
Levels of medicines including primidone, diazepam, ethosuximide and tiagabine may rise, requiring clinical or concentration monitoring.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.