HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciStir safely and effectively. See full prescribing information for LuciStir.

INDICATIONS AND USAGE

LuciStir is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more . There are no clinical data to support the use of LuciStir as monotherapy in Dravet syndrome.

DOSAGE AND ADMINISTRATION

• The dosage of LuciStir is 50 mg/kg/day, administered by mouth in 2 or 3 divided doses, depending on age and weight.

• Capsules must be swallowed whole with a glass of water during a meal. Capsules should not be broken or opened.

• Reduce dose or discontinue dose gradually.

DOSAGE FORMS AND STRENGTHS

Capsules: 250 mg×60 capsules

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Somnolence: Monitor for somnolence, particularly when LuciStir is used concomitantly with other CNS depressants; If somnolence occurs during co-administration with clobazam, consider an initial reduction of clobazam by 25%.

• Decreased Appetite and Decreased Weight: the weight of patients and the growth rate of pediatric patients should be carefully monitored.  

• Neutropenia and Thrombocytopenia: Blood counts should be obtained prior to starting treatment with LuciStir and then every 6 months.

• Withdrawal: LuciStir should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.

• Risks in Patients with Phenylketonuria (PKU): LuciStir for oral suspension contains phenylalanine; consider total daily intake before prescribing to patients with PKU.

• Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behaviors.

ADVERSE REACTIONS

Adverse reactions that occurred in at least 10% of LuciStir-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, and insomnia.

DRUG INTERACTIONS

• LuciStir increases the plasma concentration of clobazam and its metabolite through metabolic inhibition of CYP3A4 and CYP2C19. Consider dose reduction of clobazam in case of adverse reactions.

• Substrates of CYP2C8, CYP2C19, P-gp and BCRP may require a dose reduction.

• Substrates of CYP1A2, CYP2B6 and CYP3A4 may require a dose adjustment.

• Strong inducers of CYP1A2, CYP3A4 or CYP2C19: Consider dose increase of LuciStir.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.