For: Dravet Syndrome
Diacomit (stiripentol) is an anticonvulsant indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. DIACOMIT Capsules
250 mg: size 2, pink, and imprinted with �Diacomit" and �250mg" are supplied as follows:
Bottles of 60 NDC 68418-7939-6
500 mg: size 0, white, and imprinted with �Diacomit" and �500mg" are supplied as follows:
Bottles of 60 NDC 68418-7940-6
Powder for Oral Suspension
250 mg: pale pink fruit flavored powder packaged in packets are supplied as follows:
Cartons of 60 NDC 68418-7941-6
500 mg: pale pink fruit flavored powder packaged in packets are supplied as follows:
Cartons of 60 NDC 68418-7942-6
16.2 Storage and Handling
Store in a dry place at 20�C to 25�C (68�F to 77�F); excursions permitted to 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. Store in original package to protect from light. These highlights do not include all the information needed to use DIACOMIT safely and effectively.
See full prescribing information for DIACOMIT.
DIACOMIT (stiripentol) capsules, for oral use
DIACOMIT (stiripentol) powder, for oral suspension
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. (1)
DOSAGE AND ADMINISTRATION
The dosage of DIACOMIT is 50 mg/kg/day, administered by mouth in 2 or 3 divided doses. (2.2)
Reduce dose or discontinue dose gradually. (2.3)
Capsules must be swallowed whole with a glass of water during a meal. Capsules should not be broken or opened. (2.4)
Powder for suspension should be mixed in a glass of water and should be taken immediately after mixing during a meal. (2.4)
DOSAGE FORMS AND STRENGTHS
Capsule: 250 mg or 500 mg (3)
Powder for Oral Suspension: 250 mg or 500 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Somnolence: Monitor for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants; If somnolence occurs during co-administration with clobazam, consider an initial reduction of clobazam by 25%. (5.1)
Decreased Appetite and Decreased Weight: the weight of patients and the growth rate of pediatric patients should be carefully monitored. (5.2)
Neutropenia and Thrombocytopenia: Blood counts should be obtained prior to starting treatment with DIACOMIT and then every 6 months. (5.3)
Withdrawal: DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. (5.4)
Risks in Patients with Phenylketonuria (PKU): DIACOMIT powder for suspension contains phenylalanine; consider total daily intake before prescribing to patients with PKU. (5.5)
Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behaviors. (5.6)
ADVERSE REACTIONS
Adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, and insomnia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact BIOCODEX at 1-877-356-7787 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
DIACOMIT 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. (7.1)
Substrates of CYP2C8, CYP2C19, P-gp and BCRP may require a dose reduction. (7.1)
Substrates of CYP1A2, CYP2B6 and CYP3A4 may require a dose adjustment. (7.1)
Strong inducers of CYP1A2, CYP3A4 or CYP2C19: Consider dose increase of DIACOMIT (7.2).
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2018