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Important Safety Information Full Prescribing Information

About DIACOMIT®

DIACOMIT® dosing and administration

DIACOMIT® is available in 250 mg and 500 mg dosages, as either capsules or fruit-flavored powder packets

Capsules

Do not break or open. Swallow whole with a glass of water during a meal.
250 mg: NDC 68418‑7939‑6
500 mg: NDC 68418‑7940‑6

Powder packets

Mix in 100 mL of water and consume immediately during a meal. Ensure all powder has been consumed.
250 mg: NDC 68418‑7941‑6
500 mg: NDC 68418‑7942‑6

The recommended oral dosage of DIACOMIT® is 50 mg/kg/day, divided into 2 or 3 separate doses

  • Maximum recommended total dosage: 3,000 mg/day
Instructions for Use

In the event of a missed dose, DIACOMIT® should be taken as soon as possible. If it is almost time for the next dose, do not take the missed dose. Do not double doses.

Management of patients on DIACOMIT®

Medication considerations
(Incidence: DIACOMIT® vs placebo)
Somnolence
(67% vs 23%)
  • Reduce clobazam by 25%; further reduce by an additional 25% if somnolence persists and adjust dosage of other concomitant anticonvulsant drugs with sedating properties
  • Central nervous system depressants, including alcohol, may increase risk
Decreased appetite and decreased weight (46% vs 10% and 27% vs 6%)
  • Reduce valproate by 30% per week
  • Monitor the weight of patients and the growth rate of pediatric patients
Risk in patients with phenylketonuria
  • Consider combined daily amount of phenylalanine from DIACOMIT® Powder for Suspension and all other sources. DIACOMIT® capsules do not contain phenylalanine
Decreased DIACOMIT® concentrations due to induction-based interactions
  • Avoid concomitant use of strong inducers (CYP1A2, CYP3A4, or CYP2C19 inducers, such as rifampin, phenytoin, phenobarbital, or carbamazepine) or adjust doses
Effects on other drugs
  • Reduce doses of substrates of CYP2C8, CYP2C19 (eg, diazepam, clopidogrel), P‑gp (eg, carbamazepine), and BCRP (eg, methotrexate, prazosin, glyburide)
  • Adjust doses of concomitantly administered CYP1A2 substrates (eg, theophylline, caffeine), CYP2B6 substrates (eg, sertraline, thiotepa), and CYP3A4 substrates (eg, midazolam, triazolam, quinidine)
Patient monitoring
Neutropenia and thrombocytopenia (Decrease from baseline: 13% vs 0% and 13% vs 0%)
  • Hematologic testing should be obtained prior to starting treatment with DIACOMIT®, and then every 6 months
Reference:

DIACOMIT® (stiripentol) prescribing information. Beauvais, France: BIOCODEX; 2018.

IMPORTANT SAFETY INFORMATION AND INDICATION
INDICATION

DIACOMIT (stiripentol) capsules for oral use or powder for oral suspension are 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.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

No contraindications are listed.

WARNINGS & PRECAUTIONS
Somnolence

DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

Decreased Appetite and Decreased Weight

DIACOMIT can cause decreases in appetite and weight. The growth and weight of pediatric patients treated with DIACOMIT should be carefully monitored.

Neutropenia and Thrombocytopenia

DIACOMIT can cause significant declines in neutrophil and platelet counts. Hematologic testing should be obtained prior to starting treatment with DIACOMIT and then every 6 months.

Withdrawal Symptoms

As with most antiepileptic drugs (AEDs), DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.

Risks in Patients with Phenylketonuria (PKU)

DIACOMIT powder for suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT powder for suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT powder for suspension. DIACOMIT capsules do not contain phenylalanine.

Suicidal Behavior and Ideation

AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

ADVERSE REACTIONS

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

PREGNANCY

There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Based on animal data, DIACOMIT may cause fetal harm.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (information at http://www.aedpregnancyregistry.org). This can be done by calling the toll free number 1‑888‑233‑23341‑888‑233‑2334, and must be done by patients themselves or their caregiver.

To report suspected adverse reactions, contact BIOCODEX at 1‑866‑330‑30501‑866‑330‑3050 or FDA at 1‑800‑FDA‑10881‑800‑FDA‑1088 or www.fda.gov/medwatch

Please see full prescribing information for DIACOMIT®.