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IMPORTANT SAFETY INFORMATION

WARNINGS & PRECAUTIONS

SleepinessDIACOMIT can cause sleepiness. Your healthcare provider should monitor you for sleepiness, particularly when DIACOMIT is used with other depressants or clobazam.

Decreased Appetite and WeightDIACOMIT can cause a loss in appetite and weight. Your healthcare provider should monitor your growth and weight carefully.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

DIACOMIT (stiripentol) is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam and who are 6 months of age or older and weigh 15 pounds or more. There are no clinical data to support the use of DIACOMIT alone in Dravet syndrome.

WARNINGS & PRECAUTIONS

Sleepiness

DIACOMIT can cause sleepiness. Your healthcare provider should monitor you for sleepiness, particularly when DIACOMIT is used with other depressants or clobazam.

Decreased Appetite and Weight

DIACOMIT can cause a loss in appetite and weight. Your healthcare provider should monitor your growth and weight carefully.

Changes in Blood Cell Counts

DIACOMIT can cause significant declines in white blood cell and platelet counts so your blood should be tested prior to starting treatment with DIACOMIT and then every 6 months.

Withdrawal Symptoms

As with most antiepileptic drugs, DIACOMIT should be gradually withdrawn to lessen the risk of higher seizure frequency and status epilepticus, which is when a seizure lasts longer than five minutes or you are unable to fully recover from multiple seizures over five minutes or more.

Risks in Patients with Phenylketonuria

DIACOMIT for oral suspension contains phenylalanine, which can be harmful if you have a condition called phenylketonuria. Talk to your healthcare provider about your total daily intake of phenylalanine from all sources, including DIACOMIT. DIACOMIT capsules do not contain phenylalanine.

Suicidal Behavior and Ideation

DIACOMIT can increase the risk of suicidal thoughts or behavior. Your healthcare provider should monitor you for worsening depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

SIDE EFFECTS

The most common side effects that occurred in at least 10% of patients treated with DIACOMIT in clinical studies and more frequently than patients in the placebo group were sleepiness, decreased appetite, agitation, lack of muscle coordination, decreased weight, decreased muscle tone, nausea, tremor, slurred speech, and trouble sleeping.

PREGNANCY

There is no adequate information about the risks of use of DIACOMIT in pregnant women. Based on information in animals, DIACOMIT may cause fetal harm. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DIACOMIT during pregnancy. To enroll, you can call the toll free number 1-888-233-2334.

To report suspected adverse reactions, contact Biocodex at 1-866-330-3050 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for DIACOMIT^®.

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