Information for Healthcare Providers
DIACOMIT® (stiripentol) is an effective, FDA-approved medication that was developed specifically to treat seizures associated with Dravet syndrome. It is indicated for patients 6 months and older (weighing 15 lb or more) taking clobazam. There are no clinical data to support the use of DIACOMIT as a monotherapy.1
Convenient Dosing Options
DIACOMIT is available in 250 mg and 500 mg dosages, with two convenient dosing forms: capsules and fruit-flavored powder. Both forms can be stored at room temperature, making it easy for your patients to take it on the go.
Two Strengths
Two Dosing Forms
Calculating the Proper Dose
DIACOMIT is indicated for patients 6 months and older who weigh 7 kg (15 lb) or more. The recommended oral dosage of DIACOMIT is 50 mg/kg/day, divided into two or three doses (i.e., 16.67 mg/kg three times daily or 25 mg/kg two times daily), depending on your patient’s age and weight.
In the event of a missed dose, DIACOMIT should be taken as soon as possible. If it is almost time for the next dose, the patient should not take the missed dose. Doses should not be doubled. The total maximum dosage is 3,000 mg/day.
|
6 MONTHS TO < 1 YEARa,b |
1 YEAR AND OLDER |
||
|---|---|---|---|
|
BODY WEIGHT |
15 lb + |
15 lb-22 lbb |
22 lb + |
|
STEP 1 Convert weight to kilograms |
15 lb = 7 kg |
18 lb = 8.2 kg |
30 lb = 13.6 kg |
|
STEP 2 Multiply by 50 mg |
7 kg x 50 mg = 350 mg/kg |
8.2 kg x 50 mg = 410 mg/kg |
13.6 kg x 50 mg = 680 mg/kg |
|
STEP 3 Round to nearest dose (250 mg increments) |
Round up to 500 mg |
Round up to 500 mg |
Round up to 750 mg |
|
STEP 4 Divide total into 2 or 3 daily doses |
Divide into 2 doses/day: 250 mg + 250 mg |
Divide into 2 doses/day: 250 mg + 250 mg |
Divide into 2 doses/day: 250 mg + 500 mg – OR – Divide into 3 doses/day: 250 mg + 250 mg + 250 mg |
|
6 MONTHS TO <1 YEARa,b |
|
|---|---|
|
BODY WEIGHT |
15 lb + |
|
STEP 1 Convert weight to kilograms /th> |
15 lb = 7 kg |
|
STEP 2 Multiply by 50 mg |
7 kg x 50 mg = 350 mg/kg |
|
STEP 3 Round to nearest dose (250 mg increments) |
Round up to 500 mg |
|
STEP 4 Divide total into 2 or 3 daily doses |
Divide into 2 doses/day: 250 mg + 250 mg |
|
1 YEAR AND OLDER |
|
|
BODY WEIGHT |
15 lb – 22 lbb |
|
STEP 1 Convert weight to kilograms |
18 lb = 8.2 kg |
|
STEP 2 Multiply by 50 mg |
8.2 kg x 50 mg = 410 mg/kg |
|
STEP 3 Round to nearest dose (250 mg increments) |
Round up to 500 mg |
|
STEP 4 Divide total into 2 or 3 daily doses |
Divide into 2 doses/day: 250 mg + 250 mg |
|
1 YEAR AND OLDER |
|
|
BODY WEIGHT |
22 lb + |
|
STEP 1 onvert weight to kilograms |
30 lb = 13.6 kg |
|
STEP 2 Multiply by 50 mg |
13.6 kg x 50 mg = 680 mg/kg |
|
STEP 3 Round to nearest dose (250 mg increments) |
Round up to 750 mg |
|
STEP 4 Divide total into 2 or 3 daily doses |
Divide into 2 doses/day: 250 mg + 500 mg – OR – Divide into 3 doses/day: 250 mg + 250 mg + 250 mg |
bDosing frequency should not exceed twice daily to avoid overexposures.
For further instruction, please download the full Prescribing Information.
Documenting a Diagnosis
In late 2020, new ICD-10 codes were approved for Dravet syndrome. As you update your patient’s treatment plan to include DIACOMIT, check their record for the following codes:
G40.83: Dravet syndrome, polymorphic epilepsy in infancy (PMEI) or severe myoclonic epilepsy in infancy (SMEI)
G40.833: Dravet syndrome, intractable, with status epilepticus
G40.834: Dravet syndrome, intractable, without status epilepticus
Logging the proper codes can help prevent delays in the access process.
Read the DIACOMIT Access Guide
Our quick checklist outlines what you need to share with our specialty pharmacy to get your patients the treatment they need.
DIACOMIT (stiripentol) Pharmacology
Although the exact mechanism by which DIACOMIT exerts its anticonvulsant effect in humans is unknown, there are two possible mechanisms of action:1
Direct Mediation of GABAA Receptors
Stiripentol is thought to increase activity of GABAA receptors, which enhances GABAergic neurotransmission to block an action potential.1
One study found that stiripentol had the most positive effect on GABAA receptors with an alpha-3 subunit. Since that subunit occurs at the highest levels during youth, it may explain stiripentol’s efficacy in treating a pediatric epilepsy.38
Indirect Effects on Cytochrome P450 Activity
Stiripentol may inhibit cytochrome P450 enzymes, which break down several commonly used antiepileptic drugs, like clobazam. This may enable those drugs to last longer.1,38
In clinical studies, stiripentol increased concentrations of clobazam by about twofold and norclobazam (its active metabolite) by fivefold.1