Stiripentol

The Basics

What is Stiripentol?

Used with clobazam to treat seizures in patients with Dravet syndrome.

Brand names for Stiripentol

Diacomit

How Stiripentol is classified

Anticonvulsants

Stiripentol During Pregnancy

Stiripentol pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Stiripentol while pregnant

There are no adequate data on the developmental risks associated with the use of DIACOMIT in, pregnant women. Administration of stiripentol to pregnant animals produced evidence of, developmental toxicity, including increased incidences of fetal malformations, increased, embryofetal and pup mortality, and decreased embryofetal and pup growth, at maternal doses, lower than the recommended clinical dose [see Animal Data]., The background risk of major birth defects and miscarriage in Dravet syndrome is unknown. In, the U.S. general population, the estimated background risk of major birth defects and miscarriage, in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Oral administration of stiripentol (0, 50, 200, or 800 mg/kg/day) to pregnant mice throughout the, period of organogenesis resulted in increased embryofetal mortality and decreased fetal body, weights at all doses and an increased incidence of malformations at the high dose, with no, evidence of maternal toxicity. The lowest effect dose for developmental toxicity in mice (50, mg/kg/day) was less than the recommended human dose (RHD) of 50 mg/kg/day on a body, surface area (mg/m2, ) basis., Oral administration of stiripentol (0, 50, 200, or 800 mg/kg/day) to pregnant rabbits throughout, organogenesis resulted in increased embryofetal mortality at the mid and high dose and, decreased fetal body weights at all doses. The mid and high doses were associated with maternal, toxicity. The lowest effect dose for developmental toxicity in rabbits (50 mg/kg/day) was less, than the RHD on a mg/m2 basis., Oral administration of stiripentol (0, 50, 200, or 800 mg/kg/day) to rats throughout pregnancy, and lactation resulted in decreased pup survival, decreased pup body weights at birth and, throughout lactation, and deficits in pup reflex development at the high dose, which was also, associated with maternal toxicity. The no-effect dose for pre- and postnatal developmental, toxicity in rats (200 mg/kg) was less than the RHD on a mg/m2 basis. 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. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Administration of stiripentol to pregnant animals produced evidence of developmental toxicity, including increased incidences of fetal malformations, increased embryofetal and pup mortality, and decreased embryofetal and pup growth, at maternal doses lower than the recommended clinical dose [see Animal Data]. The background risk of major birth defects and miscarriage in Dravet syndrome is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Taking Stiripentol While Breastfeeding

What are recommendations for lactation if you're taking Stiripentol?

Because no information is available on the use of stiripentol during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

Because no information is available on the use of stiripentol during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Stiripentol on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Stiripentol

None listed