Rufinamide

The Basics

What is Rufinamide?

Used to control seizures in people who have Lennox-Gastaut syndrome.

Brand names for Rufinamide

Rufinamide

How Rufinamide is classified

Anticonvulsants

Rufinamide During Pregnancy

Rufinamide pregnancy category

Category CNote 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 Rufinamide while pregnant

There are no adequate and well-controlled studies in pregnant women. Rufinamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rufinamide produced developmental toxicity when administered orally to pregnant animals at clinically relevant doses. Rufinamide was administered orally to rats at doses of 20,100, and 300 mg/kg per day and to rabbits at doses of 30, 200, and 1,000 mg/kg/day during the period of organogenesis (implantation to closure of the hard palate); the high doses are associated with plasma AUCs ≈2 times the human plasma AUC at the maximum recommended human dose (MRHD, 3,200 mg per day). Decreased fetal weights and increased incidences of fetal skeletal abnormalities were observed in rats at doses associated with maternal toxicity. In rabbits, embryo-fetal death, decreased fetal body weights, and increased incidences of fetal visceral and skeletal abnormalities occurred at all but the low dose. The highest dose tested in rabbits was associated with abortion. The no-effect doses for adverse effects on rat and rabbit embryo-fetal development (20 and 30 mg/kg per day, respectively) were associated with plasma AUCs ≈0.2 times that in humans at the MRHD. In a rat pre- and post-natal development study (dosing from implantation through weaning) conducted at oral doses of 5,30, and 150 mg/kg per day (associated with plasma AUCs up to ≈1.5 times that in humans at the MRHD), decreased offspring growth and survival were observed at all doses tested. A no-effect dose for adverse effects on pre- and postnatal development was not established. The lowest dose tested was associated with plasma AUC < 0.1 times that in humans at the MRHD.

Taking Rufinamide While Breastfeeding

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

Because no information is available on the use of rufinamide during breastfeeding and because it is potentially toxic to the breastfed infant, 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 rufinamide during breastfeeding and because it is potentially toxic to the breastfed infant, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Rufinamide on milk supply

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

Possible alternatives to Rufinamide