Brivaracetam

The Basics

What is Brivaracetam?

Used to help control partial onset seizures in the treatment of epilepsy.

Brand names for Brivaracetam

Briviact

How Brivaracetam is classified

Anticonvulsants

Brivaracetam During Pregnancy

Brivaracetam pregnancy category

Category Not AssignedNote 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 Brivaracetam while pregnant

There are no adequate data on the developmental risks associated with use of BRIVIACT in pregnant women. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of brivaracetam(0,150,300,or600mg/kg/day)to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity. The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic. The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD. When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at the MRD. Brivaracetam was shown to readily cross the placenta in pregnant rats after a single oral (5 mg/kg) dose of 14C-brivaracetam. From1 hour post dose, radioactivity levels in fetuses, amniotic fluid, and placenta were similar to those measured in maternal blood.

Taking Brivaracetam While Breastfeeding

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

Because no information is available on use of brivaracetam during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. If brivaracetam is required by the mother, it is not necessarily a reason to discontinue breastfeeding, but monitor the infant for drowsiness, agitation, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of drugs. Measurement of infant serum levels may help rule out toxicity if there is a concern.

Maternal / infant drug levels

Because no information is available on use of brivaracetam during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. If brivaracetam is required by the mother, it is not necessarily a reason to discontinue breastfeeding, but monitor the infant for drowsiness, agitation, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of drugs. Measurement of infant serum levels may help rule out toxicity if there is a concern.

Possible effects of Brivaracetam on milk supply

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

Possible alternatives to Brivaracetam

None listed