Is brivaracetam safe for use during breastfeeding?

Brivaracetam and Breastfeeding

Brivaracetam is present in breast milk but breastfeeding can generally continue with appropriate infant monitoring, as the drug appears to transfer at moderate levels (milk/serum ratio ~0.71) and adverse infant effects are rare. 1

FDA Label Guidance

The FDA-approved labeling for BRIVIACT explicitly states that brivaracetam is present in breast milk and instructs patients to discuss breastfeeding intentions with their healthcare provider 1. This acknowledges drug transfer but does not contraindicate breastfeeding, placing the decision in the context of shared clinical decision-making.

Pharmacokinetic Evidence

Research data demonstrates that brivaracetam has a mean milk/serum ratio of 0.71 at 5 days and 3-5 weeks postpartum 2. This indicates moderate transfer into breast milk—higher than drugs like perampanel (ratio 0.13) but lower than complete equilibration. In practical terms, infant serum concentrations have been reported at approximately up to 30% of maternal serum levels in case reports 3.

Clinical Safety Profile

The most comprehensive systematic review on antiseizure medications during breastfeeding found that:

• Adverse infant effects during breastfeeding by mothers on ASMs appear to be rare regardless of the type of ASM 3
• Brivaracetam falls into the moderate transfer category alongside lacosamide and perampanel in limited case reports
• This contrasts with high-transfer drugs like ethosuximide, phenobarbital, and zonisamide (30-100% of maternal levels) where more caution is warranted

Practical Management Algorithm

If prescribing brivaracetam to a breastfeeding mother:

1. Counsel on known drug transfer - Explain the ~0.71 milk/serum ratio and that infant exposure will occur
2. Monitor the infant for:
   • Somnolence/excessive drowsiness
   • Poor feeding
   • Irritability or behavioral changes
3. Consider timing of doses - Though not specifically studied, feeding before the next maternal dose may minimize peak infant exposure
4. Maintain seizure control priority - The well-established benefits of breastfeeding and maternal seizure control generally outweigh theoretical risks 3

Important Caveats

• Limited long-term data: Prospective developmental outcome studies for brivaracetam-exposed breastfed infants are lacking 3
• Individual variability: Infant drug metabolism and maternal pharmacokinetics vary
• Polytherapy considerations: If combined with other ASMs, cumulative sedative effects may increase infant risk

The general principle from epilepsy guidelines is that breastfeeding should be encouraged in women taking ASMs given the well-established benefits for infant health, with individualized counseling about the specific medication 3. For brivaracetam specifically, the moderate milk transfer and rare reported adverse effects support continuation of breastfeeding with appropriate infant monitoring.