Lactation education

Labeling for migraine treatment Rimegepant updated with lactation data

The prescribing information for rimegepant (Nurtec® ODT) has been updated to include clinical lactation data.

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the acute treatment of migraine with or without aura and for the preventive treatment of episodic migraine.

To assess the concentration of rimegepant in plasma and human milk, an open label phase 1 study was conducted in 12 healthy lactating women (mean age, 29.8 years; mean body mass index, 26.8; 83 .3% were Caucasian) who were between 2 weeks and 6 months postpartum. Participants received a single oral dose of rimegepant 75 mg.

The results showed that the relative infant dose was less than 1% of the weight-adjusted maternal dose. The mean milk/plasma concentration ratio was 0.20.

“Our data showed that the excretion of rimegepant in human milk is very low and that rimegepant was well tolerated by lactating women, providing them with an option for the acute and preventive treatment of migraine,” said Elyse Stock, MD, Chief Medical Officer at Biohaven.

Data on the effects of rimegepant on a nursing infant or on milk production are currently not available.

Nurtec ODT is supplied as an orally disintegrating tablet containing 75mg of rimegepant.

References

  1. Biohaven Announces Expanded Patient Access to Nurtec® ODT (rimegepant), getting the best trade assurance coverage and label update. Press release. April 14, 2022. https://www.prnewswire.com/news-releases/biohaven-announces-expanded-patient-access-to-nurtec-odt-rimegepant-achieving-best-in-class-commercial-insurance-coverage-and-label- update-301525740.html
  2. Baker T, Croop R, Kamen L, et al. Human milk and plasma pharmacokinetics of rimegepant 75 mg single dose in healthy lactating women. Breastfeeding medicine. Published online March 16, 2022. doi.org/10.1089/bfm.2021.0250
  3. Nurtec ODT. Packing note. Biological haven; 2022. Accessed April 14, 2022. https://biohaven-nurtec-consumer-assets.s3.amazonaws.com/nurtec-prescribe-information.pdf