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, a phase 1, open-label study was conducted in 12 healthy lactating women (mean age, 29.8 years; mean body mass index, 26.8; 83.3% were White) who were between 2 weeks and 6 months postpartum. Participants were administered a single oral dose of rimegepant 75mg.

Results showed that the relative infant dose was less than 1% of the maternal weight-adjusted dose. The average milk to plasma concentration ratio was 0.20.

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

Data on the effects of rimegepant on a breastfed infant or on milk production are currently unavailable.

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

References

  1. Biohaven announces expanded patient access to Nurtec® ODT (rimegepant), achieving best-in-class commercial insurance coverage and label update. News 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 single-dose rimegepant 75 mg in health lactating women. Breastfeeding Medicine. Published online March 16, 2022. doi.org/10.1089/bfm.2021.0250
  3. Nurtec ODT. Package insert. Biohaven; 2022. Accessed April 14, 2022. https://biohaven-nurtec-consumer-assets.s3.amazonaws.com/nurtec-prescribing-information.pdf