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Rimegepant Pregnancy and Breastfeeding Warnings

Brand names: Nurtec ODT

Rimegepant Pregnancy Warnings

Safety has not been established. Manufacturer makes no recommendation on the use of this drug.
-According to some authorities, use should be avoided.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: Inadequate data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of decreased fetal body weight and increased incidence of fetal variations at exposures associated with maternal toxicity and greater than those expected clinically in pregnant rats. In rabbits, administration during the period of organogenesis resulted in no adverse effects on embryofetal development at doses expected to be approximately 10 times the maximum recommended human dose. Prenatal and postnatal development studies in rats were inadequate to assess for adverse effects during these periods of development. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Rimegepant Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Yes

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

This drug is highly bound to plasma proteins (96%) so if this drug were excreted into milk, levels are likely low.

A lactation study was conducted in 12 breast-feeding women who were between 2 weeks and 6 months post-partum and were administered a single dose of 75 mg of this drug. The results have established an average milk-to-plasma ratio of 0.20 and a relative infant dose of less than 1% of the maternal weight-adjusted dose.

See references

References for pregnancy information

  1. Product Information. Nurtec ODT (rimegepant). Biohaven Pharmaceuticals. 2020.
  2. Product Information. Nurtec ODT (rimegepant). Pfizer Australia Pty Ltd. 2023.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  2. Product Information. Nurtec ODT (rimegepant). Biohaven Pharmaceuticals. 2020.
  3. Product Information. Nurtec ODT (rimegepant). Pfizer Australia Pty Ltd. 2023.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.