Rimegepant Pregnancy and Breastfeeding Warnings

Brand names: Nurtec ODT

Rimegepant Pregnancy Warnings

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 the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of embryofetal toxicity and teratogenicity. In pregnant rats administered this drug during organogenesis, developmental toxicity occurred at an oral dose associated with maternal toxicity and about 45 times the maximum recommended human dose of 75 mg/day. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers or patients can email nurtecpregnancyregistry@ppd.com, or visit www.nurtecpregnancyregistry.com

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

Use is considered acceptable for mothers of older infants.

Excreted into human milk: Yes

Comments:
-An alternate drug may be preferred while nursing a newborn or preterm infant.
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The amount of this drug in breastmilk is low and breastfed infants are unlikely to experience any adverse effect.
-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 the underlying maternal condition.

A small study reported that after a 75 mg dose of this drug was administered to nursing mothers, nursing infants received a relative dose of 0.51%.

See references

Further information

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

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