Ubrogepant Pregnancy and Breastfeeding Warnings

Brand names: Ubrelvy

Ubrogepant Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are insufficient information in pregnant women to determine a developmental risk; based on animal data,may cause fetal harm.

Comments:
-Data suggests that migraine headaches in pregnant women may increase the risk of preeclampsia and gestational hypertension

In pregnant rabbits, abortion and increased embryofetal mortality was observed in one study and excessive maternal toxicity resulting in early termination and lack of fetal data was observed in a second study at the highest dose tested (250 mg/kg/day). No adverse effects on embryofetal development were observed in pregnant rats receiving doses up to approximately 125 mg/kg/day (45 times the maximum recommended human dose) during the period of organogenesis. Administration to rats throughout gestation and lactation (0, 25, 60, or 160 mg/kg/day) resulted in decreased pup weight at birth and during lactation at the mid and high doses; maternal toxicity was also observed. There are no controlled data in human pregnancy.

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.

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Ubrogepant Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal 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.

Drug levels measured in the milk of lactating rats were comparable to peak plasma concentrations.

See references

Further information

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