Urofollitropin Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Oct 26, 2022.

Urofollitropin is also known as: Bravelle, Fertinex, Metrodin

Urofollitropin Pregnancy Warnings

Use during pregnancy is contraindicated

AU TGA pregnancy category: B2
US FDA pregnancy category: X

Animal studies did not reveal teratogenic effects. There are no adequate or well-controlled studies in pregnant women.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Urofollitropin Breastfeeding Warnings

Contraindicated (UK)
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (US)

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references

Further information

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