Coagulation factor viia Pregnancy and Breastfeeding Warnings

Brand names: NovoSeven RT, Sevenfact

Medically reviewed by Drugs.com. Last updated on Jan 15, 2024.

Coagulation factor viia Pregnancy Warnings

Animal studies have revealed death during early lactation and abortion. Data on a limited number of exposed pregnancies indicate no adverse effects. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

See references

Coagulation factor viia Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

See references

Further information

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