Coagulation factor viia Pregnancy and Breastfeeding Warnings
Coagulation factor viia is also known as: NovoSeven RT, Sevenfact
Medically reviewed by Drugs.com. Last updated on Jan 14, 2020.
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
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.
References for pregnancy information
- "Product Information. NovoSeven (coagulation factor VIIa)" Novo Nordisk Pharmaceuticals, Princeton, NJ.
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. NovoSeven (coagulation factor VIIa)" Novo Nordisk Pharmaceuticals, Princeton, NJ.
See Also...
Further information
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