Tanzeum Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Comments:
-Women of childbearing potential should be encouraged to use effective contraception.
-This drug should be stopped 1 month prior to a planned pregnancy due to its long washout period.
Animal studies in mice have not shown teratogenicity; reduced estrous cycling at maternally toxic doses has been observed in mice, although no harmful effects with respect to fertility were observed. The potential risk to human fertility is unknown. There are no adequate and well-controlled studies in pregnant women.
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.
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Tanzeum Breastfeeding Warnings
Decreased body weight has been observed in the offspring of mice whose moms were treated with this drug during gestation and lactation. There are no data of use during lactation in humans.
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: Data not available
Comment: Since this drug is an albumin-based protein therapeutic, it is likely to be present in human milk.
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