Dinutuximab Pregnancy and Breastfeeding Warnings

Dinutuximab is also known as: Unituxin

Dinutuximab Pregnancy Warnings

Use is not recommended. US FDA pregnancy category: Not formally assigned to a pregnancy category. Comments: -This drug may cause fetal harm. -Females of reproductive potential should be advised to use effective contraception during treatment and for two months after the last dose of this drug.

-This drug may cause fetal harm when administered to a pregnant woman based on its mechanism of action. There are no studies in animals or human pregnant women to assess the drug-associated risk. -Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. Pregnant women should be advised of the potential risk to a fetus. The background risk of major birth defects and miscarriage pregnant women is unknown; however, the background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

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Dinutuximab 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; however, human IgG is present in human milk Excreted into animal milk: Data not available Comments: -There is no information on the effects of the drug on the breastfed infant. -There is no information on the effects of the drug on milk production.

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