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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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation, Silver Spring, MD.

References for breastfeeding information

  1. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation, Silver Spring, MD.

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