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Necitumumab Pregnancy and Breastfeeding Warnings

Necitumumab is also known as: Portrazza

Necitumumab Pregnancy Warnings

Use should be avoided. US FDA pregnancy category: Not assigned Comments: -This drug can cause fetal harm when administered to a pregnant woman. -Pregnant women should be advised of the potential risk to a fetus, and the risk to postnatal development. -Females of reproductive potential should be advised to use effective contraception during treatment with this drug and for 3 months following the final dose.

No animal reproduction studies have been conducted with this drug; however, disruption or depletion of the epidermal growth factor receptor (EGFR) in animal models results in impairment of embryofetal development including effects on placental, lung, cardiac, skin, and neural development. The absence of EGFR signaling has resulted in embryolethality as well as postnatal death in animals. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Necitumumab Breastfeeding Warnings

Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Nursing women should be advised not to breastfeed during treatment with this drug and for 3 months following the final dose. -The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Portrazza (necitumumab)." Eli Lilly and Company, Indianapolis, IN.

References for breastfeeding information

  1. "Product Information. Portrazza (necitumumab)." Eli Lilly and Company, Indianapolis, IN.

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