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Lenvatinib Pregnancy and Breastfeeding Warnings

Lenvatinib is also known as: Lenvima

Lenvatinib Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity. Oral doses given to animals below the recommended human dose resulted in increased fetal external, visceral, and skeletal anomalies; delayed fetal ossifications; decreased fetal body weight; increased postimplantation loss; and late abortions. There are no controlled data in human pregnancy. 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.

Use should be avoided as the drug can cause fetal harm. US FDA pregnancy category: Not assigned Comments: -Females of reproductive potential should use effective contraception during treatment and for at least 2 weeks after discontinuation of the drug. -Animal studies suggest this drug has potential to impair female fertility and cause damage to male reproductive tissues, resulting in reduced fertility of unknown duration.

See references

Lenvatinib Breastfeeding Warnings

Discontinue breastfeeding during treatment. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: This drug has the potential to cause harm to a nursing infant based on findings from animal studies. This drug and its metabolites are excreted in animal milk at concentrations higher than in maternal plasma.

See references

References for pregnancy information

  1. "Product Information. Lenvima (lenvatinib)." Eisai Inc, Woodcliff Lake, NJ.

References for breastfeeding information

  1. "Product Information. Lenvima (lenvatinib)." Eisai Inc, Woodcliff Lake, NJ.

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