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Lenvatinib Pregnancy and Breastfeeding Warnings

Lenvatinib is also known as: Lenvima

Lenvatinib Pregnancy Warnings

This drug caused embryotoxicity, fetotoxicity, and teratogenicity in animal studies at doses below the recommended human doses. Testicular and ovarian toxicity has been observed in animals. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

This drug should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Females of reproductive potential should be advised to avoid becoming pregnant while being treated with this drug.
-Women of childbearing potential should use effective contraception during therapy and for at least 30 days after.
-Females using oral hormonal contraceptives should additionally use a barrier method of contraception.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Based on animal and the drug mechanism of action, this drug can cause fetal harm.

See references

Lenvatinib Breastfeeding Warnings

Use should be avoided.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Nursing women should be advised to discontinue breastfeeding during treatment with this drug and for at least one week after the last dose.

No information is available on the use of this drug during breastfeeding. Because it is more than 98% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 28 hours and it might accumulate in the infant.

See references

References for pregnancy information

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

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Lenvima (lenvatinib)." Eisai Inc, Woodcliff Lake, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.