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Lenvatinib Pregnancy and Breastfeeding Warnings

Lenvatinib is also known as: Lenvima

Medically reviewed on Aug 21, 2018

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. Testicular and ovarian toxicity was also reported. 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.

Use should be avoided.

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

Risk Summary: This drug caused embryotoxicity, fetotoxicity, and teratogenicity in animal studies when given during organogenesis at doses below the human recommended equivalent doses.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Women of childbearing potential should use effective contraception during therapy and for at least 30 days after.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.

See references

Lenvatinib Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for at least 1 week after.

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.

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