Vandetanib Pregnancy and Breastfeeding Warnings

Vandetanib is also known as: Caprelsa

Vandetanib Pregnancy Warnings

Vandetanib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryofetotoxicity, embryolethality, and teratogenicity. There are no controlled data in human pregnancy. According to the manufacturer, use of vandetanib during pregnancy is not recommended. If vandetanib is used during pregnancy or if the patient becomes pregnant during treatment, the patient should be advised of the potential hazard to the developing fetus. Women of childbearing potential should avoid becoming pregnant during treatment and they should be encouraged to use adequate methods of contraception during administration of vandetanib and for at least 4 months after treatment has been discontinued.

Use of vandetanib in rats, at doses equivalent to or lower than those expected in humans, was associated with pre- and postimplantation loss (including embryofetal death), malformations of the heart vessels, delayed ossification of the skull, vertebrae, and sternum, decreased pup survival, and/or reduced postnatal pup growth (including delayed physical development).

Vandetanib Breastfeeding Warnings

There are no data on the excretion of vandetanib into human milk; however, it is excreted into the milk of lactating rats. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother.

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