Caprelsa Pregnancy Warnings
Avoid pregnancy; may cause fetal harm.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments: Avoid pregnancy during and for 4 months following treatment. Women of childbearing potential should be advised to use effective contraception.
In rats exposed to drug concentrations less than or equal to those expected at the recommended human dose, vandetanib was embryotoxic, fetotoxic, and teratogenic. Additionally, pre-implantation and post-implantation losses were observed resulting in a reduction in the number of live embryos. A dose dependent increase in both malformations of the heart vessels and skeletal problems were observed whereas, a no effect level for malformations was not identified. In pups of mothers who received vandetanib during gestation and/or lactation, decreased pup survival and/or post-natal pup growth, including delay in physical development occurred. There are no adequate and well-controlled studies in pregnant women.
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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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Caprelsa Breastfeeding Warnings
UK: Use is contraindicated.
AU and US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
There is no data on drug excretion into human milk, however, the drug and its metabolites are excreted into the milk of lactating rats. In pups receiving rat milk, plasma concentrations were relatively constant due to the long half-life of the drug.
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