Apo-Dasatinib Use In Pregnancy & Lactation

Pregnant Women: Dasatinib can cause fetal harm when administered to pregnant women. There have been post-marketing reports of spontaneous abortion and fetal and infant anomalies from women who have taken dasatinib during pregnancy (see Adverse Reactions). Studies in animals have shown that at concentrations which are readily achievable in humans receiving therapeutic doses of dasatinib, fetal toxicity (embryofetal lethality, skeletal abnormalities including malformations) was observed in both pregnant rats and rabbits. Fetal death was observed in rats.
APO-DASATINIB therefore should not be used in women who are pregnant or contemplating pregnancy. Women of child bearing potential must be advised to use highly effective contraception (i.e. a method of birth control that results in a failure rate less than 1% per year when used consistently and correctly) during APO-DASATINIB treatment. If APO-DASATINIB is used during pregnancy, or if the patient becomes pregnant while taking APO-DASATINIB, the patient should be apprised of the potential hazard to the fetus.
Nursing Women: It is unknown whether dasatinib is excreted in human milk. In an exploratory pre- and post-natal development study in rats, postnatal exposure to dasatinib through lactation resulted in pleural effusion and mortality in pups before postnatal age of 20 days at an exposure of 0.27 times the adult clinical dose. Women who are taking APO-DASATINIB must not breastfeed (see Contraindications).