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Dasatinib Pregnancy and Breastfeeding Warnings

Dasatinib is also known as: Sprycel

Dasatinib Pregnancy Warnings

Sexually active male or female patients taking dasatinib should use adequate contraception. The effects of dasatinib on human male and female fertility have not been studied. However, results of repeat-dose toxicity studies in multiple species indicate the potential for dasatinib to impair reproductive function and fertility. Effects evident in male animals included immature prostate, seminal vesicle, and testis as well as reduced size and secretion of seminal vesicles. Animal tests have also reported that the administration of dasatinib resulted in uterine inflammation and mineralization, cystic ovaries, and ovarian hypertrophy.

Dasatinib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryo-fetal toxicities including skeletal malformations at multiple sites (scapula, humerus, femur, radius, ribs, clavicle), reduced ossification (sternum; thoracic, lumbar, and sacral vertebrae; forepaw phalanges; pelvis; and hyoid body), edema, microhepatia and fetal death. There are no controlled data in human pregnancy. Dasatinib is not recommended for use in women who are pregnant or contemplating pregnancy.

Dasatinib Breastfeeding Warnings

There are no data on the excretion of dasatinib into human milk. The manufacturer recommends that women who are taking dasatinib do not breast-feed.

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