Dasatinib Pregnancy and Breastfeeding Warnings

Dasatinib is also known as: Sprycel

Dasatinib Pregnancy Warnings

Animal studies have shown teratogenicity at plasma levels achievable with therapeutic doses. Malformations and fetal death have occurred in animal studies. Results of repeat-dose toxicity studies in multiple species indicate the potential for this drug 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 studies have also reported that the administration of this drug resulted in uterine inflammation and mineralization, cystic ovaries, and ovarian hypertrophy. 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 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.

Use is not recommended in women who are pregnant or contemplating pregnancy. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Encourage use of adequate methods of contraception in males and females.

Dasatinib Breastfeeding Warnings

Studies in rats have shown excretion into breast milk. Fatalities occurred in some pups with sub-therapeutic plasma levels due to maternal exposure.

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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