Sprycel 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Use is not recommended.
AU TGA pregnancy category: D
US FDA pregnancy category: Not Assigned
Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Women must be advised to avoid becoming pregnant while on therapy.
-Sexually active male or female patients of childbearing potential should use adequate contraception.
See references
Sprycel Breastfeeding Warnings
Animal studies have shown excretion into breast milk. Fatalities occurred in some pups with sub-therapeutic plasma levels due to maternal exposure.
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-Advice not to breastfeed while on therapy and for at least 2 weeks after the final dose.
-The effects in the nursing infant and on milk production are unknown.
See references
