Erwinaze Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not Assigned
Risk Summary: Based on animal studies, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-There are no available data on the use of this drug during pregnancy to evaluate for a drug-associated risk to the mother or the fetus.
-Pregnancy testing is recommended in females of reproductive potential before treatment initiation.
-Effective non-hormonal contraceptive methods are recommended during treatment and for 3 months after the last dose.
In animal studies, maternal toxicities of decreased body weight and decreased body weight gain and fetal findings of increased incidence of partially undescended thymic tissue, increased post-implantation loss, decreased number of live fetuses, and gross abnormalities were observed. There are no controlled data in human pregnancy.
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.
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Erwinaze Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There are no data on the presence of this drug in human milk, the effects in the nursing infant, or effects on milk production.
-Advise women not to breastfeed during treatment and for 1 week after the last dose.
See references
