Litfulo Pregnancy Warnings
Safety has not been established during pregnancy. The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Risk summary:
Insufficient data available on use of this drug in pregnant women to inform a risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Comment:
-A pregnancy exposure registry is available.
During animal reproduction studies, when pregnant rats and rabbits were given this drug orally during the organogenesis phase, it resulted in fetotoxicity and fetal malformations. These effects were observed at exposures that were 49 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison in rats and 55 times the MRHD based on AUC comparison in rabbits. There are no controlled data in human pregnancy.
To monitor maternal-fetal outcomes of pregnant women exposed to this drug, a National Pregnancy Registry has been established. Healthcare providers should report exposure of this drug during 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 women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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Litfulo Breastfeeding Warnings
Following the administration of a 30 mg/kg oral dose of this drug to lactating rats, the concentrations of this drug in milk were found to be higher than in plasma. The average ratio of area under the curve (AUC) for milk to plasma was 2.2.
Breastfeeding is not recommended during use of this drug and for 14 hours after the last dose.
Excreted into human milk: Data not available
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Based on its presence in animal milk, it is likely that the drug will be excreted in human milk.
-Since this drug has a potential to cause serious adverse effects in adults, including risks of serious infection and malignancy, breastfeeding is not recommended during use.
See references
