Allogeneic processed thymus tissue Pregnancy and Breastfeeding Warnings
Brand names: Rethymic
Allogeneic processed thymus tissue Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this product in pregnant women to inform a drug-related risk.
Animal studies have not been reported. 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 women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Allogeneic processed thymus tissue Breastfeeding Warnings
Safety has not been established. Benefit should outweigh risk.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
References for pregnancy information
- (2021) "Product Information. Rethymic (allogeneic processed thymus tissue)." Enzyvant Therapeutics Inc., 1
References for breastfeeding information
- (2021) "Product Information. Rethymic (allogeneic processed thymus tissue)." Enzyvant Therapeutics Inc., 1
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
