Lokelma Pregnancy Warnings
Use caution
US FDA pregnancy category: Not assigned
Risk Summary: This drug is not systemically absorbed following oral administration and therefore maternal use is not expected to result in fetal exposure.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. 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.
See references
Lokelma Breastfeeding Warnings
Use is considered acceptable
Excreted into human milk: Not expected (not systemically absorbed)
Excreted into animal milk: Data not available
Comments: This drug is not absorbed systemically following oral administration and therefore breastfeeding is not expected to result in infant exposure.
See references
