Lotilaner ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Xdemvy
Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.
Lotilaner ophthalmic Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-As more than 99% of drug is bound to plasma proteins, its systemic exposure after ocular administration is expected to be low.
Animal studies have failed to reveal evidence of fetal malformations after ocular administration. In an oral embryofetal developmental study, increased post-implantation loss, reduced fetal pup weight, and incomplete skeletal ossification were observed at doses 1390 times the recommended human ophthalmic dose (RHOD). The NOAEL (no observable adverse effect limit) was determined to be 5 mg/kg/day (139 times the RHOD on a body surface area basis). There are no controlled data in human pregnancy.
Animal studies have revealed evidence of reduced pregnancy and decreased implantation rates in female rats at oral doses of 20 mg/kg/day (approximately 556 times the RHOD on a body surface area basis), which were also associated with maternal toxicity (i.e., decreased body weight and food consumption).
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.
Lotilaner ophthalmic Breastfeeding Warnings
Safety has not been established. Benefit should outweigh risk.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Systemic exposure to this drug was low after 6 weeks of topical ocular administration, and the drug is more than 99% protein-bound.
See also
References for pregnancy information
- (2023) "Product Information. Xdemvy (lotilaner ophthalmic)." Tarsus Pharmaceuticals, Inc.
References for breastfeeding information
- (2023) "Product Information. Xdemvy (lotilaner ophthalmic)." Tarsus Pharmaceuticals, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
