Byqlovi®

Pregnancy: No adequate and well-controlled studies in pregnant women. Plasma concentrations after topical ophthalmic dosing are minimal, but corticosteroids including this one are teratogenic and fetotoxic in laboratory animals at relatively low systemic doses. In mice, fetotoxic at the highest subcutaneous dose tested (1 mg/kg, about 98 times the recommended human ophthalmic dose by body surface area) and teratogenic at every dose down to 0.03 mg/kg (about 3 times), with cleft palate and skeletal abnormalities; in rabbits, teratogenic at 3 and 10 mcg/kg subcutaneously (about 1.2 and 3.9 times), with cleft palate, cranioschisis, and skeletal abnormalities. Use only if the potential benefit justifies the potential fetal risk. Background risk in the US general population is 2% to 4% for major birth defects and 15% to 20% for miscarriage.

Lactation: No information on presence in human milk, on the breastfed infant, or on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production, but systemic levels after topical ocular dosing are minimal; weigh the developmental and health benefits of breastfeeding against clinical need.