Active ingredient Alcaftadine interacts in the following cases:
There are no adequate and well-controlled studies with alcaftadine in pregnant women to inform a drug associated risk. There are limited data with the use of alcaftadine eye drops in pregnant women.
In embryofetal studies in rats and rabbits, oral administration of alcaftadine during the period of organogenesis did not produce maternal or embryofetal toxicity at clinically relevant doses.
Advise pregnant women of a potential risk to the fetus and mother. Alcaftadine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus and mother. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
In rats, oral administration of 5, 20 or 40 mg/kg/day alcaftadine during the period of organogenesis (gestational days 6-16) caused maternal lethality at doses of 40 mg/kg. The no observed adverse effect level (NOAEL) for maternal toxicity was 20 mg/kg/day (an exposure 230-times higher than that at the maximum recommended human ophthalmic dose [MRHOD], based on AUC). There were no adverse embryofetal effects up to a dose of 20 mg/kg.
In rabbits, oral administration of 10, 40 or 80 mg/kg/day alcaftadine during the period of organogenesis (gestational days 6-18) caused no maternal toxicity or adverse embryofetal effects up to a dose of 80 mg/kg/day (an exposure 8819-times higher than that at the MRHOD, based on AUC).
Daily oral doses of 20 and 30 mg/kg/day alcaftadine administered to rats from Day 6 of pregnancy until Day 20 postpartum produced lower pup weights in offspring. No adverse effects in dams or offspring were observed at doses up to 5 mg/kg/day (a dose 286 times higher than the MRHOD, on a mg/m² basis).
There is no information regarding the presence of alcaftadine in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of alcaftadine to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for alcaftadine, and any potential adverse effects on the breastfed infant from alcaftadine.
Carcinogenesis, Mutagenesis and Fertility
The carcinogenic potential of alcaftadine has not been evaluated in long-term animal studies.
Alcaftadine was not mutagenic or genotoxic in the Ames test, the mouse lymphoma assay or the mouse micronucleus assay.
Impairment of Fertility
Alcaftadine was found to have no effect on fertility of male and female rats at oral doses up to 20 mg/kg/day (an exposure 230-times higher than that at the MRHOD, based on AUC).