Included as part of the PRECAUTIONS section.
Potential For Eye Injury And Contamination
To minimize eye injury and contamination of the dropper
tip and solution, care should be taken not to touch the eyelids or surrounding
areas with the dropper tip of the bottle. Keep bottle tightly closed when not
Contact Lens Use
Patients should be advised not to wear a contact lens if
their eye is red.
LASTACAFT® should not be used to treat contact
LASTACAFT® should not be instilled while
wearing contact lenses. Remove contact lenses prior to instillation of
LASTACAFT®. The preservative in LASTACAFT®, benzalkonium
chloride, may be absorbed by soft contact lenses. Lenses may be reinserted
after 10 minutes following administration of LASTACAFT®.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Alcaftadine was not mutagenic or genotoxic in the Ames
test, the mouse lymphoma assay or the mouse micronucleus assay.
Alcaftadine was found to have no effect on fertility of
male and female rats at oral doses up to 20 mg/kg/day (approximately 200 times
the plasma exposure at the recommended human ocular dose).
Use In Specific Populations
Pregnancy Category B. Reproduction studies
performed in rats and rabbits revealed no evidence of impaired female
reproduction or harm to the fetus due to alcaftadine. Oral doses in rats and
rabbits of 20 and 80 mg/kg/day, respectively, produced plasma exposure levels
approximately 200 and 9000 times the plasma exposure at the recommended human
ocular dose. There are however, no adequate and well controlled studies in
pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when LASTACAFT® is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the
age of 2 years have not been established.
No overall differences in safety or effectiveness were
observed between elderly and younger subjects.