LASTACAFT Solution (Drops) Ref.[9937] Active ingredients: Alcaftadine

5.1 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 in use.

5.2 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 lens-related irritation.

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.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most frequent ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT, were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus.

The most frequent non-ocular adverse reactions, occurring in less than 3% of subjects with eyes treated with LASTACAFT, were nasopharyngitis and headache. Some of these events were similar to the underlying disease being studied.

The following adverse reactions have been identified during post-approval use of LASTACAFT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These reactions include eye discharge, eye swelling, erythema of eyelid, eyelid edema, lacrimation increased, vision blurred, hypersensitivity reactions including swelling of the face or allergic dermatitis, and somnolence.

Risk Summary

There are no adequate and well-controlled studies with LASTACAFT 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. LASTACAFT 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.

Data

Animal Data

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).

Risk Summary

There is no information regarding the presence of LASTACAFT in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of LASTACAFT to an infant during lactation. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for LASTACAFT, and any potential adverse effects on the breastfed infant from LASTACAFT.

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.