Lastacaft

LASTACAFT ® is contraindicated in patients with hypersensitivity to any component in the product. Hypersensitivity ( 4 )

• Potential for Eye Injury and Contamination :
• To minimize the risk of eye injury and contamination, do not touch dropper tip to eyelids and surrounding areas, or any other surface. Keep bottle tightly closed when not in use. ( 5.1 )
• Contact Lens Wear:
• LASTACAFT ® should not be used to treat contact lens-related irritation. Remove contact lenses prior to instillation of LASTACAFT ® . ( 5.2 ) 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 ® .

• 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).
• IN SPECIFIC POPULATIONS
• 8.1 Pregnancy 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). 8. 2 Lac t ation 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 ® .
• 8.4 Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
• 8.5 Geriatric Use No overall differences in safety or effectiveness were observed between elderly and younger subjects.