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Brief Summary of Prescribing Information for CEQUA™ (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use CEQUA™ (cyclosporine ophthalmic solution) 0.09% See package insert for Full Prescribing Information. INDICATIONS AND USAGE CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces. Use with Contact Lenses CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution. ADVERSE REACTIONS Clinical Trials Experience 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 practice. In clinical trials, 769 patients received at least 1 dose of cyclosporine ophthalmic solution. The majority of the treated patients were female (83%). The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no adequate and well-controlled studies of CEQUA administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses. Data Animal Data Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight, and skeletal retardations. These doses (normalized to body weight) were approximately 3200 and 21,000 times higher than the maximum recommended human ophthalmic dose (MRHOD) of 1.5 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 1800 and 6400 times higher than the MRHOD, respectively). An oral dose of 45 mg/kg/day cyclosporine (approximately 4800 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (approximately 1600 times greater than the MRHOD). Lactation Risk Summary Cyclosporine blood concentrations are low following topical ocular administration of CEQUA. There is no information regarding the presence of cyclosporine in human milk following topical administration or on the effects of CEQUA on breastfed infants and milk production. Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CEQUA and any potential adverse effects on the breastfed child from cyclosporine. Pediatric Use The safety and efficacy of CEQUA ophthalmic solution have not been established in pediatric patients below the age of 18. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. PATIENT COUNSELING INFORMATION Handling the Vial Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the solution. Advise patients also not to touch the vial tip to their eye to avoid the potential for injury to the eye. Use with Contact Lenses CEQUA should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution. Administration Advise patients that the solution from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. Rx Only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 © 2018 Sun Ophthalmics, a division of Sun Pharmaceutical Industries, Inc. All rights reserved. CEQUA is a trademark of Sun Pharma Global FZE. PLR-00020 2018

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