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ZERVIATE™ (cetirizine ophthalmic solution) 0.24% Brief Summary INDICATIONS AND USAGE ZERVIATE (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis. DOSAGE AND ADMINISTRATION Recommended Dosing: Instill one drop of ZERVIATE in each affected eye twice daily (approximately 8 hours apart). The single-use containers are to be used immediately after opening and can be used to dose both eyes. Discard the single-use container and any remaining contents after administration. The single-use containers should be stored in the original foil pouch until ready to use. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Contamination of Tip and Solution: As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single- use container to avoid injury to the eye and to prevent contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye. Contact Lens Wear: Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE. The preservative in ZERVIATE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE. ADVERSE REACTIONS Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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 7 clinical trials, patients with allergic conjunctivitis or those at risk of developing allergic conjunctivitis received one drop of either cetirizine (N=511) or vehicle (N=329) in one or both eyes. The most commonly reported adverse reactions occurred in approximately 1%–7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There were no adequate or well-controlled studies with ZERVIATE in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m 2 basis). Lactation Risk Summary Cetirizine has been reported to be excreted in human breast milk following oral administration. Multiple doses of oral dose cetirizine (10 mg tablets once daily for 10 days) resulted in systemic levels (Mean C max = 311 ng/mL) that were 100 times higher than the observed human exposure (Mean C max = 3.1 ng/mL) following twice daily administration of cetirizine ophthalmic solution 0.24% to both eyes for 1 week. Comparable bioavailability has been found between the tablet and syrup dosage forms. However, it is not known whether the systemic absorption resulting from topical ocular administration of ZERVIATE could produce detectable quantities in human breast milk. There is no adequate information regarding the effects of cetirizine on breastfed infants, or the effects on milk production to inform risk of ZERVIATE to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZERVIATE and any potential adverse effects on the breastfed child from ZERVIATE. Pediatric Use: The safety and effectiveness of ZERVIATE has been established in pediatric patients two years of age and older. Use of ZERVIATE in these pediatric patients is supported by evidence from adequate and well-controlled studies of ZERVIATE in pediatric and adult patients. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity In a 2-year carcinogenicity study in rats, orally administered cetirizine was not carcinogenic at dietary doses up to 20 mg/kg (approximately 550 times the MRHOD, on a mg/m 2 basis). In a 2-year carcinogenicity study in mice, cetirizine caused an increased incidence of benign liver tumors in males at a dietary dose of 16 mg/kg (approximately 220 times the MRHOD, on a mg/m 2 basis). No increase in the incidence of liver tumors was observed in mice at a dietary dose of 4 mg/kg (approximately 55 times the MRHOD, on a mg/m 2 basis). The clinical significance of these findings during long-term use of cetirizine is not known. Mutagenesis Cetirizine was not mutagenic in the Ames test or in an in vivo micronucleus test in rats. Cetirizine was not clastogenic in the human lymphocyte assay or the mouse lymphoma assay. Impairment of Fertility In a fertility and general reproductive performance study in mice, cetirizine did not impair fertility at an oral dose of 64 mg/kg (approximately 875 times the MRHOD, on a mg/m 2 basis). PATIENT COUNSELING INFORMATION Risk of Contamination: Advise patients not to touch dropper tip to eyelids or surrounding areas, as this may contaminate the dropper tip and ophthalmic solution. Advise patients to keep the bottle closed when not in use. Advise patients to discard single-use containers after each use. Concomitant Use of Contact Lenses: Advise patients not to wear contact lenses if their eyes are red. Advise patients that ZERVIATE should not be used to treat contact lens– related irritation. Advise patients to remove contact lenses prior to instillation of ZERVIATE. The preservative in ZERVIATE solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE. Administration: Advise patients that the solution from one single-use container is to be used immediately after opening. Advise patients that the single-use container can be used to dose both eyes. Discard the single-use container and remaining contents immediately after administration. Storage of Single-use Containers: Instruct patients to store single-use containers in the original foil pouch until ready to use. Rx Only Distributed by: Eyevance Pharmaceuticals LLC. Fort Worth, TX 76102 © 2020 Eyevance Pharmaceuticals LLC. All rights reserved. ZERVIATE™ is a trademark of Eyevance Pharmaceuticals LLC. ZER-04-20-MS-44

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