Restasis

1 INDICATIONS AND USAGE RESTASIS MULTIDOSE ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. RESTASIS MULTIDOSE is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. ( 1 )

2 DOSAGE AND ADMINISTRATION Instill one drop of RESTASIS MULTIDOSE ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS MULTIDOSE can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products. Prime by squeezing two drops onto a tissue before initial use. ( 2.1 ) Instill one drop of RESTASIS MULTIDOSE ophthalmic emulsion twice a day in each eye approximately 12 hours apart. ( 2.2 ) Pull off the clear shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSETM if shipping cover or pull tab are damaged or missing. Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab. Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap. Prime the bottle for first-time use by squeezing two drops onto a tissue. Do not let the bottle tip touch the tissue. The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing it straight down onto the bottle. Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well. 2.1 Preparation for First-Time Use Step 1: Pull off the clear shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSE if shipping cover or pull tab are damaged or missing. Step 2: Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab. Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap. Step 4: Prime the bottle for first-time use by squeezing two drops onto a tissue. Do not let the bottle tip touch the tissue. Step 5: The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing it straight down onto the bottle. 2.2 Preparation for Use Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well. Step 7: Instill one drop in the affected eye. Replace the olive green colored protective cap.

3 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing cyclosporine 0.05% (0.5 mg/mL) Cyclosporine ophthalmic emulsion 0.05% (0.5 mg/mL) ( 3 )

4 CONTRAINDICATIONS RESTASIS MULTIDOSE is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [ see Adverse Reactions (6.2) ] . Hypersensitivity ( 4 )

5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, be careful not to touch the bottle tip to your eye or other surfaces. ( 5.1 ) 5. 1 Potential for Eye Injury and Contamination Be careful not to touch the bottle tip to your eye or other surfaces to avoid potential for eye injury and contamination. 5.2 Use with Contact Lenses RESTASIS MULTIDOSE should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS MULTIDOSE ophthalmic emulsion.

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Potential for Eye Injury and Contamination [ see Warnings and Precautions (5.1) ] The most common adverse reaction following the use of cyclosporine ophthalmic emulsion 0.05% was ocular burning (17%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion, 0.05% was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring). 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of cyclosporine ophthalmic emulsion, 0.05%. 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. Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the bottle tip touching the eye during administration).

16 HOW SUPPLIED/STORAGE AND HANDLING RESTASIS MULTIDOSE ophthalmic emulsion is packaged in a sterile, multi-dose bottle. Each bottle consists of a white opaque LDPE bottle, a white opaque polypropylene top with unidirectional valve and air filter, a protective olive green polypropylene cap, and a clear disposable shipping cover over the colored cap. RESTASIS MULTIDOSE contains no preservatives. 5.5 mL in 10-mL bottle - NDC 0023-5301-05 Storage: Store at 15°C to 25°C (59°F to 77°F). After opening, RESTASIS MULTIDOSE can be used until the expiration date on the bottle.