ALCAFTADINE: 465 Adverse Event Reports & Safety Profile

LASTACAFT® (alcaftadine ophthalmic solution) is an H1 receptor antagonist, in a sterile ophthalmic solution for topical ophthalmic use. Alcaftadine is a white to yellow powder with an empirical formula of C 19 H 21 N 3 O and a molecular weight of 307.39. Contains: Active: alcaftadine 0.25% (2.5 mg/mL) Inactives: benzalkonium chloride 0.005% as a preservative; edetate disodium; sodium phosphate, monobasic; purified water; sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH)

Chemical

Name: 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5 H -imidazo[2,1-b] [3] benzazepine-3-carboxaldehyde Structural Formula: The drug product has a pH of approximately 7 and an osmolality of approximately 290 mOsm/kg. The chemical structure for Chemical Name: 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b] [3] benzazepine-3-carboxaldehyde

AND USAGE LASTACAFT ® is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. LASTACAFT ® is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. ( 1 )

Directions a dults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use c hildren under 2 years of age : consult a doctor

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

REACTIONS The most common ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT ® , were eye irritation, burning and/or stinging on instillation, eye redness, and eye pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 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 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. 6. 2 Postmarketing Experience 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.

AND PRECAUTIONS

• 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 ® .

Drug Facts Active ingredient Alcaftadine 0.25%

INACTIVE INGREDIENTS benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, and water for injection