FINACEA FOAM

1 INDICATIONS AND USAGE FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. FINACEA Foam is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. ( 1 )

2 DOSAGE AND ADMINISTRATION Shake well before use. Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of FINACEA Foam. Apply FINACEA Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). For a single application, dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer. Use FINACEA Foam continuously over 12 weeks. Wash hands immediately following application of FINACEA Foam. Cosmetics may be applied after the application of FINACEA Foam has dried. Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy. Avoid the use of occlusive dressings or wrappings. Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. For topical use. Not for oral, ophthalmic or intravaginal use. Apply a thin layer twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). ( 2 ) Use only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Foam. ( 2 ) Wash hands immediately following application. ( 2 ) Cosmetics may be applied after the application of FINACEA Foam has dried. ( 2 ) Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. ( 2 ) For topical use. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

Not available.

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the prescribing information: Hypopigmentation [see Warnings and Precautions (5.1) ]. Eye and Mucous Membranes Irritation [see Warnings and Precautions (5.2) ]. The most common adverse reactions (incidence ≥ 0.5% of subjects treated with FINACEA Foam) are local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 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. FINACEA Foam was evaluated for the treatment of papulopustular rosacea in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1362 (FINACEA Foam, 15%: 681; vehicle: 681) subjects. Overall, 95.7% of subjects were White, 73.4% were female, and the mean age was 50.6 years. Table 1: Adverse Reactions Occurring in ≥ 0.5% of Subjects Treated with FINACEA Foam Compared with Subjects Treated with Vehicle System/Organ Class Preferred FINACEA Foam, 15% (N=681) n (%) Vehicle (N=681) n (%) General disorders and application site conditions Application site pain "Application site pain" is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia and tenderness. 42 (6.2%) 10 (1.5%) Application site pruritus 17 (2.5%) 2 (0.3%) Application site dryness 5 (0.7%) 5 (0.7%) Application site erythema 5 (0.7%) 6 (0.9%) Local Tolerability Studies In a 21-day cumulative irritation study under occlusive conditions, mild-to-moderate irritation was observed for azelaic acid pre-foam emulsion. In a human repeat insult patch test (HRIPT) study, no sensitization potential was observed for azelaic acid pre-foam emulsion. 6.2 Postmarketing Experience Hypersensitivity, rash and worsening of asthma have been reported from the postmarketing experience of azelaic acid-containing formulations. 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.