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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Isolated cases of hypopigmentation occurred after azelaic acid use. ( 5.1 ) • Azelaic acid has been reported to cause irritation of the eyes. Therefore, avoid contact with the eyes and mucous membranes. ( 5.2 ) • Contents are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.3 ) 5.1 Skin Reactions There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. 5.2 Eye and Mucous Membranes Irritation Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If Finacea Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists. 5.3 Flammability The propellant in Finacea Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the prescribing information: • Hypopigmentation [seeWarnings and Precautions ( 5.1 )]. • Eye and Mucous Membranes Irritation [seeWarnings and Precautions ( 5.2 )]. In clinical studies, the most frequently observed adverse reactions in ≥ 0.5% of subjects treated with Finacea Foam included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 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* 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%) * “Application site pain” is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia and tenderness. 6.2 Post-Marketing 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. 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.