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INDICATION AND USAGE

Finacea^® (azelaic acid) Foam, 15% is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

IMPORTANT SAFETY INFORMATION

For topical use only. Finacea Foam is not for oral, ophthalmic or intravaginal use.

Before applying Finacea Foam, cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel.

Apply a thin layer of Finacea Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). Wash hands immediately after application.

Avoid the use of occlusive dressings or wrappings at the application site. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.

Warnings and Precautions

• Hypopigmentation: 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.
• Eye and Mucous Membrane 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 healthcare professional if eye irritation persists.
• 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).

ADVERSE REACTIONS

• In clinical studies, the most frequently observed adverse reactions reported 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%).

USE IN SPECIFIC POPULATIONS

Pregnancy: Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug.

Lactation: Azelaic acid is naturally present in human milk. When used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to Finacea Foam.

Pediatric Use: The safety and efficacy of Finacea Foam have not been established in pediatric patients.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email to usdrugsafety@leo-pharma.com.

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