For patients with mild to moderate rosacea,
Deliver a spectrum of benefits with FINACEA
®
• The first and only gel approved to treat the inflammatory papules, pustules, and their associated erythema* • Continuous lesion reductions consistent across 12-week pivotal studies1 • Hydrogel formulation that’s nonsticky, alcohol- and fragrance-free2 • Maintains the skin barrier 3
INDICATION & USAGE
IMPORTANT SAFETY INFORMATION
FINACEA (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
FINACEA is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use. FINACEA is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. In clinical trials, sensations of burning/stinging/tingling occurred in 29% of patients, and itching in 11%, regardless of the relationship to therapy. Post-marketing safety—Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure to the eye. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation.
* Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Model used for illustrative purposes only. References: 1. Thiboutot D, Thieroff-Ekerdt R, Graupe K. Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled, randomized phase III studies. J Am Acad Dermatol. 2003;48(6):836-845. 2. Draelos ZD, Graupe K. A new topical formulation for the treatment of mild to moderate papulopustular rosacea: azelaic acid 15% gel. Poster presented at: 61st Annual Meeting of the American Academy of Dermatology; March 21-26, 2003; San Francisco, CA. 3. Draelos ZD. Effects of azelaic acid 15% gel on skin barrier in rosacea. Cosmet Derm. 2008;21(5):259-261.
Please see following page for Brief Summary of full Prescribing Information.
INTENDIS is now © 2012 Bayer HealthCare Inc. Bayer, the Bayer Cross and FINACEA are registered trademarks of Bayer HealthCare Inc. All rights reserved. FIN-10-0001-12 January 2012. Printed in USA.
56 Journal of Dermatology for Physician Assistants