Medesthetics Special

AR Supplement

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For patients with mild to moderate rosacea, Deliver a spectrum of benefits with • The first and only gel approved to treat inflammatory papules, pustules, and associated erythema* (See Indication & Usage below) * • 61% of patients achieved treatment success in 12-week clinical studies1 d • Helps maintain the stratum corneum barrier function2 u • #1 dermatologist-prescribed topical brand for mild to moderate rosacea3 INDICATION & USAGE FINACEA® (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. s *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. IMPORTANT SAFETY INFORMATION FINACEA Gel, 15% is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other components of the formulation. 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. FINACEA and its vehicle caused irritant reactions at the application site in human dermal safety studies. Skin irritation (e.g. pruritus, burning or stinging) may occur during use with FINACEA, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and/or persists during use with FINACEA, discontinue use and institute appropriate therapy. In clinical trials with FINACEA, the most common local adverse events (AE's) (inclusive of mild, moderate and severe categories) were: burning/stinging/ tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/ (29%) (11%) irritation (4%). Contact dermatitis, edema and acne were observed at frequencies of 1% or less. Rarely reported AE's included: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Post-marketing safety information: Skin (facial burning and irritation); Eyes (iridocyclitis on accidental exposure with FINACEA to the eyes). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or FINACEA is for topical use only. It is not for ophthalmic, oral or intravaginal use. In case of accidental eye exposure, wash eyes with large amounts of water and consult a physician if eye irritation persists. Wash hands following application of FINACEA. See following page for Brief Summary of full Prescribing Information. Model used for illustrative purposes only. References: 1. FINACEA [package insert]. Morristown, NJ: Intendis, Inc; 2010. 2. Draelos ZD. Effects of azelaic acid 15% gel on skin barrier in rosacea. Cosmet Derm. 2008;21(5):259-261. 3. Wolters Kluwer Pharma Solutions, Source® Pharmaceutical Audit Suite, July 2010-December 2011. Based on TRx counts, dermatology specialty, inclusive of listed products/strengths only. Wolters Kluwer Health makes no representations regarding the adequacy of its data for the purpose of substantiating any advertising and promotional claims made by Bayer. Bayer remains solely responsible for full compliance with any and all applicable advertising and marketing laws and regulations. Provision of approval for data release for publication is contingent upon Bayer's acknowledgement of sole responsibility for accuracy of the claim made, as well as for compliance with any and all applicable marketing and advertising laws. © 2012 Bayer HealthCare Inc. Bayer, the Bayer Cross and FINACEA are registered trademarks of Bayer HealthCare Inc. All rights reserved. FIN-10-0002-12 May 2012. Printed in USA.

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