Azelex

AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

After the skin is thoroughly washed and patted dry, a thin film of AZELEX ® cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX ® cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.

AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

AZELEX ® cream is for dermatologic use only and not for ophthalmic use. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.

During U.S. clinical trials with AZELEX ® cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of AZELEX ® cream. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

Teratogenic Effects Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams. No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Equilibrium dialysis was used to assess human milk partitioning in vitro. At an azelaic acid concentration of 25 mcg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk. However, caution should be exercised when AZELEX ® cream is administered to a nursing mother.

Safety and effectiveness in pediatric patients under 12 years of age have not been established.

Clinical studies of AZELEX ® cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

AZELEX ® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Structural Formula: HOOC-(CH 2) 7 -COOH Chemical Name: 1,7-heptanedicarboxylic acid Empirical Formula: C 9 H 16 O 4 Molecular Weight: 188.22 Active Ingredient: Each gram of AZELEX ® contains azelaic acid......... 0.2 g (20% w/w). Inactive Ingredients: cetearyl octanoate; cetostearyl alcohol; glycerin; glyceryl mono and dipalmitostearate; glyceryl monostearate; isopropyl myristate; PEG-30 stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.

AZELEX ® cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes: 30 g - NDC 16110-869-30 50 g - NDC 16110-869-50 Storage: Protect from freezing. Store product on its side. Store at 15°-30° C (59°-86° F). Revised: 02/2024 Distributed by Almirall, LLC, Malvern, PA 19355, U.S.A. © 2019 Almirall. All right reserved. ® marks owned by Almirall, LLC. Made in Italy by LEO Pharma Manufacturing Italy S.r.l., Segrate (Milan), Italy