Azelex Drug Information

® 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.

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.

Pregnancy 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.

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

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