Application Site Adverse Reactions by Maximum Severity¹

† Adverse reactions not otherwise specified also included in this data.

ACZONE^® (dapsone) Gel 5% is indicated for the topical treatment of acne vulgaris.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hematological effects: oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE^® Gel 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE^® Gel developed laboratory changes suggestive of mild hemolysis.

If signs and symptoms suggestive of hemolytic anemia occur, ACZONE^® Gel 5% should be discontinued. ACZONE^® Gel 5% should not be used in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE^® Gel 5% with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.

Peripheral neuropathy: Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical ACZONE^® Gel 5% treatment.

Skin: Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical ACZONE^® Gel 5% treatment.

ADVERSE REACTIONS:

The most common adverse reactions of ACZONE^® Gel 5% (incidence ≥ 10%) are oiliness/peeling, dryness, and erythema at the application site.

DRUG INTERACTIONS:

Topical application of ACZONE^® Gel followed by benzoyl peroxide in subjects with acne vulgaris resulted in a temporary local yellow or orange discoloration of the skin and facial hair (reported by 7 out of 95 subjects in a clinical study) with resolution in 4 to 57 days.