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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. ( 5.1 ) • Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Adapalene and Benzoyl Peroxide gel and may necessitate discontinuation. ( 5.2 ) 5.1 Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during the use of Adapalene and Benzoyl Peroxide gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel (e.g., hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with Adapalene and Benzoyl Peroxide gel. 5.2 Local Cutaneous Reactions Erythema, scaling, dryness, and stinging/burning may be experienced with use of Adapalene and Benzoyl Peroxide gel. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur. Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of Adapalene and Benzoyl Peroxide gel, or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with Adapalene and Benzoyl Peroxide gel. Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
6 ADVERSE REACTIONS Most commonly reported adverse reactions (≥1%) in patients treated with Adapalene and Benzoyl Peroxide gel were skin irritation, eczema, atopic dermatitis, and skin burning sensation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During the Phase 3 clinical trial, 217 subjects were exposed to Adapalene and Benzoyl Peroxide gel. A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with Adapalene and Benzoyl Peroxide gel and for which the rate with Adapalene and Benzoyl Peroxide gel exceeded the rate for the vehicle gel are presented in Table 1: Table 1. Adverse Reactions Occurring in ≥ 1% of Subjects with Acne Vulgaris in a 12-week Clinical Trial Adapalene and Benzoyl Peroxide Gel 0.3%/2.5% (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) Vehicle Gel (N=69) Skin irritation 4% <1% 0% Eczema 1% 0% 0% Dermatitis atopic 1% 0% 0% Skin burning sensation 1% 0% 0% Local tolerability evaluations presented in Table 2, were conducted at each study visit in the clinical trial by assessment of erythema, scaling, dryness, and stinging/burning, which peaked at Week 1 of therapy and decreased thereafter. Table 2. Incidence of Local Cutaneous Irritation in 12-week Clinical Trial in Subjects with Acne Vulgaris Maximum Severity During Treatment End of Treatment Severity (Final Score) Moderate Severe Moderate Severe Adapalene and Benzoyl Peroxide Gel 0.3%/2.5% (N=213) Erythema 20% 1% 4% <1% Scaling 17% 1% 1% <1% Dryness 15% 2% 3% <1% Stinging/Burning 19% 6% 1% 1% Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212) Erythema 15% 1% 2% <1% Scaling 12% <1% 2% 0% Dryness 13% 1% 2% 0% Stinging/Burning 14% 9% 3% 0% Vehicle Gel (N=68) Erythema 6% 1% 1% 0% Scaling 6% 0% 1% 0% Dryness 4% 1% 1% 0% Stinging/Burning 3% 1% 0% 0% 6.2 Post-Marketing Experience There is no post-marketing experience with Adapalene and Benzoyl Peroxide gel. The following adverse reactions have been identified during post-approval use of Adapalene and Benzoyl Peroxide gel, a similar drug containing 0.1% adapalene and 2.5% benzoyl peroxide as the active ingredients: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.