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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products. ( 4 , 5.1 ) Skin Irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts abrasions, eczematous or sunburned skin. ( 5.2 ) Photosensitivity : Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. ( 5.3 ) 5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. If a serious hypersensitivity reaction occurs, discontinue TWYNEO immediately and initiate appropriate therapy. 5.2 Skin Irritation Patients using TWYNEO may experience application site dryness, pain, exfoliation, erythema, dermatitis, pruritis, and irritation [ see Adverse Reactions (6.1) ]. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of TWYNEO, or discontinue use. Avoid application of TWYNEO to cuts, abrasions, eczematous, or sunburned skin. 5.3 Photosensitivity TWYNEO may increase sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using TWYNEO. Instruct patients to implement sun protection measures (e.g., sunscreen and loose-fitting clothes) when sun exposure cannot be avoided. Discontinue TWYNEO at the first evidence of sunburn.
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 1%) are pain, dryness, exfoliation erythema, dermatitis, pruritus and irritation (all at the application site). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical trials experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1 )] Skin Irritation [see Warnings and Precautions (5.2) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates are observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 and 2), 832 subjects 9 years of age and older with facial acne vulgaris applied TWYNEO (N=555) or vehicle (N=277) daily for 12 weeks. The majority of subjects were White (73%) and female (59%). Approximately 33% were Hispanic/Latino, and 46% were younger than 18 years of age. Adverse reactions reported in ≥ 1.0% of subjects treated with TWYNEO (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with vehicle are presented in Table 1 . Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with Facial Acne Vulgaris Treated with TWYNEO and More Frequently than Vehicle in Trials 1 and 2 TWYNEO Cream (N = 555) n (%) Vehicle Cream (N = 277) n (%) Application Site Pain* 59 (10.6) 1 (0.4) Application Site Dryness 27 (4.9) 1 (0.4) Application Site Exfoliation 23 (4.1) 0 Application Site Erythema 22 (4.0) 0 Application Site Dermatitis 7 (1.3) 1 (0.4) Application Site Pruritus 7 (1.3) 0 Application Site Irritation 6 (1.1) 1 (0.4) * Application site pain defined as application site stinging, burning or pain. Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, scaling, pigmentation, dryness, itching, burning and stinging. Table 2 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with TWYNEO. Table 2. Facial Cutaneous Tolerability Assessment at Week 12 in Subjects with Acne Vulgaris Treated with TWYNEO TWYNEO (N=494*) (%) Vehicle (N = 264*) (%) Mild Moderate Severe Mild Moderate Severe Erythema 33.0 6.9 0.2 26.9 8.0 0 Pigmentation 27.3 6.3 0.4 26.5 4.5 0 Dryness 22.3 5.3 0.4 16.7 2.3 0 Scaling 16.4 2.6 0 12.9 0.8 0 Burning 5.9 2.2 0 3.4 0.8 0 Itching 11.1 1.8 0 8.7 2.7 0 Stinging 5.3 0.2 0 1.9 1.1 0 * The denominators for calculating the percentages were 494 of 555 subjects treated with TWYNEO and 264 of 277 subjects treated with vehicle in these trials who had cutaneous signs and local tolerability results reported at Week 12. Local tolerability scores for erythema, scaling, dryness, itching, burning and stinging rose during the first two weeks of treatment and decreased thereafter. 6.2 Postmarketing Experience The following adverse reactions have been identified during use of benzoyl peroxide. 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. Immune System Disorders: Anaphylaxis, angioedema and urticaria
adverse reactions table
<table ID="SPLSERV-ef4fba0f-4030-4139-b34a-3cc58ff97109" width="85%"><caption>Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with Facial Acne Vulgaris Treated with TWYNEO and More Frequently than Vehicle in Trials 1 and 2</caption><colgroup><col align="left" valign="middle" width="40%"/><col align="center" valign="top" width="30%"/><col align="center" valign="top" width="30%"/></colgroup><thead><tr><th align="left" styleCode="Lrule Rrule"> </th><th align="center" styleCode="Rrule">TWYNEO Cream (N = 555) n (%)</th><th align="center" styleCode="Rrule">Vehicle Cream (N = 277) n (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Pain*</td><td align="center" styleCode="Rrule">59 (10.6)</td><td align="center" styleCode="Rrule">1 (0.4)</td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Dryness</td><td align="center" styleCode="Rrule">27 (4.9)</td><td align="center" styleCode="Rrule">1 (0.4)</td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Exfoliation</td><td align="center" styleCode="Rrule">23 (4.1)</td><td align="center" styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Erythema</td><td align="center" styleCode="Rrule">22 (4.0)</td><td align="center" styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Dermatitis</td><td align="center" styleCode="Rrule">7 (1.3)</td><td align="center" styleCode="Rrule">1 (0.4)</td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Pruritus</td><td align="center" styleCode="Rrule">7 (1.3)</td><td align="center" styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule">Application Site Irritation</td><td align="center" styleCode="Rrule">6 (1.1)</td><td align="center" styleCode="Rrule">1 (0.4)</td></tr></tbody></table>