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warnings and cautions
5 WARNINGS AND PRECAUTIONS Solagé Topical Solution should not be used if the patient is also taking drugs known to be photosensitizers. (5.1, 7) Solagé Topical Solution is a dermal irritant and the results of continued irritation of the skin for greater than 52 weeks in chronic, long-term use are not known. (5.2) Solagé Topical Solution should be used with utmost caution in irritated or eczematous skin. (5.2) Solagé Topical Solution should only be used as an adjunct to a comprehensive skin care and sun avoidance program. (1, 5.3) Solagé Topical Solution should be used with caution by patients with a history or family history of vitiligo. (5.3) Solagé Topical Solution is flammable. (5.4) 5.1 Augmented Phototoxicity Solagé should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) to treated areas should be avoided or minimized during the use of Solagé. Patients must be advised to use protective clothing and comply with a comprehensive sun avoidance program when using Solagé. Data are not available to establish how or whether Solagé is degraded (either by sunlight or by normal interior lighting) following application to the skin. Patients with sunburn should be advised not to use Solagé until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using Solagé and ensure that the precautions outlined in the Patient Information are observed. Solagé should be kept out of the eyes, mouth, paranasal creases, and mucous membranes. 5.2 Local Events Solagé is a dermal irritant and the results of continued irritation of the skin for greater than 52 weeks in chronic, long-term use are not known. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with utmost caution in patients with this condition. Solagé may cause skin irritation, erythema, burning, stinging or tingling, peeling, and pruritis. If the degree of such local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether. The efficacy at reduced frequencies of application has not been established. 5.3 Precautions: General Solagé should only be used as an adjunct to a comprehensive skin care and sun avoidance program. ( see Indications and Usage [1] ). If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use of Solagé should be discontinued. Weather extremes, such as wind or cold, may be more irritating to patients using Solagé. Solagé should be used with caution by patients with a history, or family history, of vitiligo. One patient in the trials, whose brother had vitiligo, experienced hypopigmentation in areas that had not been treated with study medication. Some of these areas continued to worsen for at least one month post treatment with Solagé. Six weeks later the severity of the hypopigmentation had decreased from moderate to mild and 106 days post treatment, the patient had resolution of some but not all lesions. Application of larger amounts of medication than recommended will not lead to more rapid or better results, and marked redness, peeling, discomfort, or hypopigmentation of the skin may occur. 5.4 Flammable Contents Keep away from heat and open flame.
6 ADVERSE REACTIONS The most common adverse reactions (≥ 5%) in patients in the pivotal clinical trials treated with Solagé Topical Solution were erythema, burning, stinging, or tingling, desquamation, pruritus, skin irritation, halo hypopigmentation, and hypopigmentation. (6.1) In post-marketing reports, the most common adverse reactions were skin discoloration, erythema, skin exfoliation, skin irritation, and skin burning sensation. To report SUSPECTED ADVERSE REACTIONS, contact Stiefel Laboratories, Inc. at 1-866-440-5508 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rate 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 clinical practice. In the pivotal clinical trials, adverse reactions were primarily mild to moderate in intensity, occurring in 66% and 30% of patients, respectively. The majority of these events were limited to the skin and 64% had an onset of a skin related adverse reaction early in treatment (by week 8). The most frequent adverse reactions in patients treated with Solagé were erythema (49% of patients), burning, stinging, or tingling (26%), desquamation (14%), pruritus (12%), and skin irritation (5%). Some patients experienced temporary hypopigmentation of treated lesions (5%) or of the skin surrounding treated lesions (7%). Ninety-four of 106 patients (89%) had resolution of hypopigmentation upon discontinuation of treatment to the lesion, and/or re-instruction on proper application to the lesion only. Another 8% (9/106) of patients with hypopigmentation events had resolution within 120 days after the end of treatment. Three of the 106 patients (2.8%) had persistence of hypopigmentation beyond 120 days. Approximately 6% of patients discontinued study participation with Solagé due to adverse reactions. These discontinuations were due primarily to skin redness (erythema) or related cutaneous adverse reactions. Rare cases of depigmentation at sites distant from the application have been reported in Post Marketing Surveillance. Adverse Events Occurring in >1% of the Population – All Studies Body Sytstem Solagé (mequinol 2%, tretinoin 0.01%) Tretinoin, 0.01% Mequinol, 2%, Vehicle Skin and Appendages N % N % N % N % Erythema 613 41.1 261 55.3 13 5.1 8 4.6 Burning/Stinging/ Tingling 270 18.1 173 36.7 26 10.2 20 11.4 Desquamation 171 11.5 93 19.7 7 2.8 2 1.1 Pruritus 148 9.9 66 14.0 12 4.7 3 1.7 Irritation Skin In study RD.06.SRE.18091 irritant dermatitis included signs & symptoms of scaling, dryness, stinging/burning, and erythema. 90 6.0 25 5.3 1 0.4 1 0.6 Halo Hypopigmentation 96 6.4 16 3.4 2 0.8 2 1.1 Hypopigmentation 62 4.2 8 1.7 2 0.8 0 0.0 Skin Dry 46 3.1 18 3.8 3 1.2 1 0.6 Rash 31 2.0 21 4.4 0 0.0 1 0.6 Crusting 30 2.0 18 3.8 0 0.0 1 0.6 Rash Vesicular Bullae 18 1.2 8 1.7 0 0.0 0 0.0 Dermatitis 29 1.9 0 0.0 0 0.0 0 0.0 Discomfort Skin 52 3.5 0 0.0 0 0.0 0 0.0 Irritant Dermatitis 17 1.1 0 0.0 0 0.0 0 0.0 6.2 Post-marketing Experience The following adverse reactions have been reported during post-approval use of Solagé: skin discoloration, erythema, skin exfoliation, skin irritation, and skin burning sensation. 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.