Solagé 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. 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 Solution 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 Solution. Patients must be advised to use protective clothing and comply with a comprehensive sun avoidance program when using Solagé Solution. Data are not available to establish how or whether Solagé Solution 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 Solution 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 Solution and ensure that the precautions outlined in the Patient Information are observed.

Solagé Solution should be kept out of the eyes, mouth, paranasal creases, and mucous membranes. Solagé Solution 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.

Solagé Solution 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 Solution. 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.

General

For external use only.

Solagé Solution should only be used as an adjunct to a comprehensive skin care and sun avoidance program. (See INDICATIONS section).

If a drug sensitivity, chemical irritation, or a systemic adverse reaction develops, use of Solagé Solution should be discontinued.

Weather extremes, such as wind or cold, may be more irritating to patients using Solagé Solution.

Information for patients

Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The Patient Information is attached to this Package Insert.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Although a dermal carcinogenicity study in CD-1 mice indicated that Solagé Solution applied topically at daily doses up to 80 and 0.4 mg/kg (240 and 1.2 mg/m² ) of mequinol and tretinoin, respectively, representing approximately 5 times the maximum possible systemic human exposure was not carcinogenic, in a photocarcinogenicity study utilizing Crl:Skh-1(hr/hr BR) hairless albino mice, median time to onset of tumors decreased. Also, the number of tumors increased in all dose groups administered 1.4, 4.3 or 14 µl of Solagé Solution/cm² of skin (24 and 0.12, 72 and 0.36, or 240 and 1.2 mg/m² of mequinol and tretinoin, respectively; 0.6, 1.9, or 6.5 times the daily human dose on a mg/m² basis) following chronic topical dosing with intercurrent exposure to ultraviolet radiation for up to 40 weeks. Similar animal studies have shown an increased tumorigenic risk with the use of retinoids when followed by ultraviolet radiation. Although the significance of these studies to human use is not clear, patients using this product should be advised to avoid or minimize exposure to either sunlight or artificial ultraviolet irradiation sources.

Mequinol was non-mutagenic in the Ames/Salmonella assay using strains TA98, TA100, TA1535, and TA1537, all of which are insensitive to mutagenic effects of structurally-related quinones. Solagé Solution was non-genotoxic in an in vivo dermal micronucleus assay in rats, but exposure of bone marrow to drug was not demonstrated.

A dermal reproduction study with Solagé Solution in Sprague-Dawley rats at a daily dose of 80 and 0.4 mg/kg (480 and 2.4 mg/m²) of mequinol and tretinoin, respectively, approximately 11 times the corresponding maximum possible human exposure, assuming 100% bioavailability following topical application to 5% of the total body surface area, showed no impairment of fertility.

Pregnancy: Teratogenic effects: Pregnancy Category X.

Although the magnitude of the potential for teratogenicity may not be well-defined, Solagé Solution is labeled as an “X” because the potential risk of the use of this drug to treat this particular indication (solar lentigines) in a pregnant woman clearly outweighs any possible benefit (see CONTRAINDICATIONS section).

Nursing Mothers: It is not known to what extent mequinol and/or tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Solagé Solution is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of this product have not been established in pediatric patients. Solagé Solution should not be used on children.

Geriatric Use: Of the total number of patients in clinical studies of Solagé Solution, approximately 43% were 65 and older, while approximately 8% were 75 and over. No overall differences in effectiveness or safety were observed between these patients and younger patients.

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