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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypercalcemia and Hypercalciuria : Hypercalcemia and hypercalciuria have been observed with use of topical calcipotriene. If either occurs, discontinue until parameters of calcium metabolism normalize. ( 5.1 ) Effects on Endocrine System: Can cause reversible hypothalamicpituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area, or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. ( 5.2 ) Ophthalmic Adverse Reactions: May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.5 ) 5.1 Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of topical calcipotriene. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. 5.2 Effects on Endocrine System Hypothalamic-Pituitary-Adrenal Axis Suppression WYNZORA Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, gradually withdraw WYNZORA Cream, reduce the frequency of application, or substitute with a less potent corticosteroid. The following trial evaluated the effects of WYNZORA Cream on HPA axis suppression: HPA axis suppression was evaluated in adult subjects (N=27) with extensive psoriasis (including scalp). Adrenal suppression was seen in 6 out of 26 subjects (23%) after 4 weeks of treatment, and in 3 out of 25 subjects (12%) after 8 weeks of treatment [see Clinical Pharmacology (12.2) ]. Cushing's Syndrome and Hyperglycemia Cushing's syndrome and hyperglycemia may occur due to the systemic effects of the topical corticosteroid. These complications generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Additional Considerations for Endocrine Adverse Reactions Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ] . Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to a topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.4 Allergic Contact Dermatitis with Topical Calcipotriene Allergic contact dermatitis has been observed with use of topical calcipotriene. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.5 Ophthalmic Adverse Reactions Use of topical corticosteroids, including WYNZORA Cream, may increase the risks of glaucoma and posterior subcapsular cataract. Cataracts and glaucoma have been reported with the postmarketing use of topical corticosteroid products [see Adverse Reactions (6.2) ]. Avoid contact of WYNZORA Cream with eyes. WYNZORA Cream may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
6 ADVERSE REACTIONS The most common adverse reactions reported by more than 1% of subjects treated with WYNZORA Cream were upper respiratory infection, headache, and application site irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MC2 Therapeutics Ltd at 1-800-644-8240 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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. The rates of adverse reactions given below were reported in a randomized, multicenter, prospective, vehicle and active controlled clinical trial in adult subjects with plaque psoriasis. Subjects applied WYNZORA Cream, calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% or vehicle once daily for 8 weeks. The mean weekly dose of WYNZORA Cream was 33.8 g. A total of 342 subjects were treated with WYNZORA Cream, 337 with calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% and 115 with vehicle. The majority of subjects were White (87%) and male (62%). Approximately 72% were non-Hispanic/Latino. The mean age was 52 years and ages ranged from 18 to 89 years. The most common adverse reactions reported by ≥1% of subjects treated with WYNZORA Cream and more frequently than vehicle are presented in Table 1 below. Table 1: Adverse Reactions Through Week 8 Preferred Term WYNZORA Cream (N=342) Vehicle Cream (N=115) Upper Respiratory Infection (URI) Includes nasopharyngitis, upper respiratory tract infection (URTI), and viral URTI 7% 5% Headache 2% 0% Application site irritation 1% 0% 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of topical corticosteroids. 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. Postmarketing reports for local adverse reactions to topical corticosteroids included: atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria. Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure, have been reported during use of topical corticosteroids, including topical betamethasone products.