Important safety information
INDICATION: Wynzora® (calcipotriene and betamethasone dipropionate) Cream, 0.005%/0.064% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. ADVERSE EVENTS: In the pivotal trial, the most common adverse reactions (≥1%) were: upper respiratory infection (7%), headache (2%), and application site infection (1%). WARNINGS AND PRECAUTIONS: For topical use only. Patients should not use more than 100g of Wynzora® Cream per week. Do not use near or in the mouth, eyes or intravaginally. Avoid using Wynzora® Cream on the face, groin or armpits, or if they have atrophy at the treatment site. Discontinue use once plaque psoriasis is under control or at 8 weeks. Do not use Wynzora® Cream with occlusive dressings. Hypercalcemia and hypercalciuria have been observed with topical use of calcipotriene. Wynzora® Cream can cause reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency during and after withdrawal of treatment. Wynzora® Cream may cause vision problems, including increasing the risk of cataracts and glaucoma. It is not known if Wynzora® Cream may harm your unborn baby. Breastfeeding women should not apply Wynzora® Cream directly to the nipple or areola; it is not known whether topically administered calcipotriene and betamethasone dipropionate is absorbed in human milk.
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References: 1. Pinter A, Iversen L, Praestegaard M, Stein Gold L. Fixed dose calcipotriene (CAL) and betamethasone dipropionate (BDP) cream significantly improves plaque psoriasis at week one in a pooled analysis of phase 3 data. Poster presented at: European Academy of Dermatology and Venereology Congress; September 7-10, 2022; Milan, Italy. 2. Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4):420-425. doi:10.36849/JDD.2021.5653 3. Bewley A, Page B. Maximizing patient adherence for optimal outcomes in psoriasis. J Eur Acad Dermatol Venereol. 2011;25(suppl 4):9-14. doi:10.1111/j.1468-3083.2011.04060.x 4. Praestegaard M, Vestbjerg B, Selmer J, Holm-Larsen T. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62. 5. Wynzora® Cream. Package insert. MC2 Therapeutics; 2020.