Wynzora

WYNZORA Cream is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Apply WYNZORA Cream to affected areas once daily for up to 8 weeks. Rub in gently to ensure that the plaques are saturated with the cream.

Do not use more than 100 g per week.

Discontinue therapy when control is achieved.

Do not use:

• with occlusive dressings unless directed by a healthcare provider
• on the face, groin, or axillae, or if skin atrophy is present at the treatment site

WYNZORA Cream is not for oral, ophthalmic, or intravaginal use.

Cream: 0.005%/0.064%.

Each gram of WYNZORA Cream contains 50 mcg of calcipotriene and 0.644 mg of betamethasone dipropionate in a white cream.

Available data with WYNZORA Cream are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of WYNZORA Cream is likely to be low

Observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids

In animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs

The background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

• Hypercalcemia and Hypercalciuria
  : Hypercalcemia and hypercalciuria have been observed with use of topical calcipotriene. If either occurs, discontinue until parameters of calcium metabolism normalize.
• 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.
• Ophthalmic Adverse Reactions:
  May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.