Wynzora (calcipotriene and betamethasone dipropionate)

Wynzora Cream may cause serious side effects, including:

• Too much calcium in your blood or urine. Your healthcare provider may tell you to stop or temporarily stop treatment with Wynzora Cream if you have too much calcium in your blood or urine.
• Wynzora Cream can pass through your skin. Too much Wynzora Cream passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. Your healthcare provider may tell you to stop or temporarily stop treatment with Wynzora Cream.
• Cushing's syndrome, a condition that happens when your body is exposed to large amounts of the hormone cortisol.
• High blood sugar (hyperglycemia).
• Skin problems. Tell your healthcare provider if you have any skin problems, including:
  • thinning of your skin
  • dryness
  • burning
  • changes in skin color
  • inflammation
  • redness
  • itching
  • infection
  • irritation
  • raised bumps on your skin
• Eye problems. Using Wynzora Cream may increase your chance of getting cataracts and glaucoma. Do not get Wynzora Cream in your eyes because it may cause eye irritation. Tell your healthcare provider if you have blurred vision or other vision problems during treatment with Wynzora Cream.

The most common side effects of Wynzora Cream include upper respiratory infection, headache and irritation at the treatment site.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

• 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.
• There is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production.
• Concentrations of calcipotriene in plasma are low after topical administration, and therefore, concentrations in human milk are likely to be low.