Enstilar (calcipotriene and betamethasone dipropionate)

Enstilar Foam is a prescription medicine used on the skin (topical) to treat plaque psoriasis in people 12 years of age and older. It is not known if Enstilar Foam is safe and effective in children under 12 years of age.

Enstilar Foam 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 Enstilar Foam if you have too much calium in your blood or urine.
• Enstilar Foam can pass through your skin. Too much Enstilar Foam 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.
• Cushing's syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
• High blood sugar (hyperglycemia) and sugar in your urine.

Your healthcare provider may do blood and urine tests to check your calcium levels and adrenal gland function while you are using Enstilar Foam.

• Skin problems, including reactions where Enstilar Foam is applied, and allergic reactions (allergic contact dermatitis).
• Eye problems. Using Enstilar Foam may increase your chance of getting cataracts and glaucoma. Do not get Enstilar Foam 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 Enstilar Foam.

The most common side effects of Enstilar Foam include:

• irritation
• itching
• inflamed hair pores (folliculitis)
• changes in skin color
• rash with raised red bumps or skin welts (hives)
• worsening of your psoriasis

These are not all the possible side effects of Enstilar Foam.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

Instruct patients to shake can prior to using Enstilar Foam and to wash their hands after applying the product. Apply Enstilar Foam to affected areas once daily for up to 4 weeks. Rub in Enstilar Foam gently. Discontinue Enstilar Foam when control is achieved. Patients should not to use more than 60 grams every 4 days.

Enstilar Foam should not be:

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

Enstilar Foam is not for oral, ophthalmic, or intravaginal use.

• Available data with Enstilar Foam 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 Enstilar Foam 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.