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Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older. Gently rub in Enstilar Foam to affected areas once daily for up to 4 weeks. Discontinue use when control is achieved. The maximum dose should not exceed 60 grams every 4 days.
For topical use only. Enstilar Foam is not for oral, ophthalmic or intravaginal use and should not be applied on the face, groin or axillae or if skin atrophy is present at the treatment site. Do not use with occlusive dressings. Patients should wash hands after application.
WARNINGS AND PRECAUTIONS
• Flammability: The propellants in Enstilar Foam are flammable. Instruct patients to avoid fire, flame, and smoking during and immediately following application.
• Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize.
• Effects on Endocrine System: Can cause reversible hypothalamic-pituitary-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.
Cushing’s syndrome, hyperglycemia and glucosuria may occur due to the systemic effects of the topical corticosteroid.
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios.
• Allergic Contact Dermatitis: Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids.
• Ophthalmic Adverse Reactions: May increase the risk of posterior subcapsular cataracts and glaucoma. Avoid contact of Enstilar Foam with eyes. Enstilar Foam may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
ADVERSE REACTIONS
• Adverse reactions reported in <1% of adult subjects included: application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.
• Adverse reactions reported in <1% of pediatric subjects (12-17 years of age) were acne, erythema, application site pain, and skin reactions.
• Postmarketing reports for local adverse reactions to Enstilar Foam included application site burning.
USE IN SPECIFIC POPULATIONS
Pregnancy: Advise pregnant women that Enstilar Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible.
Lactation: No data are available regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk. Use Enstilar Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Enstilar Foam directly to the nipple and areola to avoid direct infant exposure.
Pediatric Use: The safety and effectiveness of Enstilar Foam in pediatric patients less than 12 years of age have not been established. Pediatric patients may be more susceptible to systemic toxicity, HPA axis suppression, and adrenal insufficiency due to their larger skin surface to body mass ratios.
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You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email to usdrugsafety@leo-pharma.com.
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