These highlights do not include all the information needed to use ENSTILAR Foam safely and effectively. See full prescribing information for ENSTILAR Foam.
ENSTILAR® (calcipotriene and betamethasone dipropionate) foam, for topical use
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
Indications and Usage (1) 7/2019
Warnings and Precautions, Ophthalmic Adverse Reactions (5.5) 7/2019
INDICATIONS AND USAGE
Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
Shake before use. (2)
Apply Enstilar Foam to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. (2)
Do not use more than 60 grams every 4 days. (2)
Do not use with occlusive dressings unless directed by a healthcare provider. (2)
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Foam: 0.005%/0.064% - Each gram of Enstilar Foam contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Flammability: The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. (5.1)
Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been observed with use of Enstilar Foam. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. (5.2)
Effects on Endocrine System: Topical corticosteroids can produce 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 corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.3, 8.4)
Ophthalmic Adverse Reactions: Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.5)
ADVERSE REACTIONS
Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2019