ENSTILAR

AbsorptionThe PK of Enstilar Foam was investigated in both adults (N = 35) and a subset of pediatric subjects with plaque psoriasis age 12 to 17 years (N=33) following once daily application of Enstilar Foam on the body and scalp for 4 weeks. Enstilar Foam was applied to adult subjects with moderate to severe plaque psoriasis affecting a mean body surface area of 18% and mean scalp area of 50%. Following application of a mean ± SD weekly dose of 62 ± 28 grams of Enstilar Foam, calcipotriene was...

Two multicenter, randomized, double-blind trials were conducted in adult subjects with plaque psoriasis. In Trial One, 302 subjects were randomized to 1 of 3 treatment groups: Enstilar ® Foam, betamethasone dipropionate in the same vehicle, or calcipotriene in the same vehicle. In Trial Two, 426 subjects were randomized to one of two treatment groups: Enstilar Foam or the vehicle alone. Baseline disease severity was graded using a 5-point Investigator's Global Assessment (IGA). At baseline subjects scored "Mild", "Moderate", or "Severe". The majority of subjects in both trials (76% and 75%) ha...

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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial...

None. None. ( 4 )

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 hypothalam...