SORILUX

The systemic absorption of calcipotriene in subjects with psoriasis of the body was evaluated at steady state following application of either SORILUX Foam or calcipotriene ointment to a body surface area of 5% to 10%. In the SORILUX Foam treatment group, 15 out of 16 subjects had calcipotriene plasma concentrations below the limit of quantitation (10 pg/mL), while in the calcipotriene ointment treated group, 5 out of 16 subjects had measurable calcipotriene plasma concentrations at various time ...

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. SORILUX Foam was studied in four vehicle-controlled trials. A total of 1094 adult subjects with plaque psoriasis, including 654 exposed to SORILUX Foam, were treated twice daily for 8 weeks. Adverse reactions reported in ≥1% of subjects treated with SORILUX Foam and at a higher incidence than subj...

Adverse reactions reported in ≥ 1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . ( 6 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug ca...

SORILUX Foam should not be used by patients with known hypercalcemia. Do not use in patients with known hypercalcemia. ( 4 )

Flammability: Contents are flammable. Instruct the patient the avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) Effects on Calcium Metabolism: If elevation of serum calcium occurs, instruct patients to discontinue treatment until normal calcium levels are restored. ( 5.2 ) 5.1 Flammability The propellant in SORILUX Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. 5.2 Effects on Calcium Meta...