SORILUX® (calcipotriene) Foam, 0.005%
Sorilux contains calcipotriene, a synthetic vitamin D3 analogue. It is indicated for the topical treatment of plaque psoriasis in patients aged 12 years and older. Plaque psoriasis is a chronic, non-contagious, inflammatory skin condition that appears as red patches covered with silvery flakes often found on the elbows, scalp and knees but can also affect other parts of the body.
Important Safety Information about Sorilux® (calcipotriene) Foam
The propellant in Sorilux Foam is ﬂammable. Instruct the patient to avoid ﬁre, ﬂame, and smoking during and immediately following application. Sorilux Foam should be used during pregnancy only if the potential beneﬁt justiﬁes the potential risk to the fetus. It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sorilux Foam is administered to a nursing woman. Safety and effectiveness of Sorilux Foam in pediatric patients less than 12 years of age have not been established. Sorilux Foam has not been evaluated in patients with erythrodermic, exfoliative, or pustular psoriasis. Sorilux Foam is not for oral, ophthalmic, or intravaginal use.
For additional safety and other information, please see Prescribing Information
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.