Sorilux

Calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. Calcipotriene foam, is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. ( 1 )

Calcipotriene 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 )

5.1Flammability

The propellant in calcipotriene foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

5.2Effects on Calcium Metabolism Elevation

of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

8.1Pregnancy Risk Summary

Although there are no available data on the drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene foam, systemic exposure to calcipotriene is likely to be low [see Clinical Pharmacology (12.2 , 12.3) ] . In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits (see Data ) .