calcipotriene

5 WARNINGS AND PRECAUTIONS 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 calcipotriene foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. 5.2 Effects 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.

6 ADVERSE REACTIONS Adverse reactions reported in ≥ 1% of subjects treated with Calcipotriene 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 cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Calcipotriene foam was studied in four vehicle-controlled trials. A total of 1094 adult subjects with plaque psoriasis, including 654 exposed to calcipotriene foam, were treated twice daily for 8 weeks. Adverse reactions reported in ≥1% of subjects treated with calcipotriene foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp. In an open-label study, 19 pediatric subjects age 12 to less than 17 years applied calcipotriene foam twice daily for 14 days and once on Day 15. Adverse reactions included application site pain, application site pruritus and pruritus [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] . In an open-label study, 36 pediatric subjects age 4 to less than 12 years applied calcipotriene foam twice daily for up to 8 weeks. Adverse reactions included application site pain and contact dermatitis [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] . 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of calcipotriene foam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous: application site vesicles