ication 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 sorilux 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 sorilux 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 sorilux 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

ated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data embryofetal development studies were conducted with calcipotriene after oral administration in rats and rabbits. pregnant rats received daily oral administration of calcipotriene during the period of organogenesis. fetuses from dams dosed with 54 mcg/kg/day (318 mcg/m 2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. the enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. there were no effects on the incidence of major malformations in fetuses. pregnant rabbits received daily oral administration of calcipotriene during the period of organogenesis. increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m 2 /day). fetuses from does dosed with 36 mcg/kg/day (396 mcg/m 2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities including incomplete ossification of pubic bones and forelimb phalanges. there were no effects on the incidence of major malformations in fetuses. 8.2 lactation risk summary there are no data on the presence of topically administered calcipotriene in human or animal milk, the effects on the breastfed infant, or the effects on milk production. after topical administration of sorilux foam, concentrations of calcipotriene in plasma are low, and therefore, concentrations in human milk are likely to be low [see clinical pharmacology (12.3) ] . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for and any potential adverse effects on the breastfed child from sorilux foam or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of sorilux foam have been established in pediatric patients age 4 years and older for topical treatment of plaque psoriasis of the scalp and body. use of sorilux foam in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years of age and older, with additional data from a 15-day open-label safety and pharmacokinetics (pk) study conducted in 19 subjects 12 to less than 17 years of age; and an 8-week open-label safety and pk study in 36 subjects 4 to 11 years of age with psoriasis. data from 19 subjects aged 12 to less than 17 years and 18 subjects aged 5 to 11 years showed no significant effects on indices of calcium metabolism. systemic concentrations of calcipotriene were not quantifiable in the two studies in subjects aged 7 years to less than 17 years. [see clinical studies (14) , clinical pharmacology (12.2 , 12.3) and adverse reactions (6.1) ] . the safety and effectiveness of sorilux foam in pediatric patients less than 4 years of age have not been established. 8.5 geriatric use clinical trials of sorilux foam did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data embryofetal development studies were conducted with calcipotriene after oral administration in rats and rabbits. pregnant rats received daily oral administration of calcipotriene during the period of organogenesis. fetuses from dams dosed with 54 mcg/kg/day (318 mcg/m 2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. the enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. there were no effects on the incidence of major malformations in fetuses. pregnant rabbits received daily oral administration of calcipotriene during the period of organogenesis. increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m 2 /day). fetuses from does dosed with 36 mcg/kg/day (396 mcg/m 2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities including incomplete ossification of pubic bones and forelimb phalanges. there were no effects on the incidence of major malformations in fetuses.

rilux foam in pediatric patients less than 4 years of age have not been established.

s no relationship between urinary calcium/creatinine ratio (comparing week 2 to baseline) and % bsa treated. 12.3 pharmacokinetics 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 points. all measurable plasma calcipotriene concentrations were below 25 pg/ml. the pharmacokinetics of sorilux foam, 0.005% was investigated when applied topically for 15 days to 17 subjects aged 12 to less than 17 years with moderate plaque psoriasis involving a mean bsa of 24%, excluding face and scalp, and a mean scalp involvement of 43%. systemic concentration of calcipotriene were not quantifiable in any of the subjects (limit of quantification = 10 pg/ml). in 11 pediatric subjects 7 to 11 years of age with plaque psoriasis involving a mean bsa of 10%, plasma concentration of calcipotriene was measured following 2 weeks of twice daily administration of sorilux foam. no subject had quantifiable calcipotriene plasma concentration (limit of quantification = 10 pg/ml). the systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin d. absorbed calcipotriene is known to be converted to inactive metabolites within 24 hours of application and the metabolism occurs via a similar pathway to the natural hormone.

atric subjects 7 to 11 years of age with plaque psoriasis involving a mean bsa of 10%, plasma concentration of calcipotriene was measured following 2 weeks of twice daily administration of sorilux foam. no subject had quantifiable calcipotriene plasma concentration (limit of quantification = 10 pg/ml). the systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin d. absorbed calcipotriene is known to be converted to inactive metabolites within 24 hours of application and the metabolism occurs via a similar pathway to the natural hormone.

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 sorilux 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) ] .

ned as a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score. approximately 30% of enrolled subjects were graded as "mild" on the isga scale. the study population ranged in age from 12 to 89 years with 10 subjects less than 18 years of age at baseline. the subjects were 54% male and 88% caucasian. table 2 presents the efficacy results for each trial. table 2. number and percent of subjects achieving success for body at week 8 in each trial trial 1 trial 2 sorilux foam n = 223 vehicle foam n = 113 sorilux foam n = 214 vehicle foam n = 109 number (%) of subjects with treatment success 31 (14%) 8 (7%) 58 (27%) 17 (16%) in one trial, subjects graded as "mild" at baseline showed a greater response to vehicle than sorilux foam. table 3 presents the success rates by disease severity at baseline for each trial. table 3. number and percent of subjects achieving success for body by baseline isga score and by trial trial 1 trial 2 isga scores at baseline sorilux foam (n = 223) vehicle foam (n = 113) sorilux foam (n = 214) vehicle foam (n = 109) mild 2/73 (2.7%) 3/34 (8.8%) 8/56 (14.3%) 4/31 (12.9%) moderate 29/150 (19.3%) 5/79 (6.3%) 50/158 (31.6%) 13/78 (16.7%) in another multi-center, randomized, double-blind, vehicle-controlled clinical trial, a total of 363 subjects with moderate plaque psoriasis of the scalp and body were randomized 1:1 to sorilux foam or vehicle. subjects applied the assigned treatment to the affected areas twice daily for 8 weeks. baseline disease severity of the scalp was graded using a 6-point isga; a score of "moderate" corresponded to grade 3. the primary efficacy evaluation for scalp involvement was carried out at week 8 with treatment success being defined as a score of "clear" (grade 0) or "almost clear" (grade 1). the study population ranged in age from 12 to 97 years with 11 subjects less than 18 years of age at baseline. the subjects were 60% male and 87% caucasian. table 4 presents the efficacy results for the trial. table 4. number and percent of subjects achieving success for scalp at week 8 trial 3 sorilux foam n = 181 vehicle foam n = 182 number (%) of subjects with treatment success 74 (41%) 44 (24%) the contribution to efficacy of individual components of the vehicle has not been established.

east milk. talk to your healthcare provider about the best way to feed your baby during treatment with sorilux foam. tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. know the medicines you take. keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. how should i use sorilux foam? use sorilux foam exactly as your healthcare provider tells you to use it. see the detailed " instructions for use " at the end of this leaflet for directions about how to apply sorilux foam the right away. sorilux foam is usually applied to the affected skin areas 2 times each day. for your scalp, apply sorilux foam when your hair is dry. talk with your healthcare provider if your skin does not improve after 8 weeks of treatment with sorilux foam. wash your hands after applying sorilux foam unless you are using the medicine to treat your hands. what should i avoid while using sorilux foam? sorilux foam is flammable . avoid fire, flame, and smoking during and right after you apply sorilux foam. avoid getting sorilux foam on your face or in or near your eyes. if sorilux foam gets on your face or in your eyes, rinse well with water. what are the possible side effects of sorilux foam? sorilux foam may cause serious side effects, including: too much calcium in your blood. your healthcare provider may tell you to stop using sorilux foam until your calcium levels become normal. the most common side effects of sorilux foam include redness and pain of the treated skin areas. these are not all the possible side effects of sorilux foam. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. you may also report side effects to mayne pharma at 1-844-825-8500. how should i store sorilux foam? store sorilux foam at room temperature, between 68°f to 77°f (20c° to 25°c). do not store sorilux foam in the refrigerator or freezer. do not expose sorilux foam to heat or store at temperatures above 120°f (49°c). do not puncture or burn the sorilux foam can. keep sorilux foam and all medicines out of the reach of children. general information about the safe and effective use of sorilux foam. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use sorilux foam for a condition for which it was not prescribed. do not give sorilux foam to other people even if they have the same symptoms you have. it may harm them. you can ask your healthcare provider or pharmacist for information about sorilux foam that is written for health professionals. what are the ingredients in sorilux foam? active ingredient: calcipotriene inactive ingredients: cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. the foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant. distributed by: mayne pharma greenville, nc 27834 sorilux is a registered trademark of mayne pharma llc.