an ophthalmologist for evaluation. ( 5.3 ) initiate appropriate therapy if concomitant skin infections develop. ( 5.4 ) flammable contents. avoid heat, flame, or smoking during and immediately following application. ( 5.6 ) 5.1 hypothalamic-pituitary-adrenal (hpa) axis suppression and other adverse endocrine effects lexette is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (hpa) axis. systemic effects of topical corticosteroids may include reversible hpa axis suppression, with the potential for glucocorticosteroid insufficiency. this may occur during treatment or upon withdrawal of treatment of the topical corticosteroid. the potential for hypothalamic-pituitary adrenal (hpa) suppression with lexette was evaluated in the following studies: in a study of 25 adult subjects with moderate to severe plaque psoriasis involving ≥15% of their body surface area. lexette produced laboratory evidence of hpa axis suppression when used twice daily for two weeks in 6 out of 25 (24%) adult subjects with plaque psoriasis. all subjects returned to normal hpa axis function at follow-up at least 4 weeks after stopping the treatment [see clinical pharmacology (12.2) ]. in another clinical study, 24 subjects 12 to less than 18 years old with stable plaque psoriasis involving 10% or more of their body surface area applied lexette to affected areas twice daily for two weeks. of the 23 subjects evaluated for hpa axis suppression, laboratory evidence of adrenal suppression occurred in 6 subjects (26.1%), whom recovered upon retesting after at least 4 weeks of stopping the treatment [see clinical pharmacology (12.2) ] . because of the potential for systemic absorption, use of topical corticosteroids, including lexette, may require that patients be evaluated periodically for evidence of hpa axis suppression. factors that predispose a patient using a topical corticosteroid to hpa axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. an acth stimulation test may be helpful in evaluating patients for hpa axis suppression. if hpa axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. recovery of hpa axis function is generally prompt and complete upon discontinuation of topical corticosteroids. systemic effects of topical corticosteroids may also include cushing's syndrome, hyperglycemia, and glucosuria. use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids. pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios [see use in specific populations (8.4) ]. 5.2 local adverse reactions local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. these may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including lexette. some local adverse reactions may be irreversible. 5.3 ophthalmic adverse reactions use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products. advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.4 concomitant skin infections use an appropriate antimicrobial agent if a skin infection is present or develops. if a favorable response does not occur promptly, discontinue use of lexette until the infection has been adequately treated. 5.5 allergic contact dermatitis allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. discontinue lexette if allergic contact dermatitis is established. 5.6 flammability lexette is flammable. avoid fire, flame, or smoking during and immediately following application.

when control is achieved. ( 2 ) if no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) treatment beyond 2 consecutive weeks is not recommended. ( 2 ) do not use with occlusive dressings unless directed by a physician. ( 2 ) avoid use on the face, groin, or axillae. ( 2 ) lexette is not for ophthalmic, oral, or intravaginal use. ( 2 )

(up to approximately 50 grams per week). table 1 presents selected adverse reactions that occurred in at least 1% of subjects. table 1: adverse reactions occurring in ≥ 1% of subjects through week 2 hbp foam n=351 vehicle foam n=353 adverse reaction % % application site burning/stinging 12% 15% application site pain 1% <1% headache 1% <1% skin atrophy (n=1) and telangiectasia (n=2) were reported with lexette, but not with vehicle foam. 6.2 postmarketing experience because the 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. the following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.

in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. however, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. animal data halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. halobetasol propionate was embryotoxic in rabbits, but not in rats. cleft palate was observed in both rats and rabbits. omphalocele was seen in rats, but not in rabbits. 8.2 lactation risk summary there are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lexette and any potential adverse effects on the breastfed infant from lexette or from the underlying maternal condition. clinical considerations advise breastfeeding women not to apply lexette directly to the nipple and/or areola to avoid direct infant exposure. 8.4 pediatric use the safety and effectiveness of lexette in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. the safety and effectiveness of lexette for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with lexette. hypothalamic-pituitary adrenal (hpa) axis function (acth stimulation test) was evaluated in a subset of 23 subjects. after 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 µg/dl) that recovered upon retesting after at least 4 weeks of stopping the treatment [see clinical pharmacology (12.2) ]. because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing's syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see warnings and precautions (5.1) ]. hpa axis suppression, cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see warnings and precautions (5.1) ]. 8.5 geriatric use clinical studies with lexette included 131 subjects aged 65 years and over. no overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years.

nancies is 2-4% and 15-20%, respectively. data human data multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. however, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. animal data halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. halobetasol propionate was embryotoxic in rabbits, but not in rats. cleft palate was observed in both rats and rabbits. omphalocele was seen in rats, but not in rabbits.

opping the treatment [see clinical pharmacology (12.2) ]. because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing's syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see warnings and precautions (5.1) ]. hpa axis suppression, cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see warnings and precautions (5.1) ].

severe plaque psoriasis involving a mean body surface area of 18.4%. a mean dose of 3.7 g of lexette was applied twice daily for two weeks and produced laboratory evidence of hpa axis suppression in 6 of 25 (24%) subjects. all subjects returned to normal hpa axis function at follow-up at least 4 weeks after stopping the treatment. in the second study, lexette was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with a mean percent bsa of 15.1% (range of 11% to 23%). the mean dose of lexette used was 3.1 grams, which was applied twice daily for two weeks. in the study, 24 subjects completed the study, and 23 subjects had evaluable acth stimulation tests. hpa axis suppression was observed in 6 of the 23 subjects (26.1%), and all subjects returned to normal hpa axis function at follow-up at least 4 weeks after stopping the treatment. 12.3 pharmacokinetics the extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. topical corticosteroids can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin may increase percutaneous absorption. in the hpa-axis and pharmacokinetic study, as described above in clinical pharmacology (12.2) , pharmacokinetics was evaluated in a subgroup of 23 adult subjects with moderate to severe plaque psoriasis following twice daily treatment for 14 days. plasma concentration of halobetasol propionate (hbp) was measurable in all subjects and steady state was achieved by day 14. the mean (± standard deviation) c max concentration for hbp on day 14 was 199.7 ± 217.3 pg/ml, with the corresponding median t max value of 1 hour (range 0 – 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (auc t ) was 1434.9 ± 1310.6 pg∙h/ml. in the hpa axis study in subjects 12 to less than 18 years [see clinical pharmacology (12.2) ] , trough plasma concentrations of hbp were measured on day 8 and day 15 in 23 subjects following twice daily treatment for 14 days. on day 8, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate in plasma that were above the quantifiable limit (≥20.0 pg/ml); mean halobetasol concentration was 154.6 ± 308.67 pg/ml. similarly, on day 15, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate above the quantifiable limit; mean halobetasol concentration was 59.9 ± 90.15 pg/ml. of the 9 subjects with quantifiable plasma concentrations at day 15, seven (7) also had quantifiable plasma concentrations at day 8.

rve over the dosing interval (auc t ) was 1434.9 ± 1310.6 pg∙h/ml. in the hpa axis study in subjects 12 to less than 18 years [see clinical pharmacology (12.2) ] , trough plasma concentrations of hbp were measured on day 8 and day 15 in 23 subjects following twice daily treatment for 14 days. on day 8, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate in plasma that were above the quantifiable limit (≥20.0 pg/ml); mean halobetasol concentration was 154.6 ± 308.67 pg/ml. similarly, on day 15, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate above the quantifiable limit; mean halobetasol concentration was 59.9 ± 90.15 pg/ml. of the 9 subjects with quantifiable plasma concentrations at day 15, seven (7) also had quantifiable plasma concentrations at day 8.

assay, in the chinese hamster cho/hgprt assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the chinese hamster, or in the chromosome aberration test in somatic cells of chinese hamsters. positive mutagenicity effects were observed in two genotoxicity assays: chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

ster cho/hgprt assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the chinese hamster, or in the chromosome aberration test in somatic cells of chinese hamsters. positive mutagenicity effects were observed in two genotoxicity assays: chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

or the individual signs of psoriasis (plaque elevation, scaling, and erythema) at the end of treatment. table 2 presents these results. table 2: efficacy results at week 2 in subjects with plaque psoriasis study 1 study 2 lexette n=75 vehicle foam n=76 lexette n=205 vehicle foam n=204 overall treatment success subjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two-grade improvement from baseline based on the iga. 19 (25%) 3 (4%) 63 (31%) 15 (7%) plaque elevation subjects who were cleared or almost cleared of the designated clinical sign with at least a two-grade improvement from baseline. individual signs were rated by severity using a five-point scale ranging from 0 (clear) to 4 (severe). subjects with baseline value of 0 or 1 were excluded. 20/75 (27%) 3/76 (4%) 71/202 (35%) 20/203 (10%) scaling 21/75 (28%) 4/76 (5%) 68/201 (34%) 20/204 (10%) erythema 16/75 (21%) 2/76 (3%) 59/205 (29%) 17/204 (8%)

d immediately following application of this product.

astfeeding or plan to breastfeed. it is not known if lexette passes into your breast milk. if you use lexette and breastfeed, do not apply lexette to your nipple or areola to avoid getting lexette into your baby's mouth. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. especially tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection, or use other products on your skin that contain corticosteroid. how should i use lexette? see the " instructions for use " for detailed information about the right way to apply lexette. use lexette exactly as your healthcare provider tells you to use it. apply a thin layer of lexette to the affected skin areas 2 times each day. you should not use more than 50 grams of lexette in 1 week. avoid using lexette on your face, underarms (armpits), or groin areas. do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with lexette. do not use lexette longer than 2 continuous weeks unless advised to do so by your prescriber. wash your hands after using lexette unless you are using the medicine to treat your hands. what should i avoid while using lexette? lexette is flammable . avoid heat, flame, or smoking during and right after applying lexette to your skin. what are the possible side effects of lexette? lexette may cause serious side effects, including: lexette can pass through your skin . too much lexette passing through your skin can cause adrenal glands to stop working. cushing's syndrome , a condition that happens when your body is exposed to too much of the hormone cortisol. high blood sugar (hyperglycemia). vision problems . lexette may increase your chance of developing cataract(s) and glaucoma. tell your healthcare provider if you develop blurred vision or other vision problems during treatment with lexette. skin reactions at the treated skin site . tell your healthcare provider if you get any skin reactions or skin infections. effects on growth and weight in children . your healthcare provider may do certain blood tests to check for side effects. the most common side effect of lexette is mild to moderate pain at the treated site. these are not all of the possible side effects of lexette. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store lexette? store lexette at room temperature between 68°f to 77°f (20°c to 25°c). do not puncture or burn lexette can. do not store lexette next to heat or store at temperatures above120°f (49°c). do not freeze lexette. keep lexette and all medicines out of the reach of children. general information about the safe and effective use of lexette. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use lexette for a condition for which it was not prescribed. do not give lexette to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about lexette that is written for health professionals. what are the ingredients in lexette? active ingredient: halobetasol propionate inactive ingredients: alcohol (specially denatured alcohol [sda]), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water. lexette is dispensed from an aluminum can pressurized with a hydrocarbon propellant containing isobutane and propane. distributed by: mayne pharma greenville, nc 27834 u.s. patent 10,857,159 and 11,020,407 for more information call: 1-844-825-8500