INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE OLUX Foam is corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.. OLUX Foam is corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. (1).

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling:oEffects on Endocrine System [see Warnings and Precautions (5.1)]oOphthalmic Adverse Reactions [see Warnings and Precautions (5.2)]. oEffects on Endocrine System [see Warnings and Precautions (5.1)]. oOphthalmic Adverse Reactions [see Warnings and Precautions (5.2)]. Most common adverse reactions (>= 4%) are application site burning and other application site reactions. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.In controlled clinical trial involving 188 subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the subjects treated with OLUX Foam. In controlled clinical trials with OLUX Foam in 360 subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the subjects treated with OLUX Foam included application site burning (10%), application site dryness (<1%), and other application site reactions (4%).In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Local adverse reactions to topical corticosteroids may include: striae, itching, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. Ophthalmic adverse reactions may include: cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

GERIATRIC USE SECTION.

8.5 Geriatric Use Clinical studies of OLUX Foam did not include sufficient numbers of subjects aged 65 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1How Supplied Olux (clobetasol propionate) Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white aerosol foam is available as follows:NDC 0378-8182-5050 aluminum canNDC 0378-8182-01100 aluminum can. 16.2Storage and Handling Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120F (49C).Keep out of reach of children.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of OLUX Foam or clobetasol propionate. In 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from 0.001% to 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol propionate resulted in toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. no observable adverse effect level could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis. Clobetasol propionate was nonmutagenic in the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli WP2 fluctuation test. In the in vivo mouse micronucleus test, positive finding was observed at 24 hours, but not at 48 hours, following oral administration at dose of 2,000 mg/kg.Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and decrease in the number of living fetuses at the highest dose.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.. 12.2 Pharmacodynamics In controlled pharmacokinetic trial, of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of therapy with OLUX Foam applied to at least 20% of involved body surface area. Of the 13 subjects studied, of with psoriasis was suppressed after 14 days and all of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with OLUX Foam (See Table below).Table 1. Subjects With Reversible HPA Axis Suppression at Any Time During TreatmentDermatosisOLUX FoamPsoriasis1 of 9Atopic DermatitisOLUX Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of OLUX Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended. of 4. 12.3 Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES 14.1Scalp Psoriasis A well-controlled clinical trial evaluated 188 subjects with moderate to severe scalp psoriasis. Subjects were treated twice daily for weeks with one of treatments: OLUX Foam, vehicle foam, commercially available clobetasol propionate solution (TEMOVATE(R) Scalp Application), or vehicle solution. The efficacy of OLUX Foam in treating scalp psoriasis at the end of the weeks treatment was superior to that of vehicle (foam and solution), and was comparable to that of TEMOVATE Scalp Application (Table 2).Table 2. Efficacy Results From Controlled Clinical Trial in Scalp PsoriasisOLUX Foamn (%)Vehicle Foamn (%)Total number of subjects 6231Subjects with treatment successDefined as composite of an Investigators Global Assessment of completely clear or almost clear, plaque thickness score of 0, an erythema score of or 1, and scaling score of or at endpoint, scored on severity scale of to 4. 39 (63)1 (3)Subjects with parameter Clear at endpoint (scalp psoriasis) Scaling Clear at endpoint 42 (68)3 (10) Erythema Clear at endpoint 27 (44)2 (6) Plaque Thickness Clear at endpoint 41 (66)3 (10). 14.2Non-scalp Psoriasis Another well-controlled clinical trial evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean body surface area at baseline was 6.7% with range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for weeks with OLUX Foam or vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of OLUX Foam in treating non-scalp psoriasis at the end of weeks treatment was superior to that of vehicle foam (Table 3). Table 3. Efficacy Results From Controlled Clinical Trial in Non-scalp PsoriasisOLUX Foamn (%)Vehicle Foamn (%)Total number of subjects 139140Subjects with treatment successDefined as composite of Physicians Static Global Assessment score of or 1, scaling score of or 1, an erythema score of or and plaque thickness score of 0, based on severity scale of to at endpoint. 39 (28)4 (3)Physicians Static Global Assessment -Clear or almost clear at endpoint 94 (68)30 (21)Scaling Clear or almost clear at endpoint 101 (73)42 (30)Erythema Clear or almost clear at endpoint 88 (63)35 (25)Plaque Thickness Clear at endpoint 44 (32)5 (4).

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS None.. oNone (4). oNone (4).

DESCRIPTION SECTION.

11 DESCRIPTION OLUX (clobetasol propionate) Foam, 0.05%, is white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has high degree of glucocorticoid activity and slight degree of mineralocorticoid activity. Clobetasol propionate is 21-chloro-9-fluoro-11ss,17-dihydroxy-16ss-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, molecular weight of 466.97.The following is the chemical structure:Clobetasol propionate is white or almost white crystalline powder, practically insoluble in water.Each gram of OLUX Foam contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with hydrocarbon (propane/butane) propellant.. Clobetasol Propionate Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION Apply thin layer of OLUX Foam to the affected skin areas twice daily. OLUX Foam is super-high-potency topical corticosteroid; therefore, limit treatment to consecutive weeks. Patients should not use greater than 50 grams per week or more than 21 capfuls per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Therapy should be discontinued when control is achieved. OLUX Foam should not be used with occlusive dressings unless directed by physician. OLUX Foam is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application.Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. oApply thin layer to the affected skin areas twice daily. (2) oLimit treatment to consecutive weeks. (2) oDo not use more than 50 grams per week or more than 21 capfuls per week. (2) oDiscontinue therapy when control is achieved. (2) oDo not use with occlusive dressings unless directed by physician. (2) oAvoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2) oApply thin layer to the affected skin areas twice daily. (2) oLimit treatment to consecutive weeks. (2) oDo not use more than 50 grams per week or more than 21 capfuls per week. (2) oDiscontinue therapy when control is achieved. (2) oDo not use with occlusive dressings unless directed by physician. (2) oAvoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2).

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS Olux (clobetasol propionate) Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. oFoam, 0.05% (3). oFoam, 0.05% (3).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use)Effects on Endocrine SystemOLUX Foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including OLUX Foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using OLUX Foam if surgery is contemplated [see Warnings and Precautions (5.1)]. Ophthalmic Adverse ReactionsAdvise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.2)].Local Adverse ReactionsReport any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use [see Warnings and Precautions (5.3)].PregnancyAdvise pregnant women of the potential risk to fetus and to use OLUX Foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1) ].LactationAdvise woman to use OLUX Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply OLUX Foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)]. Important Administration InstructionsInform patients of the following:oAvoid use of OLUX Foam on the face, underarms, or groin areas unless directed by the physician.oDo not occlude the treatment area with bandage or other covering, unless directed by the physician.oDiscontinue therapy when control is achieved. If no improvement is seen within weeks, contact the physician.oFor proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin.oLimit treatment to consecutive weeks. Use no more than 50 grams of OLUX Foam per week, or more than 21 capfuls per week.oAvoid use of OLUX Foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing.oThe product is flammable; avoid heat, flame, and smoking when applying this product.oDo not use other corticosteroid-containing products without first consulting with the physician.. oAvoid use of OLUX Foam on the face, underarms, or groin areas unless directed by the physician.. oDo not occlude the treatment area with bandage or other covering, unless directed by the physician.. oDiscontinue therapy when control is achieved. If no improvement is seen within weeks, contact the physician.. oFor proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin.. oLimit treatment to consecutive weeks. Use no more than 50 grams of OLUX Foam per week, or more than 21 capfuls per week.. oAvoid use of OLUX Foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing.. oThe product is flammable; avoid heat, flame, and smoking when applying this product.. oDo not use other corticosteroid-containing products without first consulting with the physician.

LACTATION SECTION.

8.2 Lactation Risk Summary. There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate 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 mothers clinical need for OLUX Foam and any potential adverse effects on the breastfed infant from OLUX Foam or from the underlying maternal condition.. Clinical Considerations. To minimize potential exposure to the breastfed infant via breast milk, use OLUX Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply OLUX Foam directly to the nipple and areola to avoid direct infant exposure.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of OLUX Foam or clobetasol propionate. In 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from 0.001% to 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol propionate resulted in toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. no observable adverse effect level could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis. Clobetasol propionate was nonmutagenic in the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli WP2 fluctuation test. In the in vivo mouse micronucleus test, positive finding was observed at 24 hours, but not at 48 hours, following oral administration at dose of 2,000 mg/kg.Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and decrease in the number of living fetuses at the highest dose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 0.05% NDC 0378-8182-50Olux(R) (clobetasolpropionate)Foam, 0.05%Rx only 50 gFor Topical Use OnlyNot for Ophthalmic, Oral,or Intravaginal UseInvert can and thenpress firmly todispense.Description: Olux(R) (clobetasolpropionate) Foam, 0.05%, contains0.5 mg of clobetasol propionate, USPper gram in thermolabilehydroethanolic foam vehicleconsisting of cetyl alcohol, citricacid, ethanol (60%), polysorbate 60,potassium citrate, propylene glycol,purified water, and stearyl alcoholpressurized with hydrocarbon(propane/butane) propellant.Usual Dosage: Use only asprescribed by your physician. Seeaccompanying prescribinginformation.Warning: FLAMMABLE. AVOIDFIRE, FLAME, OR SMOKINGDURING AND IMMEDIATELYFOLLOWING APPLICATION.Keep away from eyes. Keep thisand all medication out of thereach of children.Contents under pressure. Do notpuncture or incinerate container.Do not expose to heat or store attemperatures above 120F (49C).Store at 20 to 25C (68 to 77F).[See USP Controlled RoomTemperature.]CFC FREEDPT:8182:50:1C:R3117504-0518Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.For more information, call Mylan at1-877-446-3679 (1-877-4-INFO-RX)or visit olux.comMylan.com(C)2018 Delcor Asset Corporation,a Mylan CompanyOLUX is registered trademark of StiefelLaboratories, Inc., GSK Company, exclusivelylicensed to the Mylan Companies.. Inversion of Can Principal Display Panel. Olux Foam 0.05% Carton Label.

PEDIATRIC USE SECTION.

8.4 Pediatric Use Safety and effectiveness of OLUX Foam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic toxicity when they are treated with topical drugs. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids. Rare systemic toxicities such as Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients.Avoid use of OLUX Foam in the treatment of diaper dermatitis.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics In controlled pharmacokinetic trial, of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of therapy with OLUX Foam applied to at least 20% of involved body surface area. Of the 13 subjects studied, of with psoriasis was suppressed after 14 days and all of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with OLUX Foam (See Table below).Table 1. Subjects With Reversible HPA Axis Suppression at Any Time During TreatmentDermatosisOLUX FoamPsoriasis1 of 9Atopic DermatitisOLUX Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of OLUX Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended. of 4.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

PREGNANCY SECTION.

8.1 Pregnancy Risk Summary. There are no available data on OLUX Foam use in pregnant women to inform of drug-associated risk for adverse developmental outcomes.Published data report significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women of the potential risk to fetus and to use OLUX Foam on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 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 during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month (range, 12-170g) over long periods of time.. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities.In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

RECENT MAJOR CHANGES SECTION.

Warnings and Precautions, Ophthalmic Adverse Reactions (5.2) 04/2018.

RISKS.

Risk Summary. There are no available data on OLUX Foam use in pregnant women to inform of drug-associated risk for adverse developmental outcomes.Published data report significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women of the potential risk to fetus and to use OLUX Foam on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.

SPL PATIENT PACKAGE INSERT SECTION.

Patient Information OLUX(R) (O-lux)(clobetasol propionate) FoamImportant: OLUX Foam is for use on the skin only. Do not get OLUX Foam in your eyes, mouth, or vagina.What is OLUX FoamOLUX Foam is prescription corticosteroid medicine used in people 12 years of age and older for the treatment of: omoderate to severe plaque psoriasis of the scalp andomild to moderate plaque psoriasis of the skin except the face and areas where the skin may touch or rub together.It is not known if OLUX Foam is safe and effective in children under 12 years of age.OLUX Foam is not recommended in children under 12 years of age.Before using OLUX Foam, tell your healthcare provider about all of your medical conditions, including if you:ohave had irritation or other skin reaction to steroid medicine in the past.ohave skin infection. You may need medicine to treat the skin infection before using OLUX Foam.ohave diabetes.ohave adrenal gland problems.ohave liver problems.oplan to have surgery.oare pregnant or plan to become pregnant. It is not known if OLUX Foam will harm your unborn baby. If you use OLUX Foam during pregnancy, use OLUX Foam on the smallest area of skin and for the shortest time needed. oare breastfeeding or plan to breastfeed. It is not known if OLUX passes into your breast milk. If you use OLUX Foam while breastfeeding, use OLUX Foam on the smallest area of skin and for the shortest time needed. Do not apply OLUX Foam directly to the nipple and areola to avoid getting OLUX Foam into your babys mouth.Tell your healthcare provider about all the medicine you take including prescription or over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing corticosteroid medicine during treatment with OLUX Foam without talking to your healthcare provider first.How should use OLUX FoamSee the Instructions for Use for detailed information about the right way to apply OLUX Foam. oUse OLUX Foam exactly as your healthcare provider tells you to use it. oApply thin layer of OLUX Foam to the affected skin areas times each day.oAvoid using OLUX Foam on your face, underarms (armpits), groin area, or in areas with thinning skin (atrophy).oAvoid using OLUX Foam on skin in diaper area. oDo not bandage or cover your treated area unless your healthcare provider tells you to.oDo not use OLUX Foam for longer than weeks in row.oYou should not use more than 50 grams or 21 capfuls of OLUX Foam in week.oTalk to your healthcare provider if your skin or scalp does not improve after weeks of treatment with OLUX Foam.oWash your hands after using OLUX Foam.What should avoid while using OLUX FoamOLUX Foam is flammable. Avoid heat, flame, or smoking during and right after you apply OLUX Foam to your skin.What are the possible side effects of OLUX FoamOLUX Foam may cause serious side effects, including:oOLUX Foam can pass through your skin. Too much OLUX Foam passing through your skin can cause adrenal glands to stop working.oCushings syndrome, condition that happens when the body is exposed to too much of the hormone cortisol.oHigh blood sugar (hyperglycemia) oVision problems. OLUX Foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with OLUX Foam.oSkin reactions at the treated skin site. Tell your healthcare provider if you get any skin reactions or skin infections.oEffects on growth and weight in children.Your healthcare provider may do certain blood tests to check for side effects. The most common side effects of OLUX Foam include burning and skin reactions at the treated site. These are not all the possible side effects of OLUX Foam. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should store OLUX FoamoStore OLUX Foam at room temperature between 20 to 25C (68 to 77F). oDo not break through (puncture) the OLUX Foam can. oNever throw the can into fire, even if the can is empty.oDo not store OLUX Foam near heat or store at temperatures above 120F (49C).Keep OLUX Foam and all medicines out of the reach of children. General information about the safe and effective use of OLUX Foam.Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use OLUX Foam for condition for which it was not prescribed. Do not give OLUX Foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about OLUX Foam that is written for health professionals.What are the ingredients in OLUX FoamActive ingredient: clobetasol propionateInactive ingredients: cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with hydrocarbon (propane/butane) propellant. Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or visit www.olux.com. Instructions for UseOLUX(R) (O-lux)(clobetasol propionate) FoamImportant: OLUX Foam is for use on the skin only. Do not get OLUX Foam in your eyes, mouth or vagina. How to apply OLUX Foam:Figure AStep 1: Remove the cap and save for further use. Step 2: Before applying OLUX Foam for the first time, break the tiny plastic piece at the base of the cans rim by gently pushing back (away from the piece) on the nozzle.(see Figure A)Figure BStep 3: Turn the can upside down. Push the button to dispense small amount of OLUX Foam into the cap of the can, or on your affected skin area. (see Figure B) This amount should be no more than 1/2 capfuls, about the size of golf ball.oDo not dispense OLUX Foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.oIf your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.oIf the can seems warm or the foam seems runny, run the can under cold water.Figure Figure DStep 4: Using your fingertips, gently massage thin layer of OLUX Foam into the affected skin areas until the foam disappears. (see Figures and D)Figure EStep 5: If you are treating areas with hair, such as the scalp, move any hair away so that the foam can be applied directly to the affected areas. (see Figure E)oRepeat until the affected areas are treated.Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your healthcare provider right away.Figure FStep 6: Wash your hands after applying OLUX Foam.(see Figure F)oThrow away any of the unused medicine that you dispensed out of the can.This Instructions for Use has been approved by the U.S. Food and Drug Administration.For additional information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or visit www.olux.com.OLUX is registered trademark of Stiefel Laboratories, Inc., GSK Company, exclusively licensed to the Mylan Companies.(C)2018 Delcor Asset Corporation, Mylan CompanyManufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.Revised: 4/2018140969-0418DPT: CLOBFO: R2. omoderate to severe plaque psoriasis of the scalp and. omild to moderate plaque psoriasis of the skin except the face and areas where the skin may touch or rub together.. ohave had irritation or other skin reaction to steroid medicine in the past.. ohave skin infection. You may need medicine to treat the skin infection before using OLUX Foam.. ohave diabetes.. ohave adrenal gland problems.. ohave liver problems.. oplan to have surgery.. oare pregnant or plan to become pregnant. It is not known if OLUX Foam will harm your unborn baby. If you use OLUX Foam during pregnancy, use OLUX Foam on the smallest area of skin and for the shortest time needed. oare breastfeeding or plan to breastfeed. It is not known if OLUX passes into your breast milk. If you use OLUX Foam while breastfeeding, use OLUX Foam on the smallest area of skin and for the shortest time needed. Do not apply OLUX Foam directly to the nipple and areola to avoid getting OLUX Foam into your babys mouth.. oUse OLUX Foam exactly as your healthcare provider tells you to use it. oApply thin layer of OLUX Foam to the affected skin areas times each day.. oAvoid using OLUX Foam on your face, underarms (armpits), groin area, or in areas with thinning skin (atrophy).. oAvoid using OLUX Foam on skin in diaper area. oDo not bandage or cover your treated area unless your healthcare provider tells you to.. oDo not use OLUX Foam for longer than weeks in row.. oYou should not use more than 50 grams or 21 capfuls of OLUX Foam in week.. oTalk to your healthcare provider if your skin or scalp does not improve after weeks of treatment with OLUX Foam.. oWash your hands after using OLUX Foam.. oOLUX Foam can pass through your skin. Too much OLUX Foam passing through your skin can cause adrenal glands to stop working.. oCushings syndrome, condition that happens when the body is exposed to too much of the hormone cortisol.. oHigh blood sugar (hyperglycemia) oVision problems. OLUX Foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with OLUX Foam.. oSkin reactions at the treated skin site. Tell your healthcare provider if you get any skin reactions or skin infections.. oEffects on growth and weight in children.. oStore OLUX Foam at room temperature between 20 to 25C (68 to 77F). oDo not break through (puncture) the OLUX Foam can. oNever throw the can into fire, even if the can is empty.. oDo not store OLUX Foam near heat or store at temperatures above 120F (49C).. oDo not dispense OLUX Foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin.. oIf your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.. oIf the can seems warm or the foam seems runny, run the can under cold water.. oRepeat until the affected areas are treated.. oThrow away any of the unused medicine that you dispensed out of the can.. Instructions for Use Figure A. Instructions for Use Figure B. Instructions for Use Figure C. Instructions for Use Figure D. Instructions for Use Figure E. Instructions for Use Figure F.

SPL UNCLASSIFIED SECTION.

5.1 Effects on Endocrine System OLUX Foam can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.In trial evaluating the effects of OLUX Foam on the HPA axis, 13 subjects applied OLUX Foam to at least 20% of involved body surface area for 14 days. HPA axis suppression was identified in out of 13 subjects (38%) [see Clinical Pharmacology (12.2) ]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with less potent corticosteroid. Cushings syndrome and hyperglycemia may also occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary. There are no available data on OLUX Foam use in pregnant women to inform of drug-associated risk for adverse developmental outcomes.Published data report significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Advise pregnant women of the potential risk to fetus and to use OLUX Foam on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 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 during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month (range, 12-170g) over long periods of time.. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities.In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities. 8.2 Lactation Risk Summary. There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate 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 mothers clinical need for OLUX Foam and any potential adverse effects on the breastfed infant from OLUX Foam or from the underlying maternal condition.. Clinical Considerations. To minimize potential exposure to the breastfed infant via breast milk, use OLUX Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply OLUX Foam directly to the nipple and areola to avoid direct infant exposure. 8.4 Pediatric Use Safety and effectiveness of OLUX Foam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic toxicity when they are treated with topical drugs. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids. Rare systemic toxicities such as Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients.Avoid use of OLUX Foam in the treatment of diaper dermatitis.. 8.5 Geriatric Use Clinical studies of OLUX Foam did not include sufficient numbers of subjects aged 65 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS oOLUX Foam can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.1, 8.4) oOLUX Foam may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.2)oOLUX Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. (5.4). oOLUX Foam can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.1, 8.4) oOLUX Foam may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.2). oOLUX Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. (5.4). 5.1 Effects on Endocrine System OLUX Foam can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.In trial evaluating the effects of OLUX Foam on the HPA axis, 13 subjects applied OLUX Foam to at least 20% of involved body surface area for 14 days. HPA axis suppression was identified in out of 13 subjects (38%) [see Clinical Pharmacology (12.2) ]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with less potent corticosteroid. Cushings syndrome and hyperglycemia may also occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].. 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including OLUX Foam, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products. Avoid contact of OLUX Foam with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.. 5.3 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.. 5.4 Flammable Contents OLUX Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.