ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions are discussed in greater detail in other sections of the label:Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1)] Allergic Contact Dermatitis [see Warnings and Precautions (5.5)] Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1)] Allergic Contact Dermatitis [see Warnings and Precautions (5.5)] The most commonly reported adverse reactions (>=1%) are application site pain and headache. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.. 6.1Clinical 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 practice.In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with Halobetasol Propionate Topical Foam twice daily for up to two weeks (up to approximately 50 grams per week). Table presents selected adverse reactions that occurred in at least 1% of subjects.Table 1:Adverse Reactions Occurring in >= 1% of Subjects through Week 2HBP FoamN=351Vehicle FoamN=353Adverse Reaction%%Skin atrophy (n=1) and telangiectasia (n=2) were reported with Halobetasol Propionate Topical Foam, but not with vehicle foam. Application site burning/stinging12%15% Application site pain1%<1% Headache1%<1%. 6.2 Postmarketing Experience. Because the 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.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.

CLINICAL PHARMACOLOGY SECTION.

12CLINICAL PHARMACOLOGY. 12.1Mechanism of Action. Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.. 12.2Pharmacodynamics. Vasoconstrictor AssayA vasoconstrictor assay in healthy patients with Halobetasol Propionate Topical Foam indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.. Hypothalamic-pituitary adrenal (HPA) axis suppressionThe potential for hypothalamic-pituitary adrenal axis (HPA-axis) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH).In the first study, Halobetasol Propionate Topical Foam was applied to 25 adult subjects with moderate to severe plaque psoriasis involving mean body surface area of 18.4%. mean dose of 3.7 of Halobetasol Propionate Topical Foam was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in of 25 (24%) subjects. All subjects returned to normal HPA axis function at follow-up at least weeks after stopping the treatment.In the second study, Halobetasol Propionate Topical Foam was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with mean percent BSA of 15.1% (range of 11% to 23%). The mean dose of Halobetasol Propionate Topical Foam 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 of the 23 subjects (26.1%), and all subjects returned to normal HPA axis function at follow-up at least weeks after stopping the treatment.. 12.3Pharmacokinetics. 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 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) Cmax concentration for HBP on Day 14 was 199.7 +- 217.3 pg/mL, with the corresponding median Tmax value of hour (range - 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1434.9 +- 1310.6 pgh/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 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 subjects with quantifiable plasma concentrations at Day 15, seven (7) also had quantifiable plasma concentrations at Day 8.

CLINICAL STUDIES SECTION.

14CLINICAL STUDIES. Halobetasol Propionate Topical Foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled studies (Study [NCT02368210] and Study [NCT02742441]).These studies were conducted in 560 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using static, five-level Investigators Global Assessment (IGA) scale, on which subject scored either moderate or severe. Overall, approximately 60% of subjects were male and approximately 90% were Caucasian.Subjects applied Halobetasol Propionate Topical Foam or vehicle to all affected areas twice daily for up to 14 consecutive days.The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least two-grade improvement from baseline at Week (end of treatment) based on the IGA. The studies also evaluated treatment success for the individual signs of psoriasis (plaque elevation, scaling, and erythema) at the end of treatment. Table presents these results.Table 2:Efficacy Results at Week in Subjects with Plaque PsoriasisStudy 1Study 2HBP Foam N=75Vehicle Foam N=76HBP Foam N=205Vehicle Foam N=204Overall Treatment SuccessSubjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least two-grade improvement from baseline based on the IGA. 19 (25%)3 (4%)63 (31%)15 (7%)Plaque ElevationSubjects who were cleared or almost cleared of the designated clinical sign with at least two-grade improvement from baseline. Individual signs were rated by severity using five-point scale ranging from (clear) to (severe). Subjects with baseline value of or 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%).

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. Shake can prior to use. Apply Halobetasol Propionate Topical Foam as thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product.Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of the diagnosis may be necessary.Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Do not use with occlusive dressings unless directed by physician.Avoid use on the face, groin, or axillae.Avoid contact with eyes.Halobetasol Propionate Topical Foam is for topical use only.Halobetasol Propionate Topical Foam is not for ophthalmic, oral, or intravaginal use.. Shake before use. (2)Apply Halobetasol Propionate Topical Foam as thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. (2)Do not use more than 50 grams per week. (2)Discontinue Halobetasol Propionate Topical Foam when control is achieved. (2)If no improvement is seen within weeks, reassess diagnosis. (2)Treatment beyond consecutive weeks is not recommended. (2)Do not use with occlusive dressings unless directed by physician. (2)Avoid use on the face, groin, or axillae. (2)Halobetasol Propionate Topical Foam is not for ophthalmic, oral, or intravaginal use. (2). Shake before use. (2). Apply Halobetasol Propionate Topical Foam as thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. (2). Do not use more than 50 grams per week. (2). Discontinue Halobetasol Propionate Topical Foam when control is achieved. (2). If no improvement is seen within weeks, reassess diagnosis. (2). Treatment beyond consecutive weeks is not recommended. (2). Do not use with occlusive dressings unless directed by physician. (2). Avoid use on the face, groin, or axillae. (2). Halobetasol Propionate Topical Foam is not for ophthalmic, oral, or intravaginal use. (2).

PEDIATRIC USE SECTION.

8.4Pediatric Use. The safety and effectiveness of Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam 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 minimum of 10% of the total body surface area at baseline were treated twice daily for weeks with Halobetasol Propionate Topical Foam. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in subset of 23 subjects. After weeks of treatment, of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of <=18 ug/dL) that recovered upon retesting after at least weeks of stopping the treatment [see Clinical Pharmacology (12.2)].Because of higher skin surface area to body mass ratios, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings 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, Cushings 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)].

INFORMATION FOR PATIENTS SECTION.

17PATIENT COUNSELING INFORMATION. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).This information is intended to aid in the safe and effective use of this medication. It is not disclosure of all administration instructions or all possible adverse or unintended effects.Inform patients of the following:. Important Administration Instructions:Total dosage should not exceed 50 grams (one can) per week [see Dosage and Administration (2)].Advise patients to avoid use on the face, groin, or axillae. Avoid contact with eyes [see Dosage and Administration (2)].Inform patients that topical corticosteroids may cause HPA axis suppression and local adverse reactions [see Warnings and Precautions (5.1)].Breastfeeding women should not apply Halobetasol Propionate Topical Foam directly to the nipple and/or areola to avoid direct exposure to the infant [see Use in Specific Populations (8.2)].This product is flammable; avoid heat, flame, or smoking during and immediately following application of this product.. Total dosage should not exceed 50 grams (one can) per week [see Dosage and Administration (2)].. Advise patients to avoid use on the face, groin, or axillae. Avoid contact with eyes [see Dosage and Administration (2)].. Inform patients that topical corticosteroids may cause HPA axis suppression and local adverse reactions [see Warnings and Precautions (5.1)].. Breastfeeding women should not apply Halobetasol Propionate Topical Foam directly to the nipple and/or areola to avoid direct exposure to the infant [see Use in Specific Populations (8.2)].. This product is flammable; avoid heat, flame, or smoking during and immediately following application of this product.

PHARMACODYNAMICS SECTION.

12.2Pharmacodynamics. Vasoconstrictor AssayA vasoconstrictor assay in healthy patients with Halobetasol Propionate Topical Foam indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.. Hypothalamic-pituitary adrenal (HPA) axis suppressionThe potential for hypothalamic-pituitary adrenal axis (HPA-axis) suppression was evaluated in the following two studies. In both studies, the criteria for HPA-axis suppression was serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone, ACTH).In the first study, Halobetasol Propionate Topical Foam was applied to 25 adult subjects with moderate to severe plaque psoriasis involving mean body surface area of 18.4%. mean dose of 3.7 of Halobetasol Propionate Topical Foam was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in of 25 (24%) subjects. All subjects returned to normal HPA axis function at follow-up at least weeks after stopping the treatment.In the second study, Halobetasol Propionate Topical Foam was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with mean percent BSA of 15.1% (range of 11% to 23%). The mean dose of Halobetasol Propionate Topical Foam 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 of the 23 subjects (26.1%), and all subjects returned to normal HPA axis function at follow-up at least weeks after stopping the treatment.

PHARMACOKINETICS SECTION.

12.3Pharmacokinetics. 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 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) Cmax concentration for HBP on Day 14 was 199.7 +- 217.3 pg/mL, with the corresponding median Tmax value of hour (range - 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1434.9 +- 1310.6 pgh/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 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 subjects with quantifiable plasma concentrations at Day 15, seven (7) also had quantifiable plasma concentrations at Day 8.

PREGNANCY SECTION.

8.1Pregnancy. Risk SummaryThere are no available data on Halobetasol Propionate Topical Foam use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of Halobetasol Propionate Topical Foam [see Clinical Pharmacology (12.3)].The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.. Data. Human DataMultiple 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.. Animal DataHalobetasol 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.

SPL PATIENT PACKAGE INSERT SECTION.

PATIENT INFORMATIONHALOBETASOL PROPIONATE (hal-oh-BAY-ta-sol PRO-pee-oh-nate) Topical Foam, 0.05%This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 05/2021Important: Halobetasol Propionate Topical Foam is for use on the skin only. Do not apply Halobetasol Propionate Topical Foam near or in your eyes, mouth, or vagina.What is Halobetasol Propionate Topical FoamHalobetasol Propionate Topical Foam is prescription corticosteroid medicine used on the skin to treat plaque psoriasis in people 12 years of age and older. It is not known if Halobetasol Propionate Topical Foam is safe and effective in children under 12 years of age.Before using Halobetasol Propionate Topical Foam, tell your healthcare provider about all of your medical conditions, including if you:have had irritation or other skin reaction to steroid medicine in the past.have skin infection. You may need medicine to treat the skin infection before using Halobetasol Propionate Topical Foam.have diabetes.have adrenal gland problems.have liver problems.plan to have surgery.are pregnant or plan to become pregnant. It is not known if Halobetasol Propionate Topical Foam will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if Halobetasol Propionate Topical Foam passes into your breast milk. If you use Halobetasol Propionate Topical Foam and breastfeed, do not apply Halobetasol Propionate Topical Foam to your nipple or areola to avoid getting Halobetasol Propionate Topical Foam into your babys 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 use Halobetasol Propionate Topical FoamSee the Instructions for Use for detailed information about the right way to apply Halobetasol Propionate Topical Foam.Use Halobetasol Propionate Topical Foam exactly as your healthcare provider tells you to use it.Apply thin layer of Halobetasol Propionate Topical Foam to the affected skin areas times each day.You should not use more than 50 grams of Halobetasol Propionate Topical Foam in week.Avoid using Halobetasol Propionate Topical Foam 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 weeks of treatment with Halobetasol Propionate Topical Foam.Do not use Halobetasol Propionate Topical Foam longer than continuous weeks unless advised to do so by your prescriber.Wash your hands after using Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.What should avoid while using Halobetasol Propionate Topical FoamHalobetasol Propionate Topical Foam is flammable. Avoid heat, flame, or smoking during and right after applying Halobetasol Propionate Topical Foam to your skin.What are the possible side effects of Halobetasol Propionate Topical FoamHalobetasol Propionate Topical Foam may cause serious side effects, including:Halobetasol Propionate Topical Foam can pass through your skin. Too much Halobetasol Propionate Topical Foam passing through your skin can cause adrenal glands to stop working.Cushings syndrome, condition that happens when your body is exposed to too much of the hormone cortisol.High blood sugar (hyperglycemia).Vision problems. Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam.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 Halobetasol Propionate Topical Foam is mild to moderate pain at the treated site.These are not all of the possible side effects of Halobetasol Propionate Topical Foam.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.How should store Halobetasol Propionate Topical FoamStore Halobetasol Propionate Topical Foam at room temperature between 68F to 77F (20C to 25C).Do not puncture or burn Halobetasol Propionate Topical Foam can.Do not store Halobetasol Propionate Topical Foam next to heat or store at temperatures above 120F (49C).Do not freeze Halobetasol Propionate Topical Foam.Keep Halobetasol Propionate Topical Foam and all medicines out of the reach of children.General information about the safe and effective use of Halobetasol Propionate Topical Foam. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use Halobetasol Propionate Topical Foam for condition for which it was not prescribed. Do not give Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam that is written for health professionals.What are the ingredients in Halobetasol Propionate Topical FoamActive ingredient: halobetasol propionateInactive ingredients: alcohol (specially denatured alcohol [SDA]), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water. Halobetasol Propionate Topical Foam is dispensed from an aluminum can pressurized with hydrocarbon propellant containing isobutane and propane.Distributed by: Mayne PharmaGreenville, NC 27834U.S. Patent 10,857,159 and 11,020,407For more information call: 1-844-825-8500. have had irritation or other skin reaction to steroid medicine in the past.. have skin infection. You may need medicine to treat the skin infection before using Halobetasol Propionate Topical Foam.. have diabetes.. have adrenal gland problems.. have liver problems.. plan to have surgery.. are pregnant or plan to become pregnant. It is not known if Halobetasol Propionate Topical Foam will harm your unborn baby.. are breastfeeding or plan to breastfeed. It is not known if Halobetasol Propionate Topical Foam passes into your breast milk. If you use Halobetasol Propionate Topical Foam and breastfeed, do not apply Halobetasol Propionate Topical Foam to your nipple or areola to avoid getting Halobetasol Propionate Topical Foam into your babys mouth.. Use Halobetasol Propionate Topical Foam exactly as your healthcare provider tells you to use it.. Apply thin layer of Halobetasol Propionate Topical Foam to the affected skin areas times each day.. You should not use more than 50 grams of Halobetasol Propionate Topical Foam in week.. Avoid using Halobetasol Propionate Topical Foam 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 weeks of treatment with Halobetasol Propionate Topical Foam.. Do not use Halobetasol Propionate Topical Foam longer than continuous weeks unless advised to do so by your prescriber.. Wash your hands after using Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.. Halobetasol Propionate Topical Foam can pass through your skin. Too much Halobetasol Propionate Topical Foam passing through your skin can cause adrenal glands to stop working.. Cushings syndrome, condition that happens when your body is exposed to too much of the hormone cortisol.. High blood sugar (hyperglycemia).. Vision problems. Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam.. 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.. Store Halobetasol Propionate Topical Foam at room temperature between 68F to 77F (20C to 25C).. Do not puncture or burn Halobetasol Propionate Topical Foam can.. Do not store Halobetasol Propionate Topical Foam next to heat or store at temperatures above 120F (49C).. Do not freeze Halobetasol Propionate Topical Foam.

SPL UNCLASSIFIED SECTION.

5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects. Halobetasol Propionate Topical Foam is 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 Halobetasol Propionate Topical Foam was evaluated in the following studies:In study of 25 adult subjects with moderate to severe plaque psoriasis involving >=15% of their body surface area. Halobetasol Propionate Topical Foam produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in out of 25 (24%) adult subjects with plaque psoriasis. All subjects returned to normal HPA axis function at follow-up at least 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 Halobetasol Propionate Topical Foam to affected areas twice daily for two weeks. Of the 23 subjects evaluated for HPA axis suppression, laboratory evidence of adrenal suppression occurred in subjects (26.1%), whom recovered upon retesting after at least weeks of stopping the treatment [see Clinical Pharmacology (12.2)]. Because of the potential for systemic absorption, use of topical corticosteroids, including Halobetasol Propionate Topical Foam, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose patient using 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 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 Cushings 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)].. In study of 25 adult subjects with moderate to severe plaque psoriasis involving >=15% of their body surface area. Halobetasol Propionate Topical Foam produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in out of 25 (24%) adult subjects with plaque psoriasis. All subjects returned to normal HPA axis function at follow-up at least 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 Halobetasol Propionate Topical Foam to affected areas twice daily for two weeks. Of the 23 subjects evaluated for HPA axis suppression, laboratory evidence of adrenal suppression occurred in subjects (26.1%), whom recovered upon retesting after at least weeks of stopping the treatment [see Clinical Pharmacology (12.2)].

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1Pregnancy. Risk SummaryThere are no available data on Halobetasol Propionate Topical Foam use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of Halobetasol Propionate Topical Foam [see Clinical Pharmacology (12.3)].The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.. Data. Human DataMultiple 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.. Animal DataHalobetasol 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.. 8.2Lactation. Risk SummaryThere 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 mothers clinical need for Halobetasol Propionate Topical Foam and any potential adverse effects on the breastfed infant from Halobetasol Propionate Topical Foam or from the underlying maternal condition.. Clinical ConsiderationsAdvise breastfeeding women not to apply Halobetasol Propionate Topical Foam directly to the nipple and/or areola to avoid direct infant exposure.. 8.4Pediatric Use. The safety and effectiveness of Halobetasol Propionate Topical Foam 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 Halobetasol Propionate Topical Foam 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 minimum of 10% of the total body surface area at baseline were treated twice daily for weeks with Halobetasol Propionate Topical Foam. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in subset of 23 subjects. After weeks of treatment, of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of <=18 ug/dL) that recovered upon retesting after at least weeks of stopping the treatment [see Clinical Pharmacology (12.2)].Because of higher skin surface area to body mass ratios, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings 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, Cushings 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)].. 8.5Geriatric Use. Clinical studies with Halobetasol Propionate Topical Foam 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.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic effects following prolonged exposure of topical corticosteroids may also include Cushings syndrome, hyperglycemia, and glucosuria. Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. (5.1)Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids. (5.2)Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to 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). Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic effects following prolonged exposure of topical corticosteroids may also include Cushings syndrome, hyperglycemia, and glucosuria. Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. (5.1). Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4). Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids. (5.2). Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to 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). 5.1Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects. Halobetasol Propionate Topical Foam is 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 Halobetasol Propionate Topical Foam was evaluated in the following studies:In study of 25 adult subjects with moderate to severe plaque psoriasis involving >=15% of their body surface area. Halobetasol Propionate Topical Foam produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in out of 25 (24%) adult subjects with plaque psoriasis. All subjects returned to normal HPA axis function at follow-up at least 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 Halobetasol Propionate Topical Foam to affected areas twice daily for two weeks. Of the 23 subjects evaluated for HPA axis suppression, laboratory evidence of adrenal suppression occurred in subjects (26.1%), whom recovered upon retesting after at least weeks of stopping the treatment [see Clinical Pharmacology (12.2)]. Because of the potential for systemic absorption, use of topical corticosteroids, including Halobetasol Propionate Topical Foam, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose patient using 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 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 Cushings 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)].. In study of 25 adult subjects with moderate to severe plaque psoriasis involving >=15% of their body surface area. Halobetasol Propionate Topical Foam produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in out of 25 (24%) adult subjects with plaque psoriasis. All subjects returned to normal HPA axis function at follow-up at least 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 Halobetasol Propionate Topical Foam to affected areas twice daily for two weeks. Of the 23 subjects evaluated for HPA axis suppression, laboratory evidence of adrenal suppression occurred in subjects (26.1%), whom recovered upon retesting after at least weeks of stopping the treatment [see Clinical Pharmacology (12.2)]. 5.2Local 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 Halobetasol Propionate Topical Foam. Some local adverse reactions may be irreversible.. 5.3Ophthalmic 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.. 5.4Concomitant Skin Infections. Use an appropriate antimicrobial agent if skin infection is present or develops. If favorable response does not occur promptly, discontinue use of Halobetasol Propionate Topical Foam until the infection has been adequately treated.. 5.5Allergic Contact Dermatitis. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation. Consider confirmation of clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue Halobetasol Propionate Topical Foam if allergic contact dermatitis is established.. 5.6Flammability. Halobetasol Propionate Topical Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.