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| Product NDC Code | 51862-604 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Lexette |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | AEROSOL, FOAM | ||||||
| RxCUI drug identifier | 2047646, 2106585 |
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| Application Number | NDA210566 | ||||||
| Labeler Name | Mayne Pharma | ||||||
| Packages |
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Overdosage of LEXETTE
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Topically applied LEXETTE can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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) ] 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a 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 LEXETTE twice daily for up to two weeks (up to approximately 50 grams per week). Table 1 presents selected adverse reactions that occurred in at least 1% of subjects. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects through Week 2 HBP Foam N=351 Vehicle Foam N=353 Adverse Reaction % % Application site burning/stinging 12% 15% Application site pain 1% <1% Headache 1% <1% Skin atrophy (n=1) and telangiectasia (n=2) were reported with LEXETTE, but not with vehicle foam. 6.2 Postmarketing Experience Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.
| HBP Foam N=351 | Vehicle Foam N=353 | |
|---|---|---|
| % | % | |
| Application site burning/stinging | 12% | 15% |
| Application site pain | 1% | <1% |
| Headache | 1% | <1% |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown. 12.2 Pharmacodynamics Vasoconstrictor Assay A vasoconstrictor assay in healthy patients with LEXETTE 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 suppression The 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 a 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, LEXETTE was applied to 25 adult subjects with moderate to severe plaque psoriasis involving a mean body surface area of 18.4%. A mean dose of 3.7 g of LEXETTE was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in 6 of 25 (24%) subjects. All subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment. In the second study, LEXETTE was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with a mean percent BSA of 15.1% (range of 11% to 23%). The mean dose of LEXETTE used was 3.1 grams, which was applied twice daily for two weeks. In the study, 24 subjects completed the study, and 23 subjects had evaluable ACTH stimulation tests. HPA axis suppression was observed in 6 of the 23 subjects (26.1%), and all subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment. 12.3 Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. In the HPA-axis and pharmacokinetic study, as described above in Clinical Pharmacology (12.2) , pharmacokinetics was evaluated in a subgroup of 23 adult subjects with moderate to severe plaque psoriasis following twice daily treatment for 14 days. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects and steady state was achieved by Day 14. The mean (± standard deviation) C max concentration for HBP on Day 14 was 199.7 ± 217.3 pg/mL, with the corresponding median T max value of 1 hour (range 0 – 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUC t ) was 1434.9 ± 1310.6 pg∙h/mL. In the HPA axis study in subjects 12 to less than 18 years [see Clinical Pharmacology (12.2) ] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in 23 subjects following twice daily treatment for 14 days. On Day 8, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate in plasma that were above the quantifiable limit (≥20.0 pg/mL); mean halobetasol concentration was 154.6 ± 308.67 pg/mL. Similarly, on Day 15, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate above the quantifiable limit; mean halobetasol concentration was 59.9 ± 90.15 pg/mL. Of the 9 subjects with quantifiable plasma concentrations at Day 15, seven (7) also had quantifiable plasma concentrations at Day 8.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Vasoconstrictor Assay A vasoconstrictor assay in healthy patients with LEXETTE 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 suppression The 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 a 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, LEXETTE was applied to 25 adult subjects with moderate to severe plaque psoriasis involving a mean body surface area of 18.4%. A mean dose of 3.7 g of LEXETTE was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in 6 of 25 (24%) subjects. All subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment. In the second study, LEXETTE was applied to 24 subjects 12 to less than 18 years of age with stable plaque psoriasis with a mean percent BSA of 15.1% (range of 11% to 23%). The mean dose of LEXETTE used was 3.1 grams, which was applied twice daily for two weeks. In the study, 24 subjects completed the study, and 23 subjects had evaluable ACTH stimulation tests. HPA axis suppression was observed in 6 of the 23 subjects (26.1%), and all subjects returned to normal HPA axis function at follow-up at least 4 weeks after stopping the treatment.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. In the HPA-axis and pharmacokinetic study, as described above in Clinical Pharmacology (12.2) , pharmacokinetics was evaluated in a subgroup of 23 adult subjects with moderate to severe plaque psoriasis following twice daily treatment for 14 days. Plasma concentration of halobetasol propionate (HBP) was measurable in all subjects and steady state was achieved by Day 14. The mean (± standard deviation) C max concentration for HBP on Day 14 was 199.7 ± 217.3 pg/mL, with the corresponding median T max value of 1 hour (range 0 – 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUC t ) was 1434.9 ± 1310.6 pg∙h/mL. In the HPA axis study in subjects 12 to less than 18 years [see Clinical Pharmacology (12.2) ] , trough plasma concentrations of HBP were measured on Day 8 and Day 15 in 23 subjects following twice daily treatment for 14 days. On Day 8, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate in plasma that were above the quantifiable limit (≥20.0 pg/mL); mean halobetasol concentration was 154.6 ± 308.67 pg/mL. Similarly, on Day 15, nine (9) of the 23 evaluable subjects had morning trough concentrations of halobetasol propionate above the quantifiable limit; mean halobetasol concentration was 59.9 ± 90.15 pg/mL. Of the 9 subjects with quantifiable plasma concentrations at Day 15, seven (7) also had quantifiable plasma concentrations at Day 8.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. None.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION LEXETTE is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate intended for topical use. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C 25 H 31 ClF 2 O 5 . It has the following structural formula: It is practically insoluble in water and freely soluble in dichloromethane and in acetone. Each gram of LEXETTE contains 0.5 mg of halobetasol propionate in a white to off-white foam base consisting of alcohol (specially denatured alcohol [SDA]), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol and purified water. LEXETTE is dispensed from an aluminum can pressurized with a hydrocarbon (isobutane and propane) propellant. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Shake can prior to use. Apply LEXETTE as a 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 a physician. Avoid use on the face, groin, or axillae. Avoid contact with eyes. LEXETTE is for topical use only. LEXETTE is not for ophthalmic, oral, or intravaginal use. Shake before use. ( 2 ) Apply LEXETTE as a 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 LEXETTE when control is achieved. ( 2 ) If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) Treatment beyond 2 consecutive weeks is not recommended. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, groin, or axillae. ( 2 ) LEXETTE is not for ophthalmic, oral, or intravaginal use. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS LEXETTE ® (halobetasol propionate) topical foam is a white to off-white topical foam. Each gram of LEXETTE, 0.05% contains 0.5 mg of halobetasol propionate. Topical foam: 0.05% (0.5 mg/g). ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE LEXETTE ® is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. LEXETTE is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.LEXETTE Halobetasol propionate Halobetasol propionate Halobetasol ALCOHOL Propylene Glycol POLAWAX POLYSORBATE Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol WATER Benzoic Acid
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of LEXETTE at dose concentrations from 0.005% to 0.05% or from 0.011 to 0.11 mg/kg/day of halobetasol propionate resulted in a 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. A 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 of carcinogenesis. Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. Studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of LEXETTE at dose concentrations from 0.005% to 0.05% or from 0.011 to 0.11 mg/kg/day of halobetasol propionate resulted in a 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. A 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 of carcinogenesis. Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro. Studies in the rat following oral administration at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 50 g Canister Carton NDC 51862-604-50 LEXETTE™ (halobetasol propionate) Topical Foam, 0.05% For topical use only. Rx ONLY Net Wt. 50 g 24976 mayne pharma PRINCIPAL DISPLAY PANEL - 50 g Canister Carton
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indication and Usage ( 1 ) 05/2021
| Indication and Usage ( | 05/2021 |
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only Distributed by: Mayne Pharma Raleigh, NC 27609 U.S. Patent 10,857,159 and 11,020,407 Revised: 03/2023
LEXETTE: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT 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 a 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 LEXETTE 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.
Instructions for use
Information about safe handling and use of the drug product.INSTRUCTIONS FOR USE LEXETTE ® (lex-et) (halobetasol propionate) Topical Foam, 0.05% Read the Patient Information and Instructions for Use before you use LEXETTE. Important information : LEXETTE is for skin use only. Do not get LEXETTE in your mouth, eyes, or vagina. Parts of the LEXETTE can: This Instructions for Use has been approved by the U.S. Food and Drug Administration. Step 1 : Before applying LEXETTE for the first time, remove cap and break the small tab at the base of the actuator by gently pushing the actuator away from the tab as shown. Do not break the hinge on the actuator. Step 2: Shake the can well before use. Step 3: Turn the can completely upside down. Step 4 : Press down on the actuator to dispense a small amount of the foam into the palm of your hand. Step 5 : Apply a thin layer of LEXETTE to the affected skin area. Gently rub LEXETTE into the affected skin until the foam disappears. Repeat Steps 4 and 5 to all the affected areas as prescribed by your healthcare provider. Step 6 : After applying LEXETTE, put the cap back on the can. Step 7: Wash your hands after applying LEXETTE unless you are using the medicine to treat your hands. Distributed by: Mayne Pharma Raleigh, NC 27609 U.S. Patent 10,857,159 and 11,020,407 Revised: 03/2023 Figure Figure Figure Figure Figure Figure
| This Instructions for Use has been approved by the U.S. Food and Drug Administration. | |
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION LEXETTE ® (lex-et) (halobetasol propionate) Topical Foam, 0.05% This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2023 Important: LEXETTE is for use on the skin only. Do not apply LEXETTE near or in your eyes, mouth, or vagina. What is LEXETTE? LEXETTE is a prescription corticosteroid medicine used on the skin to treat plaque psoriasis in people 12 years of age and older. It is not known if LEXETTE is safe and effective in children under 12 years of age. Before using LEXETTE, tell your healthcare provider about all of your medical conditions, including if you: have had irritation or other skin reaction to a steroid medicine in the past. have a skin infection. You may need medicine to treat the skin infection before using LEXETTE. 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 LEXETTE will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if LEXETTE passes into your breast milk. If you use LEXETTE and breastfeed, do not apply LEXETTE to your nipple or areola to avoid getting LEXETTE into your baby's mouth. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection, or use other products on your skin that contain corticosteroid. How should I use LEXETTE? See the " Instructions for Use " for detailed information about the right way to apply LEXETTE. Use LEXETTE exactly as your healthcare provider tells you to use it. Apply a thin layer of LEXETTE to the affected skin areas 2 times each day. You should not use more than 50 grams of LEXETTE in 1 week. Avoid using LEXETTE on your face, underarms (armpits), or groin areas. Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with LEXETTE. Do not use LEXETTE longer than 2 continuous weeks unless advised to do so by your prescriber. Wash your hands after using LEXETTE unless you are using the medicine to treat your hands. What should I avoid while using LEXETTE? LEXETTE is flammable . Avoid heat, flame, or smoking during and right after applying LEXETTE to your skin. What are the possible side effects of LEXETTE? LEXETTE may cause serious side effects, including: LEXETTE can pass through your skin . Too much LEXETTE passing through your skin can cause adrenal glands to stop working. Cushing's syndrome , a condition that happens when your body is exposed to too much of the hormone cortisol. High blood sugar (hyperglycemia). Vision problems . LEXETTE may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with LEXETTE. Skin reactions at the treated skin site . Tell your healthcare provider if you get any skin reactions or skin infections. Effects on growth and weight in children . Your healthcare provider may do certain blood tests to check for side effects. The most common side effect of LEXETTE is mild to moderate pain at the treated site. These are not all of the possible side effects of LEXETTE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store LEXETTE? Store LEXETTE at room temperature between 68°F to 77°F (20°C to 25°C). Do not puncture or burn LEXETTE can. Do not store LEXETTE next to heat or store at temperatures above120°F (49°C). Do not freeze LEXETTE. Keep LEXETTE and all medicines out of the reach of children. General information about the safe and effective use of LEXETTE. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LEXETTE for a condition for which it was not prescribed. Do not give LEXETTE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LEXETTE that is written for health professionals. What are the ingredients in LEXETTE? Active ingredient: halobetasol propionate Inactive ingredients: alcohol (specially denatured alcohol [SDA]), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water. LEXETTE is dispensed from an aluminum can pressurized with a hydrocarbon propellant containing isobutane and propane. Distributed by: Mayne Pharma Raleigh, NC 27609 U.S. Patent 10,857,159 and 11,020,407 For more information call: 1-844-825-8500
| PATIENT INFORMATION LEXETTE® (lex-et) (halobetasol propionate) Topical Foam, 0.05% | |
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| This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 03/2023 |
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Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES LEXETTE was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled studies (Study 1 [NCT02368210] and Study 2 [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 a static, five-level Investigator's Global Assessment (IGA) scale, on which a subject scored either moderate or severe. Overall, approximately 60% of subjects were male and approximately 90% were Caucasian. Subjects applied LEXETTE 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 a two-grade improvement from baseline at Week 2 (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 2 presents these results. Table 2: Efficacy Results at Week 2 in Subjects with Plaque Psoriasis Study 1 Study 2 LEXETTE N=75 Vehicle Foam N=76 LEXETTE N=205 Vehicle Foam N=204 Overall Treatment Success Subjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two-grade improvement from baseline based on the IGA. 19 (25%) 3 (4%) 63 (31%) 15 (7%) Plaque Elevation Subjects who were cleared or almost cleared of the designated clinical sign with at least a two-grade improvement from baseline. Individual signs were rated by severity using a five-point scale ranging from 0 (clear) to 4 (severe). Subjects with baseline value of 0 or 1 were excluded. 20/75 (27%) 3/76 (4%) 71/202 (35%) 20/203 (10%) Scaling 21/75 (28%) 4/76 (5%) 68/201 (34%) 20/204 (10%) Erythema 16/75 (21%) 2/76 (3%) 59/205 (29%) 17/204 (8%)
| Study 1 | Study 2 | |||
|---|---|---|---|---|
| LEXETTE N=75 | Vehicle Foam N=76 | LEXETTE N=205 | Vehicle Foam N=204 | |
| Overall Treatment Success | 19 (25%) | 3 (4%) | 63 (31%) | 15 (7%) |
| Plaque Elevation | 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%) |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies with LEXETTE included 131 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and effectiveness of LEXETTE in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. The safety and effectiveness of LEXETTE for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. Subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with LEXETTE. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 23 subjects. After 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 µg/dL) that recovered upon retesting after at least 4 weeks of stopping the treatment [see Clinical Pharmacology (12.2) ]. Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions (5.1) ]. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see Warnings and Precautions (5.1) ].
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary There are no available data on LEXETTE use in pregnant women to inform a 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 a 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 LEXETTE [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 Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. Halobetasol propionate was embryotoxic in rabbits, but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on LEXETTE use in pregnant women to inform a 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 a 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 LEXETTE [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 Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants. Animal Data Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. Halobetasol propionate was embryotoxic in rabbits, but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits. 8.2 Lactation Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LEXETTE and any potential adverse effects on the breastfed infant from LEXETTE or from the underlying maternal condition. Clinical Considerations Advise breastfeeding women not to apply LEXETTE directly to the nipple and/or areola to avoid direct infant exposure. 8.4 Pediatric Use The safety and effectiveness of LEXETTE in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. The safety and effectiveness of LEXETTE for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. Subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with LEXETTE. Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 23 subjects. After 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 µg/dL) that recovered upon retesting after at least 4 weeks of stopping the treatment [see Clinical Pharmacology (12.2) ]. Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions (5.1) ]. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see Warnings and Precautions (5.1) ]. 8.5 Geriatric Use Clinical studies with LEXETTE included 131 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied LEXETTE, 0.05% is a white to off-white foam. It is supplied in aluminum cans of: 50 grams (NDC 51862-604-50) 100 grams (2 cans of 50 grams) (NDC 51862-604-02) 16.2 Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF). Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze. 16.3 Handling LEXETTE is flammable; avoid heat, flame, or smoking when using this product.
Storage and handling
Information about safe storage and handling of the drug product.16.2 Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF). Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API