desoximetasone

1 INDICATIONS AND USAGE Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older ( 1 ). Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

2 DOSAGE AND ADMINISTRATION Apply Desoximetasone Topical Spray as a thin film to the affected skin areas twice daily. Rub in gently. The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician. Desoximetasone Topical Spray should be discontinued when control is achieved. Treatment beyond 4 weeks is not recommended. Do not use if atrophy is present at the treatment site. Avoid use on the face, axilla or groin. Desoximetasone Topical Spray is for external use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected skin areas twice daily. Rub in gently. ( 2 ) Desoximetasone Topical Spray should be discontinued when control is achieved. ( 2 ) Treatment beyond 4 weeks is not recommended. ( 2 ) Do not use if atrophy is present at the treatment site. ( 2 ) Do not use with occlusive dressings, unless directed by the physician ( 2 ) Avoid use on the face, axilla or groin. ( 2 ) Desoximetasone Topical Spray is not for oral, ophthalmic, or intravaginal use. ( 2 )

3 DOSAGE FORMS AND STRENGTHS Spray, 0.25% w/w ( 3 ) Topical Spray, 0.25%. Each gram of desoximetasone topical spray contains 2.5 mg of desoximetasone USP in a clear, colorless liquid.

4 CONTRAINDICATIONS None None ( 4 )

6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) are application site dryness, application site irritation and application site pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 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, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied desoximetasone topical spray, 0.25% or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied desoximetasone topical spray, 0.25%. Adverse reactions that occurred in ≥ 1% of subjects treated with desoximetasone topical spray, 0.25% are presented in Table 1. Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Another less common adverse reaction (0.1%) was folliculitis. Desoximetasone Topical Spray, 0.25% b.i.d (N = 149) Vehicle spray b.i.d. (N = 135) Number of Subjects with Adverse Reactions 13 (8.7%) 18 (13.3%) Application site dryness 4 (2.7%) 7 (5.2%) Application site irritation 4 (2.7%) 5 (3.7%) Application site pruritus 3 (2.0%) 5 (3.7%) Another less common adverse reaction (0.1%) was folliculitis. 6.2 Postmarketing Experience Because adverse 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. Postmarketing reports for local adverse reactions to topical corticosteroids included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria. Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported during use of topical corticosteroids.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on desoximetasone use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids, including Desoximetasone topical spray, 0.25%, may be associated with an increased risk of low birthweight infants (see Data) . Advise pregnant woman that Desoximetasone topical spray, 0.25% may increase the potential risk of low birth weight infants and to use Desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible. Desoximetasone has been shown to cause malformations and be embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Desoximetasone topical spray, 0.25% based on a body surface area comparison. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of high to super-high potency topical corticosteroids exceeded 300g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. 8.2 Lactation Risk Summary There is no information on the presence of topically administered desoximetasone in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for desoximetasone topical spray, 0.25% and any potential adverse effects on the breastfed infant from desoximetasone topical spray, 0.25% or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use desoximetasone topical spray, 0.25% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply desoximetasone topical spray, 0.25% directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . 8.4 Pediatric Use The safety and effectiveness of desoximetasone topical spray, 0.25% have not been established in pediatric patients for the treatment of plaque psoriasis. Desoximetasone topical spray, 0.25% is not recommended for use in patients less than 18 years of age due to the high incidence of HPA axis suppression observed [see Warnings and Precautions ( 5.1 )] . Hypothalamic-Pituitary Adrenal (HPA) Axis Suppression The HPA axis suppression potential of desoximetasone topical spray, 0.25% was assessed in an open-label, sequential cohort, safety trial in 129 subjects 2 years to less than 18 years of age with moderate to severe plaque psoriasis defined as a Physician Global Assessment (PGA) score of ≥3 with involvement of at least 10% of their body surface area (excluding the face and scalp). In total, 100 pediatric subjects were evaluated for HPA axis function via cosyntropin stimulation testing at baseline and following 4 weeks of twice daily application of desoximetasone topical spray, 0.25%. Overall, 36% of pediatric subjects 2 years to less than 18 years of age demonstrated HPA axis suppres …

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 psoriasis is unknown.

11 DESCRIPTION Desoximetasone topical spray, 0.25% for dermatologic use contains desoximetasone as the active ingredient. Desoximetasone is a corticosteroid with the chemical name of pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11ß,16α)-. Desoximetasone has the molecular formula of C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is: Each gram of desoximetasone topical spray, 0.25% contains 2.5 mg of Desoximetasone USP in a clear, colorless liquid with the following inactive ingredients: butylated hydroxytoluene, citric acid anhydrous, diisopropyl adipate, isopropyl alcohol (23.4%), L-menthol, medium-chain triglycerides, mineral oil and sorbitan monooleate. Desoximetasone topical spray, 0.25% is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients. structure

10 OVERDOSAGE Desoximetasone topical spray, 0.25% can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions ( 5.1 )]

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied/Storage Desoximetasone topical spray, 0.25% is a clear, colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes: 30 mL (NDC 68180-944-11) 50 mL (NDC 68180-944-22) 100 mL (NDC 68180-944-33) Store at controlled room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Spray is flammable; avoid heat, flame or smoking when using this product. Each unit is co-packaged with a manual spray pump for installation by the pharmacist. 16.2 Instructions for the Pharmacist Remove the spray pump from the wrapper Remove and discard the cap from the bottle Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened Dispense the bottle with the spray pump inserted Label the bottle with "discard the product 30 days after dispensing"

16.1 How Supplied/Storage Desoximetasone topical spray, 0.25% is a clear, colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes: 30 mL (NDC 68180-944-11) 50 mL (NDC 68180-944-22) 100 mL (NDC 68180-944-33) Store at controlled room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Spray is flammable; avoid heat, flame or smoking when using this product. Each unit is co-packaged with a manual spray pump for installation by the pharmacist.