Desoximetasone

5 WARNINGS AND PRECAUTIONS Desoximetasone Topical Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. ( 5.1 ) Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. ( 5.1 ) Modify use if HPA axis suppression develops. ( 5.1) High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. ( 5.1 ) Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) Desoximetasone Topical Spray is flammable; keep away from heat or flame. ( 5.5 ) 5.1 Effect on Endocrine System Desoximetasone Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10 to 15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Desoximetasone Topical Spray twice a day for 28 days. [ see Clinical Pharmacology (12.2) ] Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, 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, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [ see Use in Specific Populations (8.4) ] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Desoximetasone Topical Spray should be discontinued until the infection has been adequately treated. 5.5 Flammable Contents Desoximetasone Topical Spray is flammable; keep away from heat or flame.

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 Taro Pharmaceuticals, U.S.A., Inc., at 1-866-923-4914 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 or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Desoximetasone Topical Spray. Adverse reactions that occurred in ≥ 1% of subjects treated with Desoximetasone Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%). Another less common adverse reaction (<1% but >0.1%) was folliculitis. Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% 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%)

<table width="75%"><caption>Table 1. Number (%) of Subjects with Adverse Reactions Occurring in &#x2265; 1%</caption><col width="40%" align="left" valign="middle"/><col width="30%" align="center" valign="middle"/><col width="30%" align="center" valign="middle"/><thead><tr><th styleCode="Lrule Rrule"/><th styleCode="Rrule" valign="top">Desoximetasone Topical Spray, 0.25% <content styleCode="italics">b.i.d.</content> (N = 149) </th><th styleCode="Rrule" valign="top">Vehicle spray <content styleCode="italics">b.i.d.</content> (N = 135) </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Number of Subjects with Adverse Reactions</td><td styleCode="Rrule">13 (8.7%)</td><td styleCode="Rrule">18 (13.3%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Application site dryness</td><td styleCode="Rrule">4 (2.7%)</td><td styleCode="Rrule">7 (5.2%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Application site irritation</td><td styleCode="Rrule">4 (2.7%)</td><td styleCode="Rrule">5 (3.7%)</td></tr><tr><td styleCode="Lrule Rrule">Application site pruritus</td><td styleCode="Rrule">3 (2.0%)</td><td styleCode="Rrule">5 (3.7%)</td></tr></tbody></table>