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warnings and cautions
5 WARNINGS AND PRECAUTIONS • VERDESO Foam has been shown to produce reversible HPA axis suppression. ( 5.1 , 8.4 , 14 ) • Systemic effects of topical corticosteroids may also include manifestations of Cushing's syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal syndrome, and growth retardation in children. ( 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 , 5.5 ) • Modify use should HPA axis suppression develop. ( 5.1 ) • Potent corticosteroids, use on large areas, prolonged use, or occlusive use may increase systemic absorption. ( 5.1 ) • Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 , 12.2 ) • Concomitant therapy with topical corticosteroids should be used with caution because a cumulative effect may occur. ( 5.1 ) • Discontinue use if irritation develops. ( 5.2 ) • Initiate appropriate therapy if concomitant skin infections develop. ( 5.3 ) • The propellant in VERDESO Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. ( 5.4 ) 5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression VERDESO Foam has been shown to reversibly suppress the HPA axis. Topical application of VERDESO Foam may result in systemic absorption and effects including HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal, and growth retardation in children. Use of VERDESO Foam for longer than 4 weeks may suppress the immune system [ see Nonclinical Toxicology (13.1) ] . Conditions that augment systemic absorption include the application of topical corticosteroids over large body surface areas, prolonged use, or the addition of occlusive dressings. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. An adrenocorticotropic hormone (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. The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects in one trial. In this trial, subjects with atopic dermatitis covering at least 25% of their body applied VERDESO Foam twice daily for 4 weeks. Three out of 75 subjects (4%) displayed adrenal suppression after 4 weeks of use based on the cosyntropin stimulation test. The laboratory suppression was transient; all subjects had returned to normal when tested 4 weeks posttreatment. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of VERDESO Foam due to their larger skin surface-to-body mass ratios. [seeUse in Specific Populations ( 8.4 )] . Concomitant therapy with topical corticosteroids should be used with caution because a cumulative effect may occur. 5.2 Skin Irritation VERDESO Foam may cause local skin adverse reactions [see Adverse Reactions ( 6 )] . If irritation develops, VERDESO Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.3 Concomitant Skin Infections If concomitant skin infections are present or develop, the use of an appropriate antifungal, antibacterial, or antiviral agent should be instituted. If a favorable response does not occur promptly, use of VERDESO Foam should be discontinued until the infection has been adequately controlled. 5.4 Flammable Contents The contents of VERDESO Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame, and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C). 5.5 Laboratory Tests The cosyntropin (ACTH 1-24 ) stimulation test may be helpful in evaluating patients for HPA axis suppression.
6 ADVERSE REACTIONS • The most common adverse reactions (>1%) are upper respiratory tract infection, cough, application site burning, headache, viral infection, and increased blood pressure. ( 6.1 ) • In postmarketing reports, the most common adverse reactions were application site irritation followed by application site erythema. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Stiefel Laboratories, Inc. at 1-888-784-3335 (STIEFEL) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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 clinical practice. In a controlled clinical trial of 581 subjects aged 3 months to 17 years, adverse reactions occurred at the application site in 6% of subjects treated with VERDESO Foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse reactions for VERDESO Foam and vehicle foam are noted in Table 1. Table 1—Adverse Reactions in the Clinical Trial Adverse Reaction VERDESO Foam Vehicle Foam (N = 387) (N = 194) Upper respiratory tract infection 37 (10%) 12 (6%) Cough 14 (4%) 3 (2%) Application site burning 11 (3%) 15 (8%) Viral infection 6 (2%) 0 (0%) Elevated blood pressure 6 (2%) 1 (1%) Headache 7 (2%) 1 (1%) Asthma 3 (1%) 0 (0%) Irritability 2 (1%) 0 (0%) Pharyngitis 2 (1%) 0 (0%) Application site atrophy 5 (1%) 0 (0%) Application site reactions (including atrophy, striae, telangiectasia and pigmentation changes) 3 (1%) 6 (3%) Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. 6.2 Postmarketing Experience Because these 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 adverse reactions have been identified during post-approval use of VERDESO Foam: application site irritation, application site erythema, application site reactions, skin reactions, and swelling face.