Vanos

1 INDICATIONS AND USAGE VANOS Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: • Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) • Avoid use on the face, groin, or axillae. ( 1.2 ) • Avoid use in perioral dermatitis or rosacea. ( 1.2 ) 1.1 Indications VANOS ® (fluocinonide) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4) ] . 1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of VANOS Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week. VANOS Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

2 DOSAGE AND ADMINISTRATION For topical use only. VANOS Cream is not for ophthalmic, oral, or intravaginal use. For psoriasis, apply a thin layer of VANOS Cream once or twice daily to the affected skin areas as directed by a physician. Twice-daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment. For atopic dermatitis, apply a thin layer of VANOS Cream once daily to the affected skin areas as directed by a physician. Once-daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14) ] . For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of VANOS Cream once or twice daily to the affected areas as directed by a physician. For topical use only. VANOS Cream is not for ophthalmic, oral, or intravaginal use. ( 2 ) Psoriasis: apply a thin layer once or twice daily to the affected skin areas. ( 2 ) Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. ( 2 ) Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. ( 2 )

4 CONTRAINDICATIONS None. None ( 4 )

5 WARNINGS AND PRECAUTIONS • VANOS Cream has been shown to suppress the HPA axis. Systemic absorption of VANOS Cream may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes. ( 5.1 ) • Systemic absorption may require evaluation for HPA-axis suppression. ( 5.1 ) • Modify use should HPA-axis suppression develop. ( 5.1 ) • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. ( 5.3 ) • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids. ( 5.3 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) 5.1 Effect on Endocrine System Systemic absorption of topical corticosteroids, including VANOS Cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of VANOS Cream for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1) ] . HPA-axis suppression has been observed with VANOS Cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis, and 4 out of 123 pediatric patients with atopic dermatitis [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2) ] . Because of the potential for systemic absorption, use of topical corticosteroids, including VANOS Cream, 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 more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. 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. 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 absorption of topical corticosteroids. Studies conducted in pediatric patients demonstrated reversible HPA-axis suppression after use of VANOS Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of VANOS Cream due to their larger skin surface-to-body-mass ratios [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, telangiectasis, 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 Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of VANOS Cream should be discontinued until the infection has been adequately controlled. 5.4 Allergic Contact Dermatitis If irritation develops, VANOS Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with VANOS Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Adverse Reaction VANOS Cream, once daily (n=216) VANOS Cream, twice daily (n=227) Vehicle Cream, once or twice daily (n=211) Headache 8 (3.7%) 9 (4.0%) 6 (2.8%) Application Site Burning 5 (2.3%) 4 (1.8%) 14 (6.6%) Nasopharyngitis 2 (0.9%) 3 (1.3%) 3 (1.4%) Nasal Congestion 3 (1.4%) 1 (0.4%) 0 Safety in patients 12 to 17 years of age was similar to that observed in adults. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VANOS Cream: • Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain, and condition aggravated. • Immune System Disorders: hypersensitivity. • Nervous System Disorders: headache and dizziness. • Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation, and skin tightness. 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.

8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, VANOS Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.