Journal of Clinical and Aesthetic Dermatology

FEB 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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Page 16 of 62

Rx Only BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. DOSAGE AND ADMINISTRATION a reas twice daily and rub in gently. Use SERNIVO Spray for up to 4 weeks of tre atment. Tre atment beyond 4 weeks is not recommended. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. SERNIVO Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use. CONTRAINDICATIONS Non e. WARNINGS AND PRECAUTIONS Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for occur during or after withdrawal of treatment. Fac tors th at predispose to HPA axis suppression include the use of high-potency cortico ste roids, la rge tre atment surfa ce a reas, prolonged use, use of o cclusive dre ssings, altered skin barrier, liver failure, and young age. Evalu ation for HPA axis suppre ssion may be done by using the adreno corticotropic hormone (ACTH) stimulation te st. In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after tre atment with SERNI VO Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation te st results after tre atment with SERNI VO Spray twice daily for 29 days [see Clinical Pharma cology]. If HPA axis suppre ssion is documen ted, gradually withdraw the drug, redu ce the frequen cy of applic ation, or substitu te with a le ss po tent cortico ste roid. If signs and symptoms of steroid withdrawal occur, supplemental systemic cortico ste roids may be required. may also manifest as Cushing's syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Minimize the unwanted risks from endocrine increased systemic bioavailability and by using the product as recommended [see Dosage and Administration]. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of SERNIVO Spray is not recommended in pediatric patients [see Use in Specific Population s]. Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials a re conduc ted 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 two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle sp ray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray. Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d. (N= 352) Vehicle Spray b.i .d (N=180) Application site pruritus 6.0% 9.4% Application site burning and/or stinging 4.5% 10.0% Applic ation site pain 2.3% 3.9% Applic ation site atrophy 1.1% 1.7% Le ss common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects tre ated with SERNI VO spray we re applic ation site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects tre ated with vehicle. Postmarketing Experien ce Because adverse reactions a re reported voluntarily from a population of un certain size, it is not always possible to reliably e stimate their frequen cy or e stablish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. SERNIVO Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular rou te at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid is not known whether topical administration of absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when SERNIVO Spray is administered to a nursing woman. Pediatric Use in patients younger than 18 years of age have not been studied; the re fo re use in pediatric patients is not recommended. Because of a higher ratio of skin surfa ce a rea to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis treated with topical drugs. [see Warnings and Precaution s] syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including skin atrophy h ave also been reported with use of topical cortico ste roids in pediatric patients. Geri atric Use Clinical studies of SERNI VO Spray did not we re 65 years of age or older to de termine younger subjects. Manu factu red by: DPT Labo ratories, Ltd., San Antonio, TX 78215 Distribu ted by: Promius Pharma, L LC., Princeton, NJ 08540 Sernivo is a trademark of Promius Pharma, LLC. I ssued: 02 /2 016

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