Sernivo Drug Information

Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Shake well before use. Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently. Use SERNIVO Spray for up to 4 weeks of treatment.

Treatment beyond 4 weeks is not recommended. Discontinue SERNIVO Spray when control is achieved. Do not use if atrophy is present at the treatment site.

Do not bandage, cover, or wrap the treated skin area unless directed by a physician. 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. Apply to the affected skin areas twice daily. Rub in gently.

Use SERNIVO Spray for up to 4 weeks and not beyond. Discontinue treatment when control is achieved. Do not use if atrophy is present at the treatment site.

Do not use with occlusive dressings unless directed by a physician. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. Not for oral, ophthalmic, or intravaginal use.

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 clinical practice. In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray 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% Application site pain 2.3% 3.9% Application site atrophy 1.1% 1.7% Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with SERNIVO Spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

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 have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported with the use of topical corticosteroids, including topical betamethasone products.

Pregnancy There are no available data on SERNIVO Spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that SERNIVO Spray may increase the risk of having a low birthweight infant and to use SERNIVO Spray on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of SERNIVO Spray. The estimated 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Pediatric Use Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied, therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. Rare systemic effects such as Cushing'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 have also been reported with use of topical corticosteroids in pediatric patients.