Verdeso

VERDESO- desonide aerosol, foam
Almirall, LLC

1 INDICATIONS AND USAGE

VERDESO® (desonide) Foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Patients should be instructed to use VERDESO Foam for the minimum amount of time necessary to achieve the desired results because of the potential for VERDESO Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.

2 DOSAGE AND ADMINISTRATION

VERDESO Foam is not for oral, ophthalmic, or intravaginal use.

A thin layer of VERDESO Foam should be applied to the affected area(s) twice daily. Shake the can before use. VERDESO Foam should be dispensed by inverting the can (upright actuation will cause loss of the propellant which may affect product delivery). Dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer.

The medication should not be dispensed directly on the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly onto the affected area. Take care to avoid contact with the eyes or other mucous membranes.

Therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. The safety and efficacy of VERDESO Foam has not been established beyond 4 weeks of use.

Unless directed by a physician, VERDESO Foam should not be used with occlusive dressings.

3 DOSAGE FORMS AND STRENGTHS

Foam, 0.05%. Each gram of VERDESO Foam contains 0.5 mg of desonide in a white to off-white petrolatum-based emulsion aerosol foam.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

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 post-treatment.

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. [see Use 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 Ophthalmic Adverse Reactions

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products [see Adverse Reactions (6.2)].

Avoid contact of VERDESO Foam with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.4 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.

5.5 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).

6 ADVERSE REACTIONS

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 (N = 387) Vehicle (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.

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