Vanos Drug Information
Generic name: FLUOCINONIDE
Corticosteroid [EPC]
Uses of Vanos
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.
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.
Dosage & Administration of Vanos
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 topical use only. Atopic Dermatitis: apply a thin layer once daily to the affected skin areas.
Side Effects of Vanos
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 0 Safety in patients 12 to 17 years of age was similar to that observed in adults.
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.
| 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 |
Warnings & Cautions for Vanos
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.
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.
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.
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.
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.
Pregnancy Safety for Vanos
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.
Pediatric Use of Vanos
Pediatric Use Safety and efficacy of VANOS Cream in pediatric patients younger than 12 years of age have not been established; therefore, use in pediatric patients younger than 12 years of age is not recommended. HPA-axis suppression was studied in four sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area (BSA), treated once daily or twice daily with VANOS Cream. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis.
Signs of skin atrophy were present at baseline and severity was not determined, making it difficult to assess local skin safety. Therefore, the safety of VANOS Cream in patients younger than 12 years of age has not been demonstrated. HPA-axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA-axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH 1-24 ) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Overdosage Information for Vanos
Topically applied VANOS Cream can be absorbed in sufficient amounts to produce systemic effects.
Clinical Studies of Vanos
Two adequate and well-controlled efficacy and safety studies of VANOS Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with VANOS Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment.
The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2. Table 2: Plaque-type Psoriasis in Adults No efficacy studies have been conducted to compare VANOS (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including fluocinonide cream 0.05%.
| VANOS Cream, once daily (n=107) | Vehicle, once daily (n=54) | VANOS Cream, twice daily (n=107) | Vehicle, twice daily (n=55) | |
|---|---|---|---|---|
| Subjects cleared | 0 (0) | 0 (0) | 6 (6%) | 0 (0) |
| Subjects achieving treatment success Cleared or almost cleared | 19 (18%) | 4 (7%) | 33 (31%) | 3 (5%) |
| VANOS Cream, once daily (n=109) | Vehicle, once daily (n=50) | VANOS Cream, twice daily (n=102) | Vehicle, twice daily (n=52) | |
|---|---|---|---|---|
| Subjects cleared | 11 (10%) | 0 (0) | 17 (17%) | 0 (0) |
| Subjects achieving treatment success Cleared or almost cleared | 64 (59%) | 6 (12%) | 58 (57%) | 10 (19%) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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