Halobetasol Propionate

HALOBETASOL PROPIONATE- halobetasol propionate aerosol, foam
Mayne Pharma

1 INDICATIONS AND USAGE

Halobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

Shake can prior to use. Apply Halobetasol Propionate Topical Foam as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product.

Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of the diagnosis may be necessary.

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary­ adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Do not use with occlusive dressings unless directed by a physician.

Avoid use on the face, groin, or axillae.

Avoid contact with eyes. Wash hands after each application, unless it is for treatment of the hands.

Halobetasol Propionate Topical Foam is for topical use only.

Halobetasol Propionate Topical Foam is not for ophthalmic, oral, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Halobetasol Propionate Topical Foam is a white to off-white topical foam. Each gram of Halobetasol Propionate Topical Foam, 0.05% contains 0.5 mg of halobetasol propionate.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects

Halobetasol Propionate Topical Foam is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid. The potential for hypothalamic-pituitary adrenal (HPA) suppression with Halobetasol Propionate Topical Foam was evaluated in a study of 25 adult subjects with moderate to severe plaque psoriasis involving ≥15% of their body surface area. Halobetasol Propionate Topical Foam produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in 6 out of 25 (24%) adult subjects with plaque psoriasis. Recovery of HPA axis function was generally prompt with the discontinuation of treatment [see Clinical Pharmacology (12.2)].

Because of the potential for systemic absorption, use of topical corticosteroids, including Halobetasol Propionate Topical Foam, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or 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.

Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.

Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios [see Use in Specific Populations (8.4)].

5.2 Local Adverse Reactions

Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Halobetasol Propionate Topical Foam. Some local adverse reactions may be irreversible.

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.

5.4 Concomitant Skin Infections

Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Halobetasol Propionate Topical Foam until the infection has been adequately treated.

5.5 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue Halobetasol Propionate Topical Foam if allergic contact dermatitis is established.

5.6 Flammability

Halobetasol Propionate Topical Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

6.1 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 practice.

In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with Halobetasol Propionate Topical Foam twice daily for up to two weeks (up to approximately 50 grams per week). Table 1 presents selected adverse reactions that occurred in at least 1% of subjects.

Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects through Week 2
HBP FoamN=351 Vehicle FoamN=353
Adverse Reaction % %
Skin atrophy (n=1) and telangiectasia (n=2) were reported with Halobetasol Propionate Topical Foam, but not with vehicle foam.
Application site burning/stinging 12% 15%
Application site pain 1% <1%
Headache 1% <1%

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on Halobetasol Propionate Topical Foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of Halobetasol Propionate Topical Foam [see Clinical Pharmacology (12.3)].

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. Halobetasol propionate was embryotoxic in rabbits, but not in rats. Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

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