LEXETTE
Generic: HALOBETASOL PROPIONATE
Basic Information
Manufacturer
Mayne Pharma
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
8aa1f819-c81f-4af1-aaa7-353df3203ff6
Indications & Usage
1 INDICATIONS AND USAGE LEXETTE ® is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
LEXETTE is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older.
( 1 )
LEXETTE is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions ( 5.1 )] • Allergic Contact Dermatitis [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions (≥1%) are application site pain and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 LEXETTE 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 Foam N=351 Vehicle Foam N=353 Adverse Reaction % % Application site burning/stinging 12% 15% Application site pain 1% <1% Headache 1% <1% Skin atrophy (n=1) and telangiectasia (n=2) were reported with LEXETTE, but not with vehicle foam.
6.2 Postmarketing Experience Because the 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.
The following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 LEXETTE 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 Foam N=351 Vehicle Foam N=353 Adverse Reaction % % Application site burning/stinging 12% 15% Application site pain 1% <1% Headache 1% <1% Skin atrophy (n=1) and telangiectasia (n=2) were reported with LEXETTE, but not with vehicle foam.
6.2 Postmarketing Experience Because the 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.
The following local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as halobetasol propionate.