Drugs Xagena
The FDA ( U.S. Food and Drug Administration ) has approved Picato ( Ingenol mebutate ) gel ( 0.015%, 0.05% ) for the topical treatment of actinic keratosis.
Actinic keratosis is a precancerous condition caused by cumulative sun exposure that has the potential to progress to squamous cell carcinoma, the second most common type of skin cancer.
Picato 0.015% gel is used once daily on the face and scalp for three consecutive days, and Picato 0.05% gel is used once daily on the trunk and extremities for two consecutive days.
Picato gel is the first and only topical actinic keratosis therapy that can be used for as little as two or three days.
According to the American Academy of Dermatology ( AAD ), 1 in 5 Americans will develop skin cancer in the course of their lifetime.
Studies have shown that about 65% of squamous cell carcinomas begin as untreated actinic keratosis, and guidelines from the AAD estimate that 60% of predisposed persons older than 40 have at least one actinic keratosis.
Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical.
In four phase III clinical studies of more than 1,000 patients with actinic keratosis, a significantly higher proportion of those treated with Picato gel ( n=503 ) saw complete clearance of actinic keratosis in the field of treatment as compared to placebo ( n=502 ).
The most common adverse events were local skin reactions, including erythema, flaking/scaling, crusting and swelling.
Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure to Picato. Patients should wash hands well after applying Picato gel, and avoid transfer of the drug to the periocular area during and after application.
Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation / pustulation, and erosion / ulceration, can occur after application.
Administration of Picato gel is not recommended until the skin is healed from any previous drug or surgical treatment.
There are no adequate and well-controlled studies of Picato gel in pregnant women. Picato gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The safety and effectiveness of Picato gel for actinic keratosis in patients less than 18 years of age have not been established.
Actinic keratosis is a dry, scaly, rough-textured patch or lesion that forms on the outermost layer of the skin after cumulative exposure to ultraviolet ( UV ) light, such as sunlight. In some cases, the lesions may be easier to feel than see.
The name actinic keratosis literally means sun-induced rough spot and therefore the lesions, which can be gray, pink, red or the same color as the skin, are often called sun spots and/or age spots.
A job that requires spending hours of time outside, or everyday activities such as gardening, exercise or attending outdoor sporting events, can lead to sun damage if skin isn't adequately protected.
People at high risk are often fair-skinned men and women over the age of 40 who may have accumulated a significant amount of sun exposure over the course of many years. ( Xagena )
Source: Leo Pharma, 2012
XagenaMedicine_2012
