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Indications and Usage
Picato® (ingenol mebutate) gel, 0.015%, 0.05% is indicated for the topical treatment of actinic keratosis.
Important Safety Information
Picato® is contraindicated in patients with known hypersensitivity to ingenol mebutate or any component of the formulation. Anaphylaxis, as well as allergic reactions leading to hospitalization have been reported in postmarketing use with Picato®. If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato® immediately and institute appropriate medical therapy.
For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid treatment in, near, or around the periocular area, mouth and lips. Inform patients that hypersensitivity reactions and/or ophthalmic adverse reactions can occur with Picato®. Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. To avoid transfer of the drug into the eyes and to the periocular area during and after application, patients should wash hands well after applying Picato® gel. If accidental exposure occurs, flush eyes with water and seek medical care.
In post-approval use of Picato®, the following adverse reactions have been identified: hypersensitivity (including anaphylaxis), allergic contact dermatitis, application site pigmentation changes, application site scarring and herpes zoster. 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.
Severe skin reactions in the treated areas on the face/scalp and trunk/extremities, including erythema, flaking/scaling, 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. The most common adverse reactions observed in clinical trials on the face and scalp (≥2%) are local skin reactions (94%), application site pain (15%), application site pruritus (8%), application site infection (3%), periorbital edema (3%), and headache (2%). The most common adverse reactions observed in clinical trials on the trunk and extremities (≥2%) are local skin reactions (92%), application site pruritus (8%), application site irritation (4%), nasopharyngitis (2%), and application site pain (2%).
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 under 18 years of age has not been established.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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