Actinic keratosis (AK) is a chronic, recurrent disease1,2

Patients with AK
typically require
regular follow-up and
repeated treatments1,2
15%-53% of AK
lesions recur within
1 year1
Many patients
develop additional
lesions within a year2

Rates of complete clearance 8 weeks after follow-up treatment in patients who had AKs present in the field at the efficacy evaluation after initial treatment3

Patients randomized to second treatment cycle following initial 8-week evaluation, and assessed 8 weeks
after beginning second cycle3

In an open-label study, all patients with AK on
the face or scalp (N=450) were initially treated
with Picato® for 3 consecutive days and assessed
8 weeks thereafter3
Patients who were not clear at week 8 were
randomized to receive either Picato® or vehicle3

Demonstrated safety profile

Mean composite local skin reaction (LSR) scores at Day 4 after a second treatment course were significantly reduced vs first treatment cycle:

mean difference was –1.22 (95% CI –1.90, –0.53; P<0.01). The most common LSRs were erythema and flaking/scaling.3

Pain at the site of application was the most common treatment-related AE during the first and second treatment cycles of Picato®.

Other frequently reported treatment-related AEs during the first treatment cycle were application-site pruritus (4.4%), headache (4.0%), eyelid edema (3.8%), and periorbital edema (3.3%), and during follow-up Picato® treatment, application-site pruritus (5.2%).3

A study further demonstrated the efficacy and safety of a follow-up course of Picato® in field* AK

Picato® was proven effective in patients who had AK lesions present in the field after initial treatment, or who later had them emerge in a previously cleared field‡3

Rates of complete clearance 8 weeks after follow-up treatment in patients who had new AKs in the previously cleared field3

Patients who were cleared at the initial 8-week assessment but developed new lesions when assessed at
weeks 26 or 44 were randomized to receive a second treatment cycle of Picato® or vehicle, and assessed
8 weeks after beginning the second cycle.3

In an open-label study, all patients with AK on
the face or scalp (N=450) were initially
treated with Picato® for 3 consecutive days
and assessed 8 weeks thereafter3
Patients were also randomized to a second
treatment cycle with Picato® or vehicle if
they had new AKs in the previously cleared
field at weeks 26 or 443

At 12 months, an estimated 50% of patients receiving either 1 or 2 cycles of Picato® were clear of AKs3

*Picato® is used to treat the field of AK, up to 25 cm2 per tube per treatment application.4

n=141.3

n=62.3

Important Safety Information

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%).

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.

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