Picato® for Body, Arms, and Legs

Clinically proven efficacy in field* actinic
keratosis (AK) treatment with Picato®

With just 2 days of once-daily dosing on the body, arms, or legs†1

Percentage of patients with 100% clearance of all AKs in the field, whether present or emergent during treatment, assessed at Day 571 (P<0.001)2,3

Percentage of patients with complete clearance of actinic keratosis with Picato on the body, arms, and legs Percentage of patients with complete clearance of actinic keratosis with Picato on the body, arms, and legs
In clinical trials, 98% of subjects completed treatment1
In clinical trials, 98% of subjects completed treatment1

Percentage of patients with ≥75% clearance of all AKs in the field, whether present or emergent during treatment, assessed at Day 571 (P<0.001)2,3

Patients with 75% or more clearance of AK using Picato on the body, arms, and legs Patients with 75% or more clearance of AK using Picato on the body, arms, and legs

Data from two clinical studies (N=458) in AK on the body, arms, and legs in patients with a mean age range of 65-67 years, of whom 62%-63% were male. Primary endpoint was complete clearance at Day 57, while secondary endpoint was partial clearance at Day 57.2,3

*Picato® is used to treat the field of AK, up to 25 cm2 per tube per treatment application.1

Efficacy was assessed at Day 57.1

Important Safety Information

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.

For additional Important Safety Information, click here.

Study Design 1

Study design for 2 pivotal trials: multicenter, randomized, parallel group, double-blind, vehicle-controlled studies of 458 adult patients with 4 to 8 clinically typical, visible, discrete AK lesions evaluating the efficacy and safety of Picato® compared with vehicle gel when administered once daily for 2 consecutive days to a contiguous 25 cm2 area of skin on nonhead locations. Hypertrophic and hyperkeratotic lesions were excluded from treatment and 94% of subjects had Fitzpatrick skin Type I, II, or III. The primary endpoint was complete clearance rate of AK lesions and was defined as the proportion of subjects with no (zero) visible AK lesions in the treatment area at Day 57.1

Picato® demonstrated complete clearance rates of 89% and 60% on the chest (vs 13% and 33% for vehicle), 26% and 46% on the arm (vs 5% for vehicle), 16% and 21% on the back of the hand (vs 0% for vehicle), and 13% and 75% on other nonhead locations (vs 10% and 17% for vehicle).1

Study Design 2

Study design for 2 pivotal trials: multicenter, randomized, parallel group, double-blind, vehicle-controlled studies of 458 adult patients with 4 to 8 clinically typical, visible, discrete AK lesions evaluating the efficacy and safety of Picato® compared with vehicle gel when administered once daily for 2 consecutive days to a contiguous 25 cm2 area of skin on nonhead locations. Hypertrophic and hyperkeratotic lesions were excluded from treatment and 94% of subjects had Fitzpatrick skin Type I, II, or III. Partial clearance was defined as the proportion of subjects with ≥75% reduction in the number of AK lesions at baseline in the selected treatment area.1

The recurrence rate of AK lesions at 12 months for patients who achieved complete clearance was 50%.1

In clinical trials, patients were treated at various months of the year‡2-5 all seasons calendar
all seasons calendar
In clinical trials, patients were treated at various months of the year‡2-5

Due to the nature of AK, excessive or prolonged exposure to UV light should always be avoided.

Local skin reactions (LSRs) are typically predictable in their emergence and resolution1

Skin reactions on the body, arms, and legs typically occur on the first day of application, peak within 1 week, and resolve within 4 weeks1

LSRs are mostly mild to moderate in severity, although some serious or severe skin reactions have been reported. Though LSRs are predictable in their emergence and resolution, the intensity and type of reaction will differ by patient.1

Body, arms, and legs6
  • Patient 1 | MILD
  • Patient 2 | MODERATE
  • Patient 3 | SEVERE
Patient 1 | MILD
  • Patient 1 | MILD
  • Patient 2 | Moderate
  • Patient 3 | Severe
ARM
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
CHEST
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
ARM
Before Treatment
57 Days After Start
3 Days After Start
8 Days After Start
29 Days After Start
Before Treatment
3 Days After Start
8 Days After Start
29 Days After Start
57 Days After Start
ARM
Before
Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days
After Start
Local Skin reactions from Picato treatment on the face and scalp
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
CHEST
Before
Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
ARM
Before
Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days
After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
Before Treatment
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
3 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
8 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
29 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato
57 Days After Start
Local skin reactions on the body, arms, and legs over the course of treatment with Picato

Skin reactions for the body, arms, and legs included erythema (92%), flaking/scaling (90%), crusting (74%), swelling (64%), vesiculation/pustulation (44%), and erosion/ulceration (26%). Grade 4 reactions were erythema (15%), flaking/scaling (8%), crusting (4%), swelling (3%), vesiculation/pustulation (1%), and erosion/ulceration (1%).1

These images represent a range of skin reactions, from mild to severe, experienced by patients treated in 2 AK clinical trials on the body, arms, and legs. Individual results may vary.1

Adverse reactions were mostly mild
to moderate
  • Body trials: application site pruritus (8%) application site irritation (4%), nasopharyngitis (2%), application site pain (2%)1
  • Instances of severe skin reactions have been reported at rates of 1% to 15% for the body, arms, and legs1
Low systemic absorption
  • In 2 studies (N=16), systemic absorption was below the limit of quantification (0.1 ng/mL) when 4 tubes of Picato® (0.05%) were applied to 4 consecutive 25 cm2 treatment areas*1

*Picato® is used to treat the field of AK, up to 25 cm2 per tube per treatment application.1

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 additional Important Safety Information, click here.

Picato® has the fastest dosing of any AK topical treatment†1,7-11

comparison of dosing regimens for Picato and other topical treatments on the body, arms, and legs comparison of dosing regimens for Picato and other topical treatments on the body, arms, and legs

Indications, efficacy, and safety of the products listed above vary. This chart is not intended to
compare the safety or efficacy of products.

Efficacy was assessed at Day 57.1

Important Safety Information

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.

For additional Important Safety Information, click here.

Remind your patients how to
apply Picato®

Remind patients

to always store
Picato®
in a
refrigerator at
36°F
to 46°F
(2°C to 8°C)1
Once-daily
dosing in
5 steps12
1 | Open a new tube each time you
use Picato® gel. Remove
cap from tube just before use.
2 | Squeeze the gel from the tube onto your fingertip. Only use enough gel needed to cover the affected area (up to one contiguous skin area of approximately 25 cm2), as directed by your healthcare provider.
3 | Spread the gel evenly over only the skin area to be treated.
4 | Wash your hands right away after applying gel. If treating your hands, wash only the fingertip you used to apply the gel. Safely throw away the tube after single use.
5 | Dry treated area for 15 minutes.
IMPORTANT:
  • One tube will cover an area of about 2 x 2 inches12
  • Keep out of the reach of children13
  • Avoid touching the treatment area or doing activities that cause a lot of sweating for 6 hours after
    applying Picato® gel12
  • Do not use Picato® gel in, around, or near your eyes, mouth, lips, or vagina13
  • Do not apply right after taking a shower or less than 2 hours before bedtime12
  • Due to the nature of AK, excessive or prolonged exposure to UV light should always be avoided

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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