Male patient with Actinuc keratosis before and after treatment with Picato Male patient with Actinuc keratosis before and after treatment with Picato

For actinic keratosis, just 2- or 3-day dosing
with Picato® (ingenol mebutate) gel

3-day dosing of 0.015% gel for AK on the face or scalp and 2-day dosing of 0.05% gel for AK on the trunk or extremities.1

Efficacy was assessed at Day 57.1 Individual results may vary.

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® is here to help your eligible commercially insured* patients save with the LEO Pharma® CONNECT Co-Pay Savings Card

LEO® Co-Pay Savings Card LEO® Co-Pay Savings Card LEO® Co-Pay Savings Card

Picato® is here to help your eligible commercially insured* patients save with the LEO Pharma® CONNECT Co-Pay Savings Card

*Certain restrictions apply. This card may reduce out-of-pocket expenses. Must be 18 years of age or older to be eligible. Patients are not eligible if they are enrolled or they participate in any state or federally funded health care program (eg, Medicare, Medicaid, etc). For eligibility requirements and restrictions, visit Picato.com or call 1-855-820-9627.

*Certain restrictions apply. For patients with commercial health insurance, this card may reduce out-of-pocket expenses. Must be 18 years of age or older to be eligible. For eligibility requirements and program restrictions, visit Picato.com or call 1-855-820-9627.

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.

This site is intended for US residents only. The products discussed on this site may have different product labeling in different countries.

Click here for Full Prescribing Information.

Reference: 1. Picato® [prescribing information]. Madison, NJ: LEO Pharma Inc.
References: 1. Picato® [prescribing information]. Madison, NJ: LEO Pharma Inc. 2. Data on file. Clinical study report PEP005-025. Parsippany, NJ: LEO Pharma Inc.; 2010. 3. Data on file. Clinical study report PEP005-016. Parsippany, NJ: LEO Pharma Inc.; 2010. 4. Data on file. Clinical study report PEP005-028. Parsippany, NJ: LEO Pharma Inc.; 2010. 5. Data on file. Clinical study report PEP005-014. Parsippany, NJ: LEO Pharma Inc.; 2010. 6. ‭Data on ‭file. PEP005-016 and 025 clinical images. Ballerup, Denmark: Leo Pharma A/S; 2010. 7. Carac® (fluorouracil) Cream, 0.5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals; 2012. 8. Efudex® (fluorouracil) topical solutions and cream [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2012. 9. Zyclara® (imiquimod) Cream, 3.75% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 10. Aldara® (imiquimod) Cream, 5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 11. Solaraze® (diclofenac sodium) Gel, 3% [prescribing information]. Melville, NY: PharmaDerm; 2012. 12. Picato® [prescribing information]. Instructions for Use. Parsippany, NJ: LEO Pharma Inc.; 2015. 13. Picato® [patient prescribing information]. Madison, NJ: LEO Pharma Inc.; 2016.‬‬
Reference: 1. DRG Fingertip Formulary Analytics. Madison, NJ; LEO Pharma Inc. Accessed January 26, 2017.
References: 1. Picato® [prescribing information]. Madison, NJ: LEO Pharma Inc. 2. ‭Data on file. Clinical study report PEP005-028. Parsippany, NJ: LEO Pharma Inc.; 2010. ‭ 3. Data on file. Clinical study report PEP005-014. Parsippany, NJ: LEO Pharma Inc.; 2010. 4. Data on file. Clinical study report PEP005-025. Parsippany, NJ: LEO Pharma Inc.; 2010. 5. Data on file. Clinical study report PEP005-016. Parsippany, NJ: LEO Pharma Inc.; 2010. 6. Data on file. PEP005-028 clinical images. Ballerup, Denmark: Leo Pharma A/S; 2010. 7. Carac® (fluorouracil) Cream, 0.5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals; 2012. 8. Efudex® (fluorouracil) topical solutions and cream [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2012. 9. Zyclara® (imiquimod) Cream, 3.75%[prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 10. Aldara® (imiquimod) Cream, 5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 11. Solaraze® (diclofenac sodium) Gel, 3% [prescribing information]. Melville, NY: PharmaDerm; 2012. 12. Picato® [prescribing information]. Instructions for Use. Parsippany, NJ: LEO Pharma Inc.; 2015. 13. Picato® [patient prescribing information]. Madison, NJ: LEO Pharma Inc.; 2016.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
References: 1. Werner RN, Sammain A, Erdmann R, et al. The natural history of actinic keratosis: a systemic review. Br J Dermatol. 2013;169(3):502-518. 2. Frost C, Williams G, Green A. High incidence and regression rates of solar keratosis in a Queensland community. J Invest Dermatol. 2000;115(2):273-277. 3. Garbe C, Basset-Seguin N, Poulin Y, et al. Efficacy and safety of follow-up field treatment of actinic keratosis with ingenol mebutate 0.015% gel: a randomised controlled 12-month study. Br J Dermatol. 2016;174(3):505-513. 4. Picato® [prescribing information]. Madison, NJ: LEO Pharma Inc.

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