Male patient with Actinuc keratosis before and after treatment with Picato Male patient with Actinuc keratosis before and after treatment with Picato
Review data with expert Brian Berman, M.D., PhD.

*3-day dosing of 0.015% gel for actinic keratosis (AK) on the face or scalp and 2-day dosing of 0.05% gel for AK on the trunk or extremities. Efficacy was assessed at Day 57. Individual results may vary. Picato® is used to treat the field of AK, up to 25 cm2 per tube per treatment application. Avoid doing activities that cause a lot of sweating for 6 hours after treatment.1

Picato® Video Resource

Explore the Benefits of Topical Field Treatment for Actinic Keratosis

Listen to renowned dermatologist and lead investigator
Brian Berman, M.D., PhD., examine Picato® clinical data and provide his perspective on the importance of treating AK patients with topical field treatments.

Benefits of Topical Field Treatment for Actinic Keratosis
For optimal viewing experience, recommend watching video in full screen.

In the treatment of AK...

Picato® Demonstrates Powerful Efficacy. Sustained Clearance.

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

IMPORTANT SAFETY INFORMATION

Picato® gel 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 of Picato® gel.

For additional IMPORTANT SAFETY INFORMATION, click here.

LEO 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

LEO 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. Click here for full terms and conditions and eligibilty requirements or call 1-877-678-7494 between 8:30 am and 8:30 pm (Eastern), Monday through Friday.

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. Click here for full terms and conditions and eligibilty requirements or call 1-877-678-7494 between 8:30 am and 8:30 pm (Eastern), Monday through Friday.

INDICATIONS AND USAGE

Picato® (ingenol mebutate) gel is indicated for the topical treatment of actinic keratosis. For treatment on the face or scalp, Picato® gel 0.015% should be applied to the affected area once daily for 3 consecutive days. For treatment on the trunk or extremities, Picato® gel 0.05% should be applied to the affected area once daily for 2 consecutive days.


IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

Picato gel 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 of Picato gel.

For topical use only. Picato gel is not for oral, ophthalmic or intravaginal use. Avoid transfer of Picato gel to periocular area or application near and around the mouth and lips. For application of up to one contiguous skin area of approximately 25 cm2 (5 cm x 5 cm) using one unit dose tube. Patients should wash hands well immediately after application.


WARNINGS AND PRECAUTIONS

  • Ophthalmic Adverse Reactions: Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible.
  • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and allergic contact dermatitis, have been reported postmarketing. If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato gel immediately and institute appropriate medical therapy.
  • Local Skin Reactions: Severe skin reactions in the treated area, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration can occur after topical application of Picato gel. Administration of Picato gel is not recommended until the skin is healed from any previous drug or surgical treatment.

ADVERSE REACTIONS

  • The most common adverse reactions observed in clinical trials with use of Picato 0.015% 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 with use of Picato 0.05% 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%).
  • In post approval use of Picato gel, 0.015% and 0.05%, the following adverse reactions have been identified: hypersensitivity, allergic contact dermatitis, application site pigmentation changes, application site scarring, herpes zoster, chemical conjunctivitis, corneal burn, and Stevens-Johnson Syndrome. 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.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data on Picato gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Lactation: There are no data on the presence of ingenol mebutate in human or animal milk, the effects on the breastfed infant or the effects on milk production. Advise breastfeeding women to avoid accidental transfer of Picato gel to the nipple and areola area to prevent direct infant exposure.

Pediatric Use: The safety and effectiveness of Picato gel for actinic keratosis in patients less than 18 years of age have not been established.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email to usdrugsafety@leo-pharma.com.

Please 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. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012;366(11):1010-1019. 5. ‭Data on ‭file. PEP005-016 and 025 clinical images. Ballerup, Denmark: Leo Pharma A/S; 2010. 6. Carac® (fluorouracil) Cream, 0.5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals; 2012. 7. Efudex® (fluorouracil) topical solutions and cream [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2012. 8. Zyclara® (imiquimod) Cream, 3.75% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 9. Aldara® (imiquimod) Cream, 5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 10. Solaraze® (diclofenac sodium) Gel, 3% [prescribing information]. Melville, NY: PharmaDerm; 2012. 11. Picato® [prescribing information]. Instructions for Use. Madison, NJ: LEO Pharma Inc.
Reference: 1. DRG Fingertip Formulary Analytics. Madison, NJ; LEO Pharma Inc. Accessed August 22, 2018.
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. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012;366(11):1010-1019. 5. Data on file. PEP005-028 clinical images. Ballerup, Denmark: Leo Pharma A/S; 2010. 6. Carac® (fluorouracil) Cream, 0.5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals; 2012. 7. Efudex® (fluorouracil) topical solutions and cream [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2012. 8. Zyclara® (imiquimod) Cream, 3.75% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 9. Aldara® (imiquimod) Cream, 5% [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2014. 10. Solaraze® (diclofenac sodium) Gel, 3% [prescribing information]. Melville, NY: PharmaDerm; 2012. 11. Picato® [prescribing information]. Instructions for Use. Madison, NJ: LEO Pharma Inc.
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.

Terms and Conditions and Eligibility Requirements:
1. This card is good for use only with a valid prescription for Enstilar® (calcipotriene and betamethasone dipropionate) Foam 0.005%/0.064%, Picato® (ingenol mebutate) gel 0.015%, 0.05%, or Finacea® (azelaic acid) Foam 15%. 2. This card is valid for up to 12 prescription fills per calendar year, up to a maximum benefit of $6000 per year for Enstilar®, Picato®, and up to a maximum benefit of $1200 per year for Finacea Foam®. 3. For patients with commercial health insurance, this card may reduce out-of-pocket expenses. 4. Offer good only in the USA at participating pharmacies. 5. Original card must be presented to the pharmacist at the time the prescription is filled. Not valid if reproduced. 6. Only one card per patient. 7. The selling, purchasing, trading, or counterfeiting of this card is prohibited by the law. 8. Card is not transferable. 9. You must be 18 years of age or older to use this card. If you are under 18, a legal guardian over 18 years of age may access this program on your behalf where permitted by, and consistent with, additional restrictions imposed by law (and subject to any additional age restrictions that relate to each product). 10. This card is not health insurance. 11. You are responsible for the use of this card and for complying with reporting obligations, if any, of your insurance plan. 12. Patient is not eligible to participate in the program or use the card if enrolled in or eligible for any state or federally funded programs, including, but not limited to, Medicare (including Medicare Part D), Medicaid, Medigap, VA, DOD, TriCare, or CHIP. 13. Offer void where prohibited by law, taxed, or restricted. 14. Not valid in combination with any other offers, discounts, or programs. 15. Card has no cash value. 16. LEO Pharma Inc. reserves the right to rescind, revoke, or amend this offer without notice. 17. You understand and agree to the terms and conditions as set forth above.

Full details of the LEO Pharma® CONNECT program may be obtained by calling 1-877-678-7494 between 8:30 AM and 8:30 PM (Eastern), Monday through Friday.

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