What to expect


In clinical studies (N=985), partial or complete clearance was seen in patients by Week 8 (Day 57)*

  • Picato® can cover multiple lesions, treating a continuous area of up to 2x2 inches or 25 cm2
  • In a clinical study on the face and scalp, Picato® effectively treated new, emergent, and recurrent AK lesions

Consider Picato® for the treatment of AK

  • * Complete clearance was defined as the percentage of patients with 100% clearance of all AKs in the field, whether present or emergent during treatment, assessed at Day 57 (P<0.001). Partial clearance as defined as the percentage of patients with ≥75% clearance of all AKs in the field, whether present or emergent during treatment, assessed at Day 57 (P<0.001).
  • In studies with Picato®, results were measured at Week 8 (Day 57).

Important Safety Information

Reports of hypersensitivity reactions (anaphylaxis and allergic contact dermatitis) and herpes zoster (shingles) have been received during post approval use of Picato®.

See additional Important Safety Information.

Treatment on the face and scalp in actual patients treated with Picato®

Face and scalp

  • Patient 1 | MILD
  • Patient 2 | MODERATE
  • Patient 3 | SEVERE
Patient 1 | MILD
  • Patient 1 | MILD
  • Patient 2 | Moderate
  • Patient 3 | Severe
SCALP
Before Treatment
Local Skin reactions from Picato treatment on the face and scalp
57 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
4 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
8 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
15 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
Before Treatment
Local Skin reactions from Picato treatment on the face and scalp
4 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
8 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
15 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
57 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
FACE
Before Treatment
Local Skin reactions from Picato treatment on the face and scalp
57 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
4 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
8 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
15 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
Before Treatment
Local Skin reactions from Picato treatment on the face and scalp
4 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
8 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
15 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
57 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
FACE
Before Treatment
Local Skin reactions from Picato treatment on the face and scalp
57 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
4 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
8 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
15 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
Before Treatment
Local Skin reactions from Picato treatment on the face and scalp
4 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
8 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
15 Days After Start
Local Skin reactions from Picato treatment on the face and scalp
57 Days After Start
Local Skin reactions from Picato treatment on the face and scalp

These images represent a range of skin reactions, from mild to severe, experienced by patients treated in 2 actinic keratosis clinical trials on the face and scalp. Individual results may vary. Consult your healthcare provider if symptoms persist or become more severe.

Important Safety Information

The most common side effects with Picato® gel on the face and scalp (≥2%) include skin reactions in the treatment area (94%), pain at the treatment area (15%), itching at the treatment area (8%), infection at the treatment area (3%), swelling around your eyelids (3%), and headache (2%).

See additional Important Safety Information.

Treatment on the body, arms, and legs in actual patients treated with Picato®

Body, arms, and legs

  • 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

These images represent a range of skin reactions, from mild to severe, experienced by patients treated in 2 actinic keratosis clinical trials on the body, arms, and legs. Individual results may vary. Consult your healthcare provider if symptoms persist or become more severe.

Important Safety Information

The most common side effects with Picato® gel on the body, arms, and legs (≥2%) include skin reactions in the treatment area (92%), itching at the treatment area (8%), skin irritation at the treatment area (4%), nose and throat irritation (2%), and pain at the treatment area (2%).

See additional Important Safety Information.

Most patients experienced mild to moderate skin reactions in clinical studies. However, some patients experienced severe skin reactions, including redness, flaking or scaling, crusting, swelling, blistering, pus, ulcers, or breakdown of skin.

If you feel that you are suffering from a severe skin reaction, talk to your healthcare professional.

With Picato®, skin reactions occur as early as Day 1

Skin reactions occur in most patients after the first dose, and vary from patient to patient. ‭Following treatment skin reactions may occur, including redness, flaking or scaling, crusting, swelling, blisters, pus, ulcers, or breakdown of your skin. ‭You may also see changes in your skin color (pigmentation ‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬changes) and scarring where Picato® gel is applied. Consult your healthcare professional if the symptoms persist, become more severe, or if you develop blisters, pus, ulcers, or breakdown of your skin.‬‬‬‬

Contact a dermatologist today to discuss AK treatment

Indication

Picato® (ingenol mebutate) gel, 0.015%, 0.05% is prescription medicine used on the skin to treat actinic keratosis.

Important Safety Information

Do not use Picato® gel if you are allergic to ingenol mebutate or any of the ingredients in Picato® gel.

Eye problems, including severe eye pain, swelling or drooping of your eyelids, corneal burn, redness, swelling and irritation inside the eye, or swelling around your eyes can happen if Picato® gel gets in your eyes. To avoid getting any of the Picato® into or around the eyes, it is important that you wash your hands well with soap and water after applying Picato® gel and be careful to keep Picato® gel on the treated area from coming into contact with your eyes. If you accidentally get Picato® gel in your eyes, flush them with large amounts of water and get medical care as soon as possible.

There have been reports of serious allergic reactions (hives, itching, flushing and swelling of the lips or tongue, trouble breathing or wheezing, chest tightness and dizziness or passing out) in patients using Picato®. The frequency of these events or their relationship, if any, to treatment with Picato® is unknown. If you experience any such symptoms, discontinue Picato® immediately and seek emergency medical help.

For use on the skin only. Picato® can be applied to a contiguous skin area of approximately 25 cm2 (5 cm x 5 cm). Do not use Picato® in, around, or near your eyes, mouth, lips, or vagina.

Reports of hypersensitivity reactions (anaphylaxis and allergic contact dermatitis) and herpes zoster (shingles) have been received during post approval use of Picato®.

Severe skin reactions in the treated areas on the face/scalp and body/arms/legs, including redness, flaking or scaling, crusting, swelling, blisters, pus, ulcers or breakdown of your skin can happen after applying Picato®. You may also see changes in your skin color (pigmentation changes) and scarring where Picato® gel is applied. You should not use Picato® gel until your skin has healed from other treatments or surgeries. The most common side effects with Picato® gel on the face and scalp (≥2%) include skin reactions in the treatment area (94%), pain at the treatment area (15%), itching at the treatment area (8%), infection at the treatment area (3%), swelling around your eyelids (3%), and headache (2%). The most common side effects with Picato® gel on the body, arms and legs (≥2%) include skin reactions in the treatment area (92%), itching at the treatment area (8%), skin irritation at the treatment area (4%), nose and throat irritation (2%), and pain at the treatment area (2%).

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Picato® gel can harm your unborn baby.

It is also not known if Picato® is safe and effective for the treatment of actinic keratosis in children less than 18 years of age.

You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/Safety/MedWatch.

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 see Picato® Full Prescribing Information.

Eligibility criteria: 1. This card is good for use only with a valid prescription for Picato®. 2. This card is valid for up to 12 ‭prescription fills per calendar year for Picato®. 3. For patients with commercial health insurance, this card may reduce out-of-pocket expenses. 4. Offer good only in the USA at participating retail 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 law. 8. Card is not transferable. 9. You must be 18 years of age or older to use this card with your Picato® prescription. 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. You may not use this card if you are enrolled in any state or federal healthcare program, including Medicaid, Medicare ‭(including Medicare Part D), Medigap, VA, DoD, TRICARE or Chip, unless not eligible for drug coverage in whole or in part. 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 Franchise Card Program may be obtained by calling 1-855-820-9627 (Monday - Friday, 8:00 ‭AM‭-8:00 ‭PM ET) or visiting www.activatethecard.com/LEO.

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