About actinic keratosis (AK)

AK is a common, chronic condition that affects millions of people

AK is a skin condition marked by scaly, rough patches of skin. These patches appear over time, primarily caused by too much sun exposure. If you notice "sun spots" on your skin, and spend lots of time in the sun, visit your dermatologist to determine if you have AK.

If you're diagnosed with AK, you’re in the company of millions of other patients. AK is one of the most common skin disorders in people with fair skin. It is also chronic and recurring—if patches of rough skin begin to appear now, there’s a chance that more patches will appear in the future. This is why it is important to treat lesions as they arise. Once diagnosed by a healthcare professional, AK can be treated using a variety of methods.

Recognizing AK

AK lesions can appear anywhere on skin that has been exposed to the sun, but they’re usually found on the face, lips, ears, hands, arms, scalp, neck, and chest. They often feel different from normal skin, with a scaly or flaky texture. Lesions can also itch, burn, or irritate skin. Lesions themselves appear differently depending on the patient—common types are shown below.

Understanding the AK field

If there are multiple AK lesions in an area, that’s called the field. Picato® is a topical treatment that can cover an AK field, up to a continuous area of about 2x2 inches or 25 cm2. Your dermatologist will be able to determine if you have AK and discuss your treatment options.

Risk factors for AK

While it’s important to discuss any concerns with a dermatologist, there are several factors that may increase the risk for developing AK. This condition usually affects people with:

Pale or fair skin

Light-colored hair

Light-colored eyes

Not actual patients.

Additionally, since AK is caused by sun exposure over a long period of time, it's most likely to be found in people who are 40 and older. However, younger people may also be affected.

Treating AK

Since AK is a chronic condition that often returns, it’s important to treat patches as they appear.

One method of treating AK is medication, prescription products that are applied to areas of skin affected by AK. Another is photodynamic therapy, in which a healthcare professional applies a chemical solution to patches of skin that make your skin sensitive to light. The skin is then exposed to light to destroy damaged skin cells. Surgery is also an option, such as freezing AKs (cryotherapy) or scraping them off (curettage).

Every therapy will have its advantages and tradeoffs, so be sure to talk with your dermatologist about which method is best for you.

Think you’re at risk?

Ask your dermatologist about AK.

Find a list of dermatologists in your area.

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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