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IMPORTANT SAFETY INFORMATION

What is Picato® gel?

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

Picato® gel, 0.05% is a prescription medicine used on the skin to treat actinic keratosis on the body or arms and legs.

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

Picato gel is for use on the skin only (topical). Do not use Picato gel in, around, or near your eyes, mouth, lips, or vagina.

Who should not use Picato gel?

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

What should I discuss with my healthcare provider before using Picato gel?

Tell your healthcare provider about all your medical conditions, including if you:

  • are being treated or have been treated for actinic keratosis with other medicines or surgery. You should not use Picato gel until your skin has healed from other treatments.
  • have other skin problems or sunburn in the treatment area.
  • are pregnant or plan to become pregnant. It is not known if Picato gel can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. If you use Picato gel while breastfeeding, make sure that your treated skin does not come into contact with the infant.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I use Picato gel?

Read the Instructions for Use that comes with Picato gel. There you will find information about how to apply and store Picato gel.

Use Picato gel exactly as your healthcare provider tells you.

Do not use more Picato gel than you need to cover the treatment area. Using too much or using it too often or for too long can increase your chances for having a severe skin reaction or other side effects.

Wash your hands well with soap and water after applying Picato gel.

If you accidentally get Picato gel in your eyes, flush them with large amounts of water and get medical care as soon as possible.

What are the possible side effects of Picato gel?

Picato gel may cause serious or severe side effects including:

  • Eye problems can happen if Picato gel gets in your eyes. Eye problems may include severe eye pain, swelling or drooping of your eyelids, or swelling around your eyes.
  • Serious allergic reactions. Serious allergic reactions have happened with Picato gel, and in some cases have required treatment in a hospital. Get medical help right away if you get any of the following symptoms of a serious allergic reaction:
    • swelling of lips or tongue
    • chest tightness
    • trouble breathing or wheezing
    • dizziness or passing out
  • Local skin reactions. Skin reactions in the treatment area are common with Picato gel. You may get a skin reaction such as mild redness, flaking or scaling, crusting or swelling. You may also see changes in your skin color (pigmentation changes) and scarring where Picato gel is applied.
  • Severe skin reactions. A rare, severe skin reaction (Stevens-Johnson Syndrome) may occur without warning requiring immediate medical attention. Call your healthcare provider if you get skin redness, flaking or scaling, crusting, or swelling that is more severe, or if you get blisters, pus, ulcers or breakdown of your skin.

The most common side effects include local skin reactions, pain, itching, or skin irritation at the treatment area, infection at the treatment area, swelling around the eyes, nose and throat irritation and headache. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

Where do I learn more?

This summary does not include all the information about Picato gel. Read the information that comes with your prescription every time you have a prescription filled. Talk to your healthcare provider or pharmacist about this information. Your healthcare provider is the best person to help you decide if Picato gel is right for you.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/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 Picato Full Prescribing Information.

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%, Finacea® (azelaic acid) Foam 15%, or Desonate® (desonide) Gel 0.05%. 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®, or Picato®, up to a maximum benefit of $1200 per year for Finacea Foam® and up to a maximum benefit of $2400 per year for Desonate®. 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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