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:
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:
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 firstname.lastname@example.org.