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