Picato (ingenol mebutate)

Picato gel may cause serious or severe side effects including:

• Eye problemscan happen if Picato gel gets in your eyes.Eye problems may include severeeye pain, swelling or drooping of your eyelids, or swelling around your eyes. If you accidentally get Picato gel in your eyes,flushthem with large amounts of water and get medical care as soon as possible.
• Seriousallergicreactions.Serious allergic reactions have happened with Picato gel, and in some cases have required treatment in a hospital. See “Who should not use Picato gel?”. Get medical help right away if you get any of the following symptoms of a seriousallergic reaction:
  • swelling of the lips or tongue
  • troublebreathingorwheezing
  • chest tightness
  • dizzinessor 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. Call your healthcare provider if you get skin redness, flaking or scaling, crusting, or swelling that is more severe, or if you getblisters, pus, ulcers or breakdown of your skin.

最常见的副作用与Picato凝胶include:

• local skin reactions, see “Local skin reactions” above
• pain,itching, or skin irritation at the treatment area
• infection at the treatment area
• swelling around the eyes
• 鼻子和喉咙发炎
• 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 of Picato gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to LEO Pharma Inc. at 1-877-494-4536.

• For the treatment of actinic keratosis on the face or scalp Picato gel, 0.015% should be applied to the affected area once daily for 3 consecutive days.
• For the treatment of actinic keratosis on the trunk or extremities Picato gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.
• Picato gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm² (e.g., 5 cm x 5 cm) using one unit dose tube. After spreading evenly over the treatment area, the gel should be allowed to dry for 15 minutes. Patients should wash their hands immediately after applying Picato gel and take care not to transfer the applied drug to other areas, including the eye. Patients should avoid washing and touching the treated area for a period of 6 hours after application of Picato gel. Following this time, patients may wash the area with a mild soap.
• Avoid transfer of Picato gel to periocular area.
• Avoid application near and around the mouth and lips.
• For topical use only.Vantas is not for oral, ophthalmic, or intravaginal use.

• There are no available data on Picato gel use inpregnantwomen to evaluate a drug-associated risk of majorbirth defects,miscarriage, or adverse maternal or fetal outcomes.
• There are no data on the presence of ingenol mebutate in human or animal milk, the effects on thebreastfedinfant or the effects on milk production.
• The developmental and health benefits ofbreastfeedingshould be considered along with the mother's clinical need for Picato gel and any potential adverse effects on the breastfed infant from Picato gel or from the underlying maternal condition.