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Ingenol mebutate

Brand and Other Names: Picato
Mechanism of Action:
Indications:
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Warnings and Precautions:
Description:

Withdrawn from US/EU markets in 2017 due to safety concerns. 

GOOGLE OVERVIEW

Ingenol mebutate, marketed as Picato, is a topical medication used to treat actinic keratosis (AK), a precancerous skin condition. It works by inducing cell death in the affected area and is applied as a gel, with different strengths for the face/scalp and trunk/extremities. While effective, it carries a risk of severe skin reactions and potential links to skin cancer, leading to its withdrawal from the market in some regions. 
 
Key Points:
  • What it is:
    Ingenol mebutate is a diterpene ester derived from the sap of the Euphorbia peplus plant. 
     
How it works:
It induces cell death in abnormal skin cells associated with actinic keratosis and triggers an inflammatory response. 
 
Treatment:
It's available as a topical gel in two strengths: 0.015% for the face and scalp, and 0.05% for the trunk and extremities. 
 
Application:
The 0.015% gel is applied once daily for 3 days, while the 0.05% gel is applied once daily for 2 days. 
 
Side effects:
Common side effects include skin reactions at the application site, such as redness, itching, and irritation. 
 
Risks:
There have been reports of severe skin reactions and an increased risk of skin cancer (specifically squamous cell carcinoma) in the treated area compared to other treatments. 
 
Market withdrawal:
Due to the increased risk of skin cancer, ingenol mebutate was withdrawn from the European market and other regions. The FDA also issued warnings about potential severe adverse events. 
 
Current status:
While still available in some areas, it's crucial to be aware of the potential risks and weigh them against the benefits, especially in light of the market withdrawal in other regions. 
 
 

 

See package insert for full prescribing information.