ingenol mebutate at a glance
Medicine class
Topical dermatological chemotherapeutic agent
Former licensed use
Non-thickened, non-raised actinic keratoses in adults
Current status
Licence suspended, UK stock recalled and product discontinued
Administration route
Applied to the skin; eye, mouth and mucosal contact had to be avoided
What is ingenol mebutate used for?
Ingenol mebutate is no longer a current UK treatment option.
Its former UK indication was topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
How does ingenol mebutate work?
Its action was not fully characterised. It caused local death of abnormal lesion cells and stimulated a strong local inflammatory response involving cytokines and immune cells.
How to take ingenol mebutate
Do not start or continue ingenol mebutate from old stock. Historically, the gel was spread evenly over the prescribed skin field, allowed to dry and followed by immediate handwashing.
Avoid the eyes, lips, inside of the nose or ears, open wounds and damaged skin.
Do not cover treated skin with an airtight or watertight dressing.
Discard a single-use tube after opening.
ingenol mebutate side effects
Common or expected effects
- Application-site redness, swelling, peeling and scabbing
- Blisters, pustules or superficial skin erosion
- Application-site pain or burning
- Itching or irritation
- Headache after face or scalp treatment
Get urgent medical advice
- Allergic reaction, including angioedema
- Chemical conjunctivitis or corneal burn after eye exposure
- Possible application-site infection, particularly with worsening inflammation or discharge
- New skin tumours or suspicious lesions in the treated area
ingenol mebutate in pregnancy
Human pregnancy data were unavailable, and former product information advised avoiding use during pregnancy as a precaution. Discuss any past exposure with the relevant clinician.
ingenol mebutate while breastfeeding
Systemic absorption was considered negligible, so effects on a breastfed infant were not anticipated. Former instructions required preventing the infant from touching treated skin. The product is no longer a current UK treatment option.
ingenol mebutate interactions
No interaction studies were performed. Interactions with systemically absorbed medicines were considered unlikely because measurable systemic absorption was not detected after topical use.
Common questions about ingenol mebutate
Answers are fully visible for fast scanning and source review.
Is ingenol mebutate still available in the UK?
No. Its licence was suspended, UK stock was recalled in 2020 and the product is listed as discontinued.
Why was it taken off the market?
Clinical evidence showed more skin tumours in treated areas than with comparator treatment. The European review concluded that the risks outweighed the benefits.
What was it used to treat?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.