Ingenol mebutate
Brand names: Picato
Ingenol mebutate was a topical gel formerly used for actinic (solar) keratoses on the face, scalp, trunk and extremities.
ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.
Clinical monograph
How it works
Derived from Euphorbia peplus sap, it induces rapid lesional cell death and a neutrophil-mediated inflammatory response that clears dysplastic keratinocytes.
Prescribing in practice
- Marketing authorisation was suspended and the product withdrawn after data suggested a possible increased risk of skin malignancy at treated sites, so it should no longer be prescribed; use an alternative field therapy.
- Where historically used, intense local skin reactions including erythema, flaking, crusting and vesiculation were expected over the short treatment course.
- Patients previously treated should have treated areas monitored for new or changing skin lesions.
Monitoring
Patients who received this agent should have the treated skin kept under surveillance for new or suspicious lesions; check current MHRA advice before any use.
Counselling the patient
- This treatment has been withdrawn over a possible skin cancer concern and is no longer used.
- If you used it in the past, report any new or changing skin spots to your clinician.
- Ask your clinician about alternative treatments for sun-damage skin patches.
Evidence & guidelines
Following an EMA/MHRA safety review, ingenol mebutate's authorisation was suspended and the product withdrawn due to concerns about increased skin cancer risk at application sites.
Reference: MHRA Drug Safety Update Jan 2020; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
- Suspicious Pigmented Lesion — Melanoma Pathway · NICE NG14 2015 / BAD
- Cellulitis and Erysipelas · NICE NG141 2019 / CREST
- Psoriasis — Severity Assessment and Step-Up Therapy · NICE NG153 2019 / BAD
- Atopic Eczema — Assessment and Step-Up Therapy · NICE NG95 2023
- Urticaria and Angioedema · BSACI / EAACI Guidelines 2022
- Acne Vulgaris — Grading and Treatment · NICE NG198 2021 / BAD