ingenol mebutate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
ingenol mebutate: clinical details
Prescribing considerations
- Do not prescribe or supply: the UK licence was suspended and stock recalled in 2020.
- Review previously exposed patients promptly if new lesions arise within the treated field; onset has ranged from weeks to months.
- Biopsy lesions that are atypical for actinic keratosis or suspicious for malignancy.
- Clinical experience in immunocompromised patients was unavailable.
Contraindications and cautions
- Hypersensitivity to ingenol mebutate or any excipient.
- Current regulatory status precludes routine UK prescribing.
Monitoring
- No routine laboratory monitoring was specified.
- Monitor treated skin for excessive local reactions, infection and suspicious new lesions.
- Assess accidental eye exposure urgently.
Clinical pharmacology
Ingenol mebutate produced local lesion-cell death and a cytokine-driven inflammatory response. Blood concentrations were not quantifiable after studied topical exposure, and in-vitro testing found no inhibition or induction of major CYP450 isoenzymes.
Formulation and product differences
- The selected historical product was a clear, colourless gel supplied in single-use tubes for face or scalp treatment fields.
- A separate higher-concentration presentation was formerly intended for trunk and limb treatment fields; the formulations were not interchangeable between sites.
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.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.