A substance found in garden spurge and belonging to the chemical group of diterpenes(terpenes). Ingenol mebutate was used as a medicinal substance in gel form for the topical treatment of actinic keratoses. Ingenol mebutate belongs to the esters of a group of diterpenes (ingenanes, tigliane, daphnanes).
Ingenolmebutate
DefinitionThis section has been translated automatically.
Pharmacodynamics (Effect)This section has been translated automatically.
On the one hand, the active substance proves to be cytotoxic, on the other hand the substance initiates a neutrophil-mediated immune reaction. The substance stimulates the protein kinase-C-dependent cytokine release (IL-8 and TNF-alpha).
Field of application/useThis section has been translated automatically.
- No longer approved since 2020.
- in advance:
- Short-term therapy for the facial area: apply the 0.015% gel once a day for 3 days.
- For extremities and trunk, the higher-dose 0.05% gel is applied once a day for 2 days.
IndicationThis section has been translated automatically.
before 2020: Actinic keratoses
Dosage and method of useThis section has been translated automatically.
Ingenolmebutate was used as a drug in gel form for the topical treatment of actinic keratoses.
Undesirable effectsThis section has been translated automatically.
Local skin irritation, which tends to be classified as moderate to mild. The therapy-induced skin reactions reach their maximum between the 4th and 8th day. They subside completely after 2-4 weeks. Systemic reactions (caused by absorption of the active substance) are not to be expected.
Induction of squamous cell carcinoma: After 3 years, 6.3 % of patients treated with Picato® (15 out of 240 patients) developed skin cancer in the treated skin areas, especially squamous cell carcinoma.
PreparationsThis section has been translated automatically.
Trade name, no longer authorized: Picato®
Red Hand Letter for Picato (ingenol mebutate) - January 2020
27.01.2020 - With this Red Hand Letter, the manufacturer informs about the suspension of the marketing authorization of Picato (ingenol mebutate) due to the risk of malignant skin lesions.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA ) has completed its review of Picato® with the conclusion that the medicine may increase the risk of skin cancer and that the risks outweigh the benefits.
Note(s)This section has been translated automatically.
A gel containing ingenol mebutate has been approved in the USA since January 2012 and in EU countries since November 2012.
In 2020, approval was withdrawn in Europe because an increased risk of skin cancer was observed during treatment.
PatientinformationThis section has been translated automatically.
In Australian folk medicine, the sap of the garden spurge is known to be effective against warts and "skin tumors".
Experimental: Successful treatments for condylomata acuminata have been reported (single dabbing of the papillomas with Picato ingenol mebutate gel).
LiteratureThis section has been translated automatically.
- Gellrich FF et al. (2014) Ingenolmebutate for the treatment of actinic keratosis in routine outpatient care. Act Dermatol 40: 340-346
- Lebwohl M et al. (2012) Ingenol mebutate gel for actinic keratosis. N Engl J Med 366:1010-1019
- Braun SA et al. (2015) Successful therapy of condylomata acuminata with ingenol mebutate. Dermatologist 66: 223-225
- https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RV_STP/m-r/picato.html