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Bookshelf ID: NBK565976PMID: 33355739
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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 75567-37-2
Drug Levels and Effects
Summary of Use during Lactation
Topical ingenol mebutate has not been studied during breastfeeding. However, after topical administration, serum concentrations were undetectable, so breastfeeding is not expected to result in exposure of the breastfed infant. If ingenol mebutate is required by the mother, it is not a reason to discontinue breastfeeding. Do not apply ingenol mebutate to the breast or nipple and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.
Drug Levels
Maternal Levels. According to the manufacturer, serum concentrations of ingenol mebutate and its two metabolites are below the limit of detection (<0.1 mcg/L) after topical application of approximately 1 gram of 0.05% gel to an area of 100 sq. cm.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Substance Identification
Substance Name
Ingenol Mebutate
CAS Registry Number
75567-37-2
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
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- PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study.[Australas J Dermatol. 2009]PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study.Siller G, Gebauer K, Welburn P, Katsamas J, Ogbourne SM. Australas J Dermatol. 2009 Feb; 50(1):16-22.
- Review Ingenol mebutate: a promising treatment for actinic keratoses and nonmelanoma skin cancers.[J Cutan Med Surg. 2013]Review Ingenol mebutate: a promising treatment for actinic keratoses and nonmelanoma skin cancers.Gupta AK, Paquet M. J Cutan Med Surg. 2013 May-Jun; 17(3):173-9.
- Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis.[J Am Acad Dermatol. 2009]Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis.Anderson L, Schmieder GJ, Werschler WP, Tschen EH, Ling MR, Stough DB, Katsamas J. J Am Acad Dermatol. 2009 Jun; 60(6):934-43.
- Review Topical Ingenol Mebutate: A New Treatment Modality for Multiple Actinic Keratoses and Field Cancerization.[Anticancer Agents Med Chem. 2017]Review Topical Ingenol Mebutate: A New Treatment Modality for Multiple Actinic Keratoses and Field Cancerization.Kostovic K, Gulin SJ, Mokos ZB, Ceovic R. Anticancer Agents Med Chem. 2017; 17(10):1304-1311.
- Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers.[J Clin Aesthet Dermatol. 2014]Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers.Dosik JS, Damstra M, Udell C, Welburn P. J Clin Aesthet Dermatol. 2014 Apr; 7(4):35-42.
- Ingenol Mebutate - Drugs and Lactation Database (LactMed®)Ingenol Mebutate - Drugs and Lactation Database (LactMed®)
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