Monograph
D06BX02 - Ingenol Mebutate |
Not porphyrinogenic |
NP |
Rationale
Ingenol mebutate is applied topically and systemic exposure is insignificant.
Chemical description
Diterpene ester
Therapeutic characteristics
Ingenol mebutate is used in the topical treatment of actinic keratosis. The gel is applied once daily to the affected skin area for two or three consecutive days.
Hepatic exposure
Ingenol mebutate 0.5 % gel was applied to a 100 cm2 application area, once daily for two consecutive days, the systemic exposure was less than 0.1 ng/mL and regarded as not quantifiable (Anderson 2014).
Metabolism and pharmacokinetics
Ingenol mebutate is applied topically and is not absorbed systemically (SPC). It is not suspected to be an inducer or an inhibitor of CYP450 enzymes in vitro (Keating 2012).
No interaction studies have been performed (SPC).
References
| # | Citation details | PMID |
|---|---|---|
| * | Scientific articles | |
| 1. | Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis.
Anderson L, Jarratt M, et al. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29. |
|
| 2. | Ingenol mebutate gel 0.015% and 0.05%: in actinic keratosis.
Keating GM. Drugs. 2012 Dec 24;72(18):2397-405 |
|
| * | Summary of Product Characteristics | |
| 3. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). (Picato).
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