Ingenol Mebutate

Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: IM900
Chemical Name: (2Z)-(1aR,2S,5R,5aS,6S,8aS,9R,10aR)-1a,2,5,5a,6,9,10,10a-octahydro-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1H-2,8a-methanocyclopenta[a]cyclopropa[e]cyclodecen-6-yl-2-methyl-2-butenoic acid ester
Molecular Formula: C₂₅H₃₄O₆
CAS Number: 75567-37-2
Brands: Picato

Medically reviewed by Drugs.com on Mar 21, 2022. Written by ASHP.

Introduction

Macrocyclic diterpene ester; inducer of cell death.

Uses for Ingenol Mebutate

Actinic Keratosis

Treatment of actinic keratosis lesions on the face and scalp (0.015% gel) or on the trunk and extremities (0.05% gel).

Appears to have similar efficacy as other topical treatments (e.g., fluorouracil, imiquimod, diclofenac) with a shorter duration of treatment (2–3 days versus 4–16 weeks); however, clinical studies that directly compare the safety and efficacy of these drugs are needed.

When selecting a regimen for treatment of actinic keratoses (e.g., topical drug therapy, photodynamic therapy, cryotherapy), consider the number of lesions, the individual patient's desired outcome (e.g., cosmetic effects, relief of associated symptoms, prevention of skin cancer), and adverse effects associated with the regimen.

Ingenol Mebutate Dosage and Administration

Administration

Topical Administration

Apply topically as a 0.015 or 0.05% gel.

For external use only. Do not administer orally, vaginally, or topically to the lips or eyes.

FDA has received reports of severe eye injuries and skin reactions associated with the application of the drug; some cases were associated with application of the gel jn a manner other than that recommended in the product labeling. (See Cautions: Warnings/Precautions and see Advice to Patients.)

Apply evenly to affected area, up to one contiguous area of skin approximately 25 cm². Wash hands immediately after applying ingenol mebutate gel.

Allow gel to dry for 15 minutes; avoid washing or touching the treated area for 6 hours after application. After 6 hours, may wash area with a mild soap.

Dosage

Adults

Actinic Keratosis

Actinic Keratosis of the Face and Scalp

0.015% Gel: Apply evenly to affected area once daily for 3 consecutive days.

Actinic Keratosis of the Trunk and Extremities

0.05% Gel: Apply evenly to affected area once daily for 2 consecutive days.

Prescribing Limits

Adults

Actinic Keratosis

Topical

Use only enough gel to cover the treatment area (≤1 single-use tube per application); do not use more often or for longer than instructed.