Pronunciation: IN-je-nol MEB-ue-tate
Class: Immunomodulator, topical
- Gel, topical 0.015%
- Gel, topical 0.05%
Mechanism by which ingenol induces cell death is unknown.
Blood levels were below the lower limit of quantification (0.1 ng/mL).
Indications and Usage
Treatment of actinic keratosis.
None well documented.
Dosage and AdministrationActinic Keratosis
Topical Apply once daily to the affected area of the face and scalp for 3 consecutive days.0.05%
Topical Apply once daily to the affected area of the trunk and extremities for 2 consecutive days.
- For topical use only. Not for ophthalmic, oral, or intravaginal use.
- Apply to the affected area, up to 1 contiguous skin area of approximately 25 cm 2 , using 1 unit dose tube. Allow the gel to dry for 15 min after application.
- Patients should wash their hands immediately after application and take care not to transfer the applied drug to other areas, including the eye.
- Avoid washing or touching the treated area for 6 h after application; after that, the area may be washed with a mild soap.
Store refrigerated between 36° and 46°F. Protect from freezing. Discard tubes after a single use.
Periorbital edema (3%); nasopharyngitis (2%); conjunctivitis, eyelid edema, eyelid pain.
Erythema (94%); flaking/scaling (90%); crusting (80%); swelling (79%); vesiculation/pustulation (56%); erosion/ulceration (32%); application-site pain (15%); application-site pruritus (8%); application-site irritation (4%); application-site infection (3%).
Periodically assess response to therapy.
Category C .
Safety and efficacy in patients younger than 18 y have not been established.
Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, and periorbital edema, can occur after exposure. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible.
Local skin reactions
Severe skin reactions in the treated area can occur. Administration is not recommended until the skin is healed from any previous drug or surgical treatment.
Local skin reactions.
- Advise patient that ingenol is for external use only and to avoid contact with the eyes.
- Inform patient that treatment with ingenol may lead to local skin reactions.
- Advise patient to avoid inadvertent transfer of ingenol to other areas or to another person.
- Instruct patient to allow the treated area to dry for 15 min after application. Instruct patient to avoid washing and touching the treated area or participating in activities that cause excessive sweating for 6 h after treatment. Following this time, advise patient that the area may be washed with a mild soap.
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