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Ingenol Mebutate

Pronunciation: IN-je-nol MEB-ue-tate
Class: Immunomodulator, topical

Trade Names

Picato
- Gel, topical 0.015%
- Gel, topical 0.05%

Pharmacology

Mechanism by which ingenol induces cell death is unknown.

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Pharmacokinetics

Absorption

Blood levels were below the lower limit of quantification (0.1 ng/mL).

Indications and Usage

Treatment of actinic keratosis.

Contraindications

None well documented.

Dosage and Administration

Actinic Keratosis
Adults 0.015%

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.

General Advice

  • 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.

Storage/Stability

Store refrigerated between 36° and 46°F. Protect from freezing. Discard tubes after a single use.

Drug Interactions

None known.

Adverse Reactions

CNS

Headache (2%).

EENT

Periorbital edema (3%); nasopharyngitis (2%); conjunctivitis, eyelid edema, eyelid pain.

Local

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%).

Precautions

Monitor

Periodically assess response to therapy.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in patients younger than 18 y have not been established.

Eye exposure

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.

Overdosage

Symptoms

Local skin reactions.

Patient Information

  • 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.

Copyright © 2009 Wolters Kluwer Health.

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