ingenol

ingenol

(in-je-nol) ,

Picato

(trade name)

Classification

Therapeutic: actinic ketatosis agents
Pharmacologic: cell death inducers
Pregnancy Category: C

Indications

Topical treatment of actinic keratoses.

Action

Acts as an inducer of cell death.

Therapeutic effects

Irritative reaction followed by improvement/resolution of actinic keratotic lesions.

Pharmacokinetics

Absorption: Negligible absorption follows topical use.
Distribution: Unknown.
Metabolism and Excretion: Undergoes extensive metabolism in hepatocytes.
Half-life: Unknown.

Time/action profile (local skin reactions)

ROUTEONSETPEAKDURATION†
Topwithin 1 day1 wk following completion of treatment2 wk (face and scalp), 4 wk (trunk and extremities)
† Resolution of lesions.

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Should not be applied to the periocular area; Obstetric: Use during pregnancy only if potential benefit justifies potential risk to the fetus; Pediatric: Condition not seen in pediatric population, safe and effective use has not been established in patients <18 yr.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Local

  • crusting (most frequent)
  • erosion/ulceration (most frequent)
  • erythema (most frequent)
  • flaking/scaling (most frequent)
  • swelling (most frequent)
  • vesiculation/pustulation (most frequent)
  • application site pain
  • irritation
  • pruritus

Interactions

Drug-Drug interaction

None noted

Route/Dosage

Actinic keratosis of the face and scalp

Topical (Adults) Apply 0.015% gel to affected area (within a 25 cm2 contiguous area) once daily for 3 consecutive days.

Actinic keratosis of the trunk and extremities

Topical (Adults) Apply 0.05% gel to affected area (within a 25 cm2 contiguous area) once daily for 2 consecutive days.

Availability

Gel for topical use: 0.015% in 0.25 g single-use tubes, 0.05% in 0.25 g single-use tubes

Nursing implications

Nursing assessment

  • Assess skin before and periodically during therapy.

Potential Nursing Diagnoses

Risk for impaired skin integrity (Indications)

Implementation

  • Topical: For face and scalp: Apply 0.015% gel to affected area once daily for 3 consecutive days. For trunk and extremities: Apply 0.05% gel to affected area once daily for 2 consecutive days.
    • Open a new tube of gel for each application, then discard. Store tubes in refrigerator; do not freeze. After spreading evenly over area, allow to dry for 15 min. Do not cover with bandages or other closed dressings. Wash hands immediately after applying. Do not apply to mouth, eyes, or vaginal areas. Avoid transfer of applied drug to other areas. Avoid washing and touching area for at least 6 hr after application. After 6 hrs, may wash with mild soap.

Patient/Family Teaching

  • Instruct patient on correct technique for application. Do not apply right after taking a shower or less than 2 hrs before bedtime. Do not apply more than needed to cover treatment area. Using too much or for too long may cause severe skin reactions.
  • Inform patient that gel application may cause local skin reactions (mild redness, flaking, scaling, crusting, swelling). Notify health care professional if reaction is severe or if blisters, pus, ulcers, or breakdown of skin occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Resolution of actinic keratoses.
References in periodicals archive ?
Options include 5-FU (5-fluorouracil), imiquimod, ingenol mebutate, and photodynamic therapy as well as chemical peels and laser resurfacing.
There are no data from the use of ingenol mebutate gel in pregnant women.
It reported clearance of the lesions in 5 of 8 patients who were randomized to received ingenol mebutate gel, 0.
The dermatologic agent, ingenol mebutate (Picato) is used topically for actinic keratosis and appears to be compatible in pregnancy, because blood levels of the drug and two of its metabolites were below the lower limit of quantification (0.
The independent clinical expert summary requested by the AWMSG advised that the short (two day) duration of treatment (which should give excellent compliance) and specific mode of action of ingenol mebutate make it suitable for use in primary care and may reduce the need for referral to secondary care.
Ingenol mebutate gel is a prescription only medicine to treat a type of skin damage, known as actinic or "solar" keratosis (AK), which is caused by long-term sun or UV exposure.
In early 2012, the FDA approved a topical gel containing ingenol mebutate (derived from the sap of the Euphorbia peplus plant) for the treatment of AKs.
The study showed that when Ingenol mebutate is applied to the skin it not only kills the cancerous cells but also recruits white blood cells that appear to reduce the risk of relapse by destroying any residual malignant cells that could allow the tumour to regrow.
candelabrum elicited irritant activity in the mouse ear, attributable to ingenol esters.
Ingenol mebutate gel for the treatment of actinic keratosis is an effective adjunct therapy to cryosurgery, and the absence of attendant serious local reactions can increase compliance, based on reported data from more than 100 patients.
An analysis of long-term clearance rates of actinic keratosis (AK) lesions after treatment with ingenol mebutate (Picato[sup.
Successful topical medications include 5-fluorouracil (5-FU), imiquimod 5% cream, diclofenac, and ingenol mebutate.