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 ?
Patients were randomized to either 5% fluorouracil cream, 5% imiquimod cream, methyl aminolevulinate photodynamic therapy (MAL-PDT), or 0.015% ingenol mebutate gel.
Ingenol mebutate is a US Food and Drug Administration-approved topical treatment for actinic keratosis.
A factory was then set-up on the Gold Coast to manufacture the key ingredient ingenol mebutate or PEP005.
Concurrently, skin segments (25 [cm.sup.2] each) with HC induced "squamous dysplasia" [5] were treated topically with the combination of cryosurgery sessions (liquid N2, open spray, 2 cycles of 10 sec each, applied in quarters of the segment) and, starting on the same day, application of ingenol mebutate gel as per manufacturer's recommendations.
A recent multicentre phase 2 trial reported complete clearance in 35.6% of individuals with AK to the face and chest with a once-daily for 3 days application regime of ingenol disoxate gel [12].
Healthcare company Perrigo Company plc (NYSE; TASE: PRGO) reported on Thursday the receipt of tentative approval from the US Food and Drug Administration (FDA) for the generic version of Picato Gel (ingenol mebutate) 0.05%.
Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Tuesday the receipt of tentative approval from the US Food and Drug Administration (FDA) for the generic version of Picato Gel (ingenol mebutate) 0.015% indicated for the topical treatment of actinic keratosis.
Recently, a new protein kinase C (PKC) activator, Ingenol B, has been used to reactivate HIV latency in vitro.
TABLE 1: Plant-derived natural products approved for therapeutic use Trade name/Year Generic name Plant species of introduction Indication Artemisinin Artemisia annua Artemisinin-1987 Malaria treatment Capsaicin Capsicum annuum Qutenza-2010 Postherpetic neuralgia Galantamine Galanthus Razadyne-2001 Dementia caucasicus associated with ALZ Ingenol Euphorbia peplus Picato-2012 Actinic mebutate keratosis Paclitaxel Taxus brevifolia Taxol-1993 Cancer Abraxane-2005 chemotherapy Nanoxel-2007 Masoprocol Larrea tridentata Actinex-1992 Cancer chemotherapy Source: Atanasov et al.
Just recently, he has developed a 14-step recipe for ingenol and reduced the steps required to make phorbol from 40 or more to just 19.
Treatment options for actinic keratoses include cryotherapy or field therapy with 5-fluorouracil, imiquimod, ingenol mebutate, or photodynamic therapy.
Options include 5-FU (5-fluorouracil), imiquimod, ingenol mebutate, and photodynamic therapy as well as chemical peels and laser resurfacing.