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(in-je-nol) ,


(trade name)


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


Topical treatment of actinic keratoses.


Acts as an inducer of cell death.

Therapeutic effects

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


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)

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


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


  • 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


Drug-Drug interaction

None noted


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.


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)


  • 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 ?
New data from the international FIELD Study Repeat presented today at the 15th World Congress of Cancers of the Skin (WCCS) in Edinburgh, Scotland, demonstrate initial treatment with Picato (ingenol mebutate gel) 0.
The FIELD Study Repeat followed patients over a one-year-period, confirming both the short and in particular the long-term benefits when treating once or twice of Picato with an overall 50% complete clearance of all AK lesions after one year.
The new data from the FIELD Study Repeat validate Picato as a well-tolerated field-directed therapy, suitable for the long-term treatment of actinic keratoses, showing an overall high complete clearance rate after one year.
The gel was approved by the Food and Drug Administration for use in the United States in early 2012 under the name Picato (LEO Pharmaceuticals).
Picato comes in two strengths, one for the face and scalp and the other for trunk and limbs.
In clinical trials, 60% to 68% of patients with AKs on the face and scalp and 44% to 55% with AKs on the trunk and extremities saw a 75% or greater reduction in existing lesions with Picato.
There was a small Australian clinical trial using Picato to treat superficial basal cell carcinomas (BCC).
Picato gel is applied over a 25cm[2] treatment area for two consecutive days when treating actinic keratoses on the trunk and extremities (500 mcg/g) and over three consecutive days for the face and scalp (150mcg/g).
The mechanism of action (MoA) for Picato gel is not fully understood.
The European Commission granted marketing authorisation for Picato in Europe on 15 November 2012.
The Picato Experience Program survey, sponsored by LEO Pharma Inc.
After successfully gaining FDA approval in April for Picato, a novel treatment for solar keratoses, LEO Pharma has initiated a global search for new partners within dermatology.