ingenol

(redirected from Picato)

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 ?
M2 EQUITYBITES-November 3, 2017-Perrigo wins US FDA's tentative approval for first-to-file generic Picato Gel 0.
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.
M2 PHARMA-October 25, 2017-Perrigo wins US FDA's tentative approval for first-to-file generic Picato Gel .
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.
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 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.
LEO Pharma has announced that the Food and Drug Administration has approved Picato (ingenol mebutate) gel (0.
M2 EQUITYBITES-October 25, 2017-Perrigo wins US FDA's tentative approval for first-to-file generic Picato Gel .
The drawback is the cost, but, if you compare this with Picato [ingenol mebutate] and Aldara [imiquimod], you must calculate that they are approved for 25 [cm.
M2 PHARMA-January 26, 2012-LEO Pharma gets FDA nod for Picato (ingenol mebutate) gel for actinic keratoses(C)2012 M2 COMMUNICATIONS