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Ingenol mebutate (United States and Canada: Not available): Drug information

Ingenol mebutate (United States and Canada: Not available): Drug information
(For additional information see "Ingenol mebutate (United States and Canada: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Picato [DSC]
Pharmacologic Category
  • Topical Skin Product
Dosing: Adult

Note: Picato gel has been discontinued in the United States for >1 year.

Actinic keratosis

Actinic keratosis: Topical:

Face or scalp: Apply 0.015% gel once daily to affected area for 3 consecutive days (Ref); patients not achieving clearance or that experience recurrence after achieving clearance ≥8 weeks after initial treatment may benefit from a second treatment course.

Trunk or extremities: Apply 0.05% gel once daily to affected area for 2 consecutive days (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages represent face/scalp and trunk/extremities incidences unless otherwise specified.

>10%:

Dermatologic: Crusted skin (74% to 80%), dermal ulcer (≤32%), desquamation (≤90%), erythema of skin (92% to 94%), exfoliation of skin (≤90%), localized vesiculation (face/scalp: ≤56%; trunk/extremities: ≤44%), pustules (face/scalp: ≤56%; trunk/extremities: ≤44%), skin erosion (≤32%), swelling of skin (face/scalp: 79%; trunk/extremities: 64%)

Local: Application site pain (face/scalp: 15%, trunk/extremities: 2%)

1% to 10%:

Dermatologic: Skin infection (face/scalp: 3%; at application site)

Local: Application site irritation (trunk/extremities: 4%), application site pruritus (8%)

Nervous system: Headache (face/scalp: 2%)

Ophthalmic: Periorbital edema (face/scalp: 3%)

Respiratory: Nasopharyngitis (trunk/extremities: 2%)

Frequency not defined: Ophthalmic: Conjunctivitis (including chemical-induced), eye pain, eyelid edema

Postmarketing:

Dermatologic: Allergic contact dermatitis, cicatrix of skin (application site), dyschromia (application site), Stevens-Johnson syndrome

Hematologic & oncologic: Skin carcinoma (literature suggests an incidence up to 9%, primarily squamous cell carcinoma of the skin) (Wang 2020)

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Infection: Herpes zoster infection

Ophthalmic: Conjunctivitis (chemical), corneal injury (burn), injury to eye region (FDA 2015)

Contraindications

Known hypersensitivity to ingenol mebutate or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Dermatologic reactions: Severe reactions including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ulceration may occur in the treated area. Do not apply ingenol mebutate gel until skin is healed from any prior drug or surgical treatment.

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, as well as allergic reactions leading to hospitalization, and allergic contact dermatitis, have been reported. If anaphylaxis or other clinically significant hypersensitivity reaction occurs, discontinue immediately and manage as medically appropriate.

• Ocular toxicity: Avoid treatment in the periocular area. Severe eye pain, chemical conjunctivitis, corneal burning, eyelid edema, eyelid ptosis, and periorbital edema can occur after exposure. Patients should wash their hands well immediately after applying and avoid transferring to the eye area. If accidental exposure occurs, patient should flush area with water and contact health care provider.

• Skin cancer, nonmelanoma: Cases of rapidly growing squamous cell carcinoma have been reported, usually occurring within a few weeks of treatment completion.

Product Availability

Picato gel has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, External:

Picato: 0.015% (3 ea [DSC]); 0.05% (2 ea [DSC]) [contains benzyl alcohol, isopropyl alcohol]

Generic Equivalent Available: US

No

Pricing: US

Gel (Picato External)

0.015% (per each): $443.35

0.05% (per each): $665.02

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Apply topically to one contiguous affected area of skin using one unit-dose tube; one unit-dose tube will cover ~5 cm x 5 cm (~25 cm2 or ~2 inch x 2 inch). Spread evenly then allow gel to dry for 15 minutes. Do not cover with bandages or occlusive dressings. Wash hands immediately after applying and avoid transferring gel to any other areas. Avoid washing or touching the treatment area or doing activities that cause sweating for ≥6 hours, and following this period of time, patients may wash the area with a mild soap. Not for oral, ophthalmic, or intravaginal use. Avoid application near or around the mouth and lips. Avoid transfer of gel to the periocular area. If accidental exposure occurs, flush area with water and contact health care provider.

Use: Labeled Indications

Actinic keratosis: Topical treatment of actinic keratosis

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic absorption is limited following topical administration; maternal use is not expected to result in fetal exposure.

Breastfeeding Considerations

It is not known if ingenol mebutate is present in breast milk.

Systemic absorption is limited following topical administration; maternal use is not expected to result in exposure via breastfeeding. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Avoid direct skin-to-skin contact with treated areas to prevent accidental transfer to a breastfeeding infant.

Monitoring Parameters

Monitor for signs/symptoms of hypersensitivity reactions; dermatologic toxicity; squamous cell carcinoma.

Mechanism of Action

Ingenol mebutate appears to induce primary necrosis of actinic keratosis with a subsequent neutrophil-mediated inflammatory response with antibody-dependent cytotoxicity of residual disease cells; killing residual disease cells may prevent future relapse (Ramsay 2011; Siller 2010).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Absorption through the skin is minimal (with proper use); expected systemic exposure is <0.1 ng/mL.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BR) Brazil: Picato;
  • (DK) Denmark: Picato;
  • (GB) United Kingdom: Picato;
  • (PL) Poland: Picato
  1. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012;366(11):1010-1019. doi:10.1056/NEJMoa1111170 [PubMed 22417254]
  2. Picato (ingenol mebutate) [prescribing information]. Madison, NJ: LEO Pharma Inc; March 2021.
  3. Ramsay JR, Suhrbier A, Aylward JH, et al. The sap from Euphorbia peplus is effective against human nonmelanoma skin cancers. Br J Dermatol. 2011;164(3):633-636. [PubMed 21375515]
  4. Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. Australas J Dermatol. 2010;51(2):99–105. [PubMed 20546215]
  5. UK Drug Safety update. Ingenol mebutate gel (Picato): suspension of the license due to risk of skin malignancy. Available at https://www.gov.uk/drug-safety-update/ingenol-mebutate-gel-picato-suspension-of-the-licence-due-to-risk-of-skin-malignancy. Published February 12, 2020.
  6. Wang Y, Lipner SR. Retrospective analysis of squamous cell carcinoma associated with ingenol mebutate reported to the US Food and Drug Administration. Dermatol Ther. 2020;33(6):e14114. doi:10.1111/dth.14114 [PubMed 32735056]
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