Note: Picato gel has been discontinued in the United States for >1 year.
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).
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
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)
Known hypersensitivity to ingenol mebutate or any component of the formulation.
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.
Picato gel has been discontinued in the United States for >1 year.
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]
No
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.
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.
Actinic keratosis: Topical treatment of actinic keratosis
None known.
There are no known significant interactions.
Systemic absorption is limited following topical administration; maternal use is not expected to result in fetal exposure.
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.
Monitor for signs/symptoms of hypersensitivity reactions; dermatologic toxicity; squamous cell carcinoma.
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).
Absorption: Absorption through the skin is minimal (with proper use); expected systemic exposure is <0.1 ng/mL.
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