Adult Dosing

Actinic keratosis

• Apply 0.015% gel to the affected area (face and scalp) qd x 3 days
• Apply 0.05% gel to the affected area (trunk and extremities) qd x 2 days

• Intended for topical use only; not for oral, ophthalmic, or intravaginal use
• Limit therapy area to one contiguous skin area of approximately 25 sq cm using one unit dose tube
• Spread gel evenly over the affected area and allow the gel to dry for 15 minutes
• Wash hands immediately after application and take care not to transfer the applied drug to other areas, including the eye
• Avoid washing and touching the treated area for 6 hours after application; following this time, patients may wash the area with a mild soap

Pediatric Dosing

• Safety and effectiveness have not been established in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Topical treatment of actinic keratosis

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Eye disorders such as severe eye pain, eyelid edema, eyelid ptosis, and periorbital edema may occur following eye exposure. Avoid transfer of the drug to the periocular area during and after application. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible
• Erythema, crusting, swelling, vesiculation/postulation, and erosion/ulceration may occur in the treated area after topical application of the gel
• Ingenol mebutate is not recommended until the skin is healed from any previous drug or surgical treatment

Supplemental Patient Information

• Advise patients to avoid contact with the eyes
• Inform patients that therapy may lead to local skin reactions
• Instruct patients to avoid inadvertent transfer of the gel to other areas or to another person
• Inform patients to spread gel evenly over the affected area and allow the treated area to dry for 15 minutes
• Advise patients to wash hands immediately after application and take care not to transfer the applied drug to other areas, including the eye
• Instruct patients to avoid washing and touching the treated area or participating in tasks that cause excessive sweating for 6 hours after application; following this time, patients may wash the area with a mild soap
• Instruct patients to keep out of the reach of children

Pregnancy Category:C

Breastfeeding: Safety unknown.

• CNS: Headache
• EENT: Nasopharyngitis, eyelid edema, eye pain, conjunctivitis
• DERM: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration, periorbital edema
• LOCAL: Application site pain, pruritus, infection, irritation

• Inducer of cell death; mechanism of action is unknown
• Systemic exposure (<0.1 ng/mL) is negligible; metabolites were below the lower limit of quantification
• Extensively metabolized in human hepatocytes
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Picato

US Availability

Picato (ingenol mebutate)

• GEL: 0.05%, 0.015%

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Antineoplastics, Topical

Cell Death Inducers