Picato (Ingenol Mebutate) Gel 0.05%

Topical Skin Product

“Special Alerts

Picato Safety Alert July 2020:  Health Canada has conducted a safety review and found that there may be a link between Picato (ingenol mebutate) and an increased risk of skin cancer. Health Canada is seeking additional information from the manufacturer to determine whether the benefits of Picato as a treatment option for actinic keratosis continue to outweigh the risks. Health care providers should tell patients taking Picato to watch for the development of skin lesions where the medication is applied and to seek medical assistance if they occur.

*Further information may be found at https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73461a-eng.php.”

CSA NA – FDA Approved – REMS (N) – Can Ship

Picato/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.

Officially indicated for the treatment of actinic keratosis.

Do not use if the patient experiences a hypersensitivity reaction which can include anaphylaxis

Dermatological reactions including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ulceration may occur in the treated area

Never applied near the eye due to the risk of ocular toxicity

Actinic Keratosis

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

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

How to Apply Ingenol Mebutate, Picato:  Wash your hands prior to and after applying Picato/Ingenol Mebutate gel topically to one contiguous affected area of skin.  Spread evenly then allow gel to dry for 15 minutes.  Do not cover with bandages or occlusive dressings.  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.  To be used externally only and do not apply near your mouth, eye, and mucous membranes.  If accidental exposure occurs near or inside the eye, flush area with water and contact health care provider due to a risk of ocular toxicity.

The most common adverse reactions are primarily dermatologic unless otherwise specified:

>10%

Dermatologic: Erythema of skin (92% to 94%), desquamation (≤90%), exfoliation of skin (≤90%), crusted skin (74% to 80%), swelling of skin (face/scalp: 79%; trunk/extremities: 64%), localized vesiculation (face/scalp: ≤56%; trunk/extremities: ≤44%), pustules (face/scalp: ≤56%; trunk/extremities: ≤44%), dermal ulcer (≤32%), skin erosion (≤32%), application site pain (face/scalp: 15%, trunk/extremities: 2%)