Ingenol Mebutate

Ingenol Mebutate Brand Name– Picato

What is Ingenol Mebutate

Ingenol mebutate (PEP005) is a topical gel indicated for the treatment of actinic keratosis (AK). It is derived from the sap of Euphorbia peplus, also known as petty spurge, radium weed, and milkweed.

In a pooled analysis of two trials of ingenol mebutate 0.015% for AK on the face and scalp (n = 547), 42.2% of patients treated with ingenol mebutate for 3 consecutive days had complete clearance of AK lesions (i.e., no visible AK lesions in treatment area) at day 57 compared to 3.7% of vehicle-treated patients (p < 0.001).

Partial clearance of AK (i.e., >= 75% reduction in number of AK lesions in treatment area) was reported in 63.9% of ingenol mebutate-treated patients compared to 7.4% of vehicle-treated patients (p < 0.001).

In pooled analysis of two trials of ingenol mebutate 0.05% for AK on the trunk and extremeties (n = 458), 34.1% of patients treated with ingenol mebutate for 2 consecutive days had complete clearance of AK lesions at day 57 compared to 4.7% of vehicle-treated patients (p < 0.001).

Partial clearance of AK was reported in 49.1% of ingenol mebutate-treated patients compared to 6.9% of vehicle-treated patients (p < 0.001).

Recurrence of AK (any identified AK lesion in the previously treated area) was reported at a rate of 54% on the face or scalp and at a rate of 50% on the trunk or extremeties during 12-months of follow-up of patients who had achieved complete clearance with ingenol mebutate in the previous study periods.

 Ingenol mebutate was approved by the FDA in January 2012.

Indications

• actinic keratosis

For the treatment of actinic keratosis (AK)

Side Effects

1. anaphylactoid reactions
2. blepharedema
3. conjunctivitis
4. contact dermatitis
5. edema
6. erythema
7. erythema
8. headache
9. infection
10. ocular pain
11. pharyngitis
12. pruritus
13. ptosis
14. skin discoloration
15. skin erosion
16. skin erosion
17. skin irritation
18. skin ulcer
19. skin ulcer
20. vesicular rash
21. vesicular rash

Monitoring Parameters

• laboratory monitoring not necessary

Contraindications

• accidental exposure
• breast-feeding
• children
• herpes infection
• infants
• neonates
• ocular exposure
• pregnancy
• serious rash

Interactions

There are no drug interactions associated with Ingenol Mebutate products.