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Picato
Picato Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Picato (ingenol mebutate) gel is indicated for the topical treatment of actinic keratosis. The most common adverse reactions are local skin reactions, application site pain, application site pruritus, application site irritation, application site infection, flaking, scaling, crusting, nasopharyngitis and headache. Picato gel may cause severe side effects if it comes in contact with eyes.
For the treatment of actinic keratosis on the face and scalp Picato gel, 0.015% should be applied to the affected area once daily for three consecutive days. For the treatment of actinic keratosis on the trunk and extremities Picato gel, 0.05% should be applied to the affected area once daily for two consecutive days.
It is not known if Picato gel is harmful to unborn babies. Picato gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Our Picato Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Picato FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to Picato® gel in 499 subjects with actinic keratosis, including 274 subjects exposed to Picato® gel field treatment (skin area of 25 cm² in the face or scalp regions) at a concentration of 0.015% once daily for 3 consecutive days, and 225 subjects exposed to Picato® gel field treatment (skin area of 25 cm² in the trunk or extremities regions) at a concentration of 0.05% once daily for 2 consecutive days.
Local skin reactions, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration were assessed within the selected treatment area and graded by the investigator on a scale of 0 to 4. A grade of 0 represented no reaction present in the treated area, and a grade of 4 indicated a marked and severe skin reaction that extended beyond the treated area.
Table 1 : Investigator Assessment of Maximal Local Skin
Reactions in the Treatment Area during the 57 Days Post Treatment Period
(face/scalp trials)
| Skin reactions | Face and Scalp (n=545) | Picato® gel, 0.015% once daily for 3 days | ||
| Any Gradea > Baseline | Grade 4 | |||
| Picato® gel (n=274) |
Vehicle (n=271) |
Picato® gel (n=274) |
Vehicle (n=271) |
|
| Erythema | 258 (94%) | 69 (25%) | 66 (24%) | 0 (0%) |
| Flaking/Scaling | 233 (85%) | 67 (25%) | 25 (9%) | 0 (0%) |
| Crusting | 220 (80%) | 46 (17%) | 16 (6%) | 0 (0%) |
| Swelling | 217 (79%) | 11 (4%) | 14 (5%) | 0 (0%) |
| Vesiculation/Pustulation | 154 (56%) | 1 (0%) | 15 (5%) | 0 (0%) |
| Erosion/Ulceration | 87 (32%) | 3 (1%) | 1 (0%) | 0 (0%) |
| aMild (grade 1), Moderate (grade 2-3) or Severe (grade 4). | ||||
Table 2 : Investigator
Assessment of Maximal Local Skin Reactions in the Treatment Area during the 57
Days Post Treatment Period (trunk/extremities trials)
| Skin reactions | Trunk and Extremities (n=457) | Picato® gel, 0.05% once daily for 2 days | ||
| Any Gradea > Baseline | Grade 4 | |||
| Picato® gel (n=225) |
Vehicle (n=232) |
Picato® gel (n=225) |
Vehicle (n=232) |
|
| Erythema | 207 (92%) | 43 (19%) | 34 (15%) | 0 (0%) |
| Flaking/Scaling | 203 (90%) | 44 (19%) | 18 (8%) | 0 (0%) |
| Crusting | 167 (74%) | 23 (10%) | 8 (4%) | 0 (0%) |
| Swelling | 143 (64%) | 13 (6%) | 7 (3%) | 0 (0%) |
| Vesiculation/Pustulation | 98 (44%) | 2 (1%) | 3 (1%) | 0 (0%) |
| Erosion/Ulceration | 58 (26%) | 6 (3%) | 2 (1%) | 0 (0%) |
| aMild (grade 1), Moderate (grade 2-3) or Severe (grade 4). | ||||
Local skin reactions typically occurred within 1 day of treatment initiation, peaked in intensity up to 1 week following completion of treatment, and resolved within 2 weeks for areas treated on the face and scalp, and within 4 weeks for areas treated on the trunk and extremities.
Adverse reactions that occurred in ≥ 2% of subjects treated with Picato® gel and at a higher frequency than the vehicle are presented in Table 3 and Table 4.
Table 3 : Adverse reactions
occurring in ≥ 2% of subjects treated with Picato® gel and at higher frequency than vehicle (face/scalp
trials)
| Adverse Reactions | Face/Scalp | |
| Picato® gel, 0.015% (N=274) |
Vehicle (N=271) |
|
| Application Site Pain | 42 (15%) | 1 (0%) |
| Application Site Pruritus | 22 (8%) | 3 (1%) |
| Application Site Infection | 7 (3%) | 0 (0%) |
| Periorbital Edema | 7 (3%) | 0 (0%) |
| Headache | 6 (2%) | 3 (1%) |
Table 4 : Adverse reactions
occurring in ≥ 2% of subjects treated with Picato® gel and at higher frequency than vehicle (trunk/extremities
trials)
| Adverse Reactions | Trunk/Extremities | |
| Picato® gel, 0.05% (N=225) |
Vehicle (N=232) |
|
| Application Site Pruritus | 18 (8%) | 0 (0%) |
| Application Site Irritation | 8 (4%) | 1 (0%) |
| Nasopharyngitis | 4 (2%) | 2 (1%) |
| Application Site Pain | 5 (2%) | 0 (0%) |
Less common adverse reactions in subjects treated with Picato® included: eyelid edema, eye pain, conjunctivitis.
A total of 108 subjects treated with Picato® gel on the face/scalp and 38 subjects treated on the trunk/extremities were followed for 12 months. Results from these studies did not change the safety profile of Picato® gel.
Read the entire FDA prescribing information for Picato (Ingenol Mebutate) »
Additional Picato Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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