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Picato (Ingenol Mebutate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

6.1 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)

Face and Scalp

(n=545)

Picato® gel, 0.015% once daily for 3 days

Skin reactions

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)

Trunk and Extremities

(n=457)

Picato® gel, 0.05% once daily for 2 days

Skin reactions

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)

Face/Scalp

Adverse Reactions

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)

Trunk/Extremities

Adverse Reactions

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.



REPORTS OF SUSPECTED PICATO SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Picato. The information is not vetted and should not be considered as verified clinical evidence.

Possible Picato side effects / adverse reactions in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 73 year old male weighing 83.9 kg (184.6 pounds)

Reactions: Urticaria, Drug Prescribing Error, Discomfort

Adverse event resulted in: life threatening event

Suspect drug(s):
Picato



Possible Picato side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 42 year old female

Reactions: Chest Pain, Skin Disorder, Erythema, Blister

Adverse event resulted in: disablity

Suspect drug(s):
Picato



Possible Picato side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: 42 year old female

Reactions: Skin Exfoliation, Pain, Pyrexia, Rash, Erythema, Blister

Suspect drug(s):
Picato



See index of all Picato side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-21

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