July 28, 2016
Recommended Topic Related To:

Picato

"Rebound growth of infantile hemangiomas (IHs) may occur in up to a quarter of patients treated with oral propranolol (OP) therapy, and early discontinuation of therapy may double this risk, according to a new retrospective study. These findings a"...

A A A

Picato




Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

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® gel 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.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Picato (ingenol mebutate) gel, 0.015% and 0.05%: hypersensitivity, allergic contact dermatitis, herpes zoster, chemical conjunctivitis, and corneal burn.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/15/2015

Side Effects
Interactions

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.


Women's Health

Find out what women really need.