Picato

PICATO- ingenol mebutate gel
LEO Pharma Inc.

1 INDICATIONS AND USAGE

Picato ® gel is indicated for the topical treatment of actinic keratosis.

2 DOSAGE AND ADMINISTRATION

For the treatment of actinic keratosis on the face or scalp Picato gel, 0.015% should be applied to the affected area once daily for 3 consecutive days.

For the treatment of actinic keratosis on the trunk or extremities Picato gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.

Picato gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm × 5 cm) using one unit dose tube. After spreading evenly over the treatment area, the gel should be allowed to dry for 15 minutes. Patients should wash their hands immediately after applying Picato gel and take care not to transfer the applied drug to other areas, including the eye. Patients should avoid washing and touching the treated area for a period of 6 hours after application of Picato gel. Following this time, patients may wash the area with a mild soap.

Avoid transfer of Picato gel to periocular area [see Warnings and Precautions (5.1)].

Avoid application near and around the mouth and lips.

For topical use only; not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Picato gel contains 0.015% or 0.05% of ingenol mebutate in a clear colorless gel base.

4 CONTRAINDICATIONS

Picato gel is contraindicated in patients with known hypersensitivity to ingenol mebutate or any component of the formulation. Anaphylaxis, as well as allergic reactions leading to hospitalization have been reported in postmarketing use with Picato gel [see Warnings and Precautions (5.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Ophthalmic Adverse Reactions

Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure [see Adverse Reactions (6)].

To avoid transfer of the drug into the eyes and to the periocular area during and after application, patients should wash hands well after applying Picato gel. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible.

5.2 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and allergic contact dermatitis, have been reported postmarketing. If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato gel immediately and institute appropriate medical therapy.

5.3 Local Skin Reactions

Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, can occur after topical application of Picato gel [see Adverse Reactions (6 )]. Administration of Picato gel is not recommended until the skin is healed from any previous drug or surgical treatment.

6 ADVERSE REACTIONS

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

  • Ophthalmic Adverse Reaction [see Warnings and Precautions (5.1)]
  • Hypersensitivity Reactions [see Warnings and Precautions (5.2)]

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%)

a Mild (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%)

a Mild (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 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.

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