Picato

Last reviewed on RxList: 4/26/2021
Picato Side Effects Center

What Is Picato?

Picato (ingenol mebutate) gel is indicated for the topical treatment of actinic keratosis.

What Are Side Effects of Picato?

Common side effects of Picato include:

Picato gel may cause severe side effects if it comes in contact with eyes.

Dosage for Picato

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.

What Drugs, Substances, or Supplements Interact with Picato?

Picato may interact with other drugs. Tell your doctor all medications and supplements you use.

Picato During Pregnancy and Breastfeeding

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. It is unknown if Picato passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

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Picato Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed, dizzy; difficulty breathing, wheezing, chest tightness; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe skin redness, flaking, scaling, crusting, swelling;
  • blisters, pus, ulcers, or skin breakdown; or
  • (if this medicine gets in your eye) eye pain, redness, burning, swelling around the eye, drooping eyelid.

Ingenol topical may cause scars or changes in skin color where the medicine was applied.

Common side effects may include:

  • a skin reaction where you applied the medicine;
  • pain, itching, irritation, or infection where the medicine was applied;
  • swelling around the eyes;
  • headache; or
  • nose and throat irritation.

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.

Read the entire detailed patient monograph for Picato (Ingenol Mebutate)

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Picato Professional Information

SIDE EFFECTS

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

  • Ophthalmic Adverse Reaction [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Non-Melanoma Skin Cancer [see WARNINGS AND PRECAUTIONS]

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 0to4.Agradeof 0representednoreactionpresentinthetreatedarea,andagradeof 4indicated amarkedand 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%)
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%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible toreliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: chemical conjunctivitis, corneal burn

Immune system disorders: hypersensitivity, Stevens-Johnson syndrome

Infections: herpes zoster

Skin and subcutaneousdisorders: non-melanoma skin cancer, allergic contact dermatitis, application site pigmentation changes, application site scarring

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Picato (Ingenol Mebutate)

© Picato Patient Information is supplied by Cerner Multum, Inc. and Picato Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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