November 30, 2015
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Included as part of the PRECAUTIONS section.


Ophthalmic Adverse Reactions

Avoid treatment in the periocular area. Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure [see ADVERSE REACTIONS].

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.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and allergic contact dermatitis, have been reported post-marketing [see ADVERSE REACTIONS]. If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato® gel immediately and instituteappropriate medical therapy.

Local Skin Reactions

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

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use)

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions can occur with Picato® gel. Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur [see WARNINGS AND PRECAUTIONS].

Ophthalmic Adverse Reactions

Inform patients that severe eye injury can occur with Picato® gel. Advise patients that Picato® gel is not for ophthalmic use. Advise patients to avoid application around the eyes. If severe eye pain or other symptoms of accidental exposure occur, advise patients to flush eyes with water and seek medical care [see WARNINGS AND PRECAUTIONS].

Local Skin Reactions

Inform patients that treatment with Picato® gel may lead to local skin reactions [see WARNINGS AND PRECAUTIONS].

Important Administration Instructions

Advise patients that Picato® gel is for external use only. Advise patients to avoid application near and around the eyes, mouth and lips.

Patients should avoid inadvertent transfer of Picato® gel to other areas, or to another person.

Instruct patients to:

  • allow the treated area to dry for 15 minutes after application.
  • avoid washing and touching the treated area, or participating in activities that cause excessive sweating, for 6 hours after treatment. Following this time, patients may wash the area with a mild soap and water.
  • keep out of the reach of children.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Picato® gel or ingenol mebutate. The effects of ingenol mebutate on fertility have not been evaluated.

Ingenol mebutate was negative in the Ames test, in vitro mouse lymphoma assay, and in vivo rat micronucleus test, but positive in the Syrian hamster embryo (SHE) cell transformation assay.

Use In Specific Populations


Pregnancy Category C

There are no adequate and well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemic embryofetal development studies were conducted with ingenol mebutate in rats and rabbits. Intravenous doses of 1.5, 3, and 5 .g/kg/day (9, 18, and 30 μg/m²/day) ingenol mebutate were administered during the period of organogenesis (gestational days 6 – 16) to pregnant female rats. No treatment related effects on embryofetal toxicity or teratogenicity were noted at doses up to 5 .g/kg/day (30 μg/m²/day). Intravenous doses of 1, 2, and 4 .g/kg/day (12, 24, and 48 μg/m²/day) ingenol mebutate were administered during the period of organogenesis (gestational days 6 – 18) to pregnant female rabbits. An increase in embryo-fetal mortality was noted at 4 .g/kg/day (48 μg/m²/day). An increased incidence of fetal visceral and skeletal variations was noted in all three ingenol mebutate dose groups. The clinical relevance of these findings is unclear since systemic exposure of ingenol mebutate was not detected in subjects with actinic keratosis treated with Picato® gel, 0.05% applied to a 100 cm² treatment area [see CLINICAL PHARMACOLOGY].

Pediatric Use

Actinic keratosis is not a condition generally seen within the pediatric population.

The safety and effectiveness of Picato® gel for actinic keratosis in patients less than 18 years of age have not been established.

Geriatric Use

Of the 1165 subjects treated with Picato® gel in the clinical trials, 56% were 65 years and older and, 21% were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

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

Last reviewed on RxList: 10/15/2015


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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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