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Picato

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Picato

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Eye Exposure

Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure [see ADVERSE REACTIONS]. Patients should wash hands well after applying Picato® gel, and avoid transfer of the drug to the periocular area during and after application [see PATIENT INFORMATION]. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible [see ADVERSE REACTIONS].

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)”

Picato® gel should be used as directed by a physician.

Picato® gel is for external use only. Advise patients to avoid contact with the eyes. Inform patients that treatment with Picato® gel may lead to local skin reactions [see WARNINGS AND PRECAUTIONS].

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.
  • 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

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 μg/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 μg/kg/day (30 μg/m²/day). Intravenous doses of 1, 2, and 4 μg/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 μg/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.

Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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