Contact with the eyes should be avoided. Eye disorders such as eye pain, eyelid oedema and periorbital oedema should be expected to occur after accidental eye exposure of Picato(R). Picato(R) must not be ingested. Administration of Picato(R) is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised. Picato(R) should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips. Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato(R). Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised. Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment. There are no data from the use of ingenol mebutate gel in pregnant women. Risks to humans receiving cutaneous treatment with ingenol mebutate gel are considered unlikely as Picato(R) is not absorbed systemically. As a precautionary measure, it is preferable to avoid the use of Picato(R) during pregnancy. Actinic keratosis is not a condition generally seen within the paediatric population. The safety and efficacy of Picato(R) for actinic keratosis in patients less than 18 years of age have not been established. Please see full prescribing information available at http://www.leo-pharma.com.
7. References
1. Garbe C. Ingenol mebutate gel 0.015% repeat use for multiple actinic keratoses on face and scalp: a 12 month pahse 3 clinical study. Presented at the World Congress on Cancers of the Skin, Edinburgh, Scotland. 4 September 2014
2. LP0041-22 Clinical Study Report EudraCT no. 2011-005018-13 01-Jul-2014 page 1,165
3. Berman B et al. Cutis. 2012; 89:241-50
4. Berman B et al. Journal of drugs in dermatology : JDD. 2014; 13:741-7
5. Lebwohl M et al. N Eng J Med. 2012; 366:1010-9
6. Goldberg L and Mamelak A. Journal of drugs in Dermatology. 2010; 9:1125-32
7. Frost C et al. The British journal of dermatology. 1994; 142:722-6
8. Sober A. Cancer. 1995; 75(2 Suppl):645-50
9. Ulrich M et al. Expert Opinion. 2010; 15:545 - 55
Global Media Contact
Polly Lutter
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polly.lutter@leo-pharma.com
Tel: +44-(0)20-7300-6137
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