Published: 10 December 2015

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Ingenol Mebutate (Picato) Correct Use and Adverse Reactions

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Prescriber Update 36(4): 49
December 2015

Picato gel contains ingenol mebutate. It is indicated for the topical treatment of solar keratoses in adults¹. Each tube is a single dose and should be used over an area of up to 25 cm² ¹. The gel should be spread evenly over the entire treatment area¹.

Two different strengths are available for use in different areas of the body. Picato gel 0.05% can be applied on the trunk and extremities in adults. Picato gel 0.015% can be applied on the face and scalp in adults. If the lesion is near the eyes, nostrils or mouth a smaller treatment area may be used ².

Administration of Picato gel is not recommended until the skin has healed from any previous treatments¹. Patients should be instructed to wash their hands immediately after applying the gel¹. Touching and washing the treatment area should be avoided for six hours after the application of Picato gel¹.

Most patients experience one or more local skin response(s) following application of this medicine¹. These show that the treatment is working ². Application site reactions frequently reported include erythema, crusting, swelling, exfoliation, and scabbing. Internationally, there have been reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel³.

Local skin responses typically resolve within two weeks of treatment initiation on the face or scalp and within four weeks for treatment on the trunk and extremitie s¹.

Healthcare professionals are encouraged to report all suspected adverse reactions to Picato gel, and all other medicines, to the Centre for Adverse Reactions Monitoring (CARM). Reports may be submitted on paper or electronically (https://nzphvc.otago.ac.nz).

References

1. LEO Pharma. 2014. Picato Gel Data Sheet 19 February 2014. URL:www.medsafe.govt.nz/profs/datasheet/p/picatogel.pdf (accessed 5 October 2015).
2. LEO Pharma. 2013. Picato Gel Consumer Medicine Information April 2013. URL:www.medsafe.govt.nz/consumers/cmi/p/picatogel005.pdf (accessed 5 October 2015) and www.medsafe.govt.nz/consumers/cmi/p/picatogel0015.pdf (accessed 27 October 2015).
3. Food and Drug Administration. 2015. FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for skin condition; requires label changes. FDA Drug Safety Communication 21 August 2015. URL: www.fda.gov/Drugs/DrugSafety/ucm459142.htm (accessed 27 October 2015).