The Protopic PI says that patients should “minimize or avoid natural or artificial sunlight exposure.” Are there problems associated with Protopic patients who are exposed to sunlight?
Tacrolimus is not photoactivated and thus should not have any different effects if exposed to sunlight. As the PI states, there was a shorter “time to skin tumor formation” noted in a photocarcinogenicity study using an animal model designed to produce tumors in all dose groups and animals. In this study, the same tumor amplification factor was noted in the mice receiving vehicle and those receiving commercially available concentrations of Protopic. There was no increased evidence of skin cancer during clinical trials of Protopic.
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