Pharmacology: Pharmacodynamics and Pharmacokinetics: Daivonex is a topical formulation of the vitamin D derivative, calcipotriol, which induces differentiation and suppresses proliferation of skin cell (keratinocytes). Daivonex thus normalises abnormal cell proliferation and differentiation in psoriatic skin.
Toxicology: Preclinical Safety Data: The effect on the calcium metabolism is approximately 100 times less than that of the hormonally active form of vitamin D3.
A dermal carcinogenicity study in mice revealed no special hazard to humans.
In a study where albino hairless mice were repeatedly exposed to both ultraviolet (UV) radiation and dermally administered calcipotriol for 40 weeks at dose levels corresponding to 9, 30 and 90μg/m2/day (equivalent to 0.25, 0.84, 2.5 times the maximum recommended daily dose for a 60 kg adult, respectively), a reduction in the time required for UV radiation to induce the formation of skin tumours was observed (statistically significant in males only), suggesting that calcipotriol may enhance the effect of UV radiation to induce skin tumours. The clinical relevance of this finding is unknown.
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