"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.
Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
The potential of calcipotriene to induce carcinogenesis in standard long-term animal studies (in the absence of ultra-violet radiation (UVR)) has not been evaluated. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply Dovonex to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients that use Dovonex.
Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.
Studies in rats at doses up to 54 |ig/kg/day (318 |lg/m /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
Teratogenic Effects: Pregnancy Category C
Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 |ig/kg/day (132 |lg/m /day). Rabbits administered 36 |ig/kg/day (396 |lg/m /day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 |ig/kg/day (318 |ig/m /day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 µg/m2/day) and rabbit (17.6 µg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 µg/m2/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Dovonex Cream (calcipotriene cream) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin. Because many drugs are excreted in human milk, caution should be exercised when Dovonex Cream (calcipotriene cream) is administered to a nursing woman.
Safety and effectiveness of Dovonex Cream (calcipotriene cream) in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.
Of the total number of patients in clinical studies of calcipotriene cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/22/2016
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