Calcipotriene

Clinical summary

Indications and usage INDICATIONS AND USAGE Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. Dosage and administration DOSAGE AND ADMINISTRATION Apply a thin layer of calcipotriene ointment USP, 0.005% once or twice daily and rub in gently and completely. Warnings and cautions WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene. Pregnancy Pregnancy Teratogenic Effects Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40 to 60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage 12 mcg/kg/day (132 mcg/m 2 /day); a dosage of 36 mcg/kg/day (396 mcg/m 2 /day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (318 mcg/m 2 /day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels in the rat (43.2 mcg/m 2 /day) and rabbit (17.6 mcg/m 2 /day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m 2 /day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, calcipotriene ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.