Dovonex

Calcipotriene Ointment, 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.

Calcipotriene Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene Ointment should not be used on the face.

Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Ointment.

Pregnancy Teratogenic Effects Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 μg/kg/day (132 μg/m 2 /day); a dosage of 36 μg/kg/day (396 μg/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 μg/kg/day (318 μg/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 μg/m2/day) and rabbit (17.6 μg/m 2 /day) studies are approximately equal to the expected human systemic exposure level (18.5 μg/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.