Calcipotriene

Calcitrene ® (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.

Calcitrene ® (calcipotriene) ointment, 0.005%, 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 should not be used on the face.

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

Pregnancy 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. 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/m 2 /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, Calcitrene ® (calcipotriene) ointment, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.