Calcitrene

INDICATIONS AND USAGE 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.

DOSAGE AND ADMINISTRATION Apply a thin layer of Calcitrene ® (calcipotriene) ointment, 0.005% once or twice daily and rub in gently and completely.

CONTRAINDICATIONS 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.

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.

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.