CONTRAINDICATIONS
Calcipotriene cream 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 cream
should not be used on the face.
PRECAUTIONS
General: Use of calcipotriene cream may cause tansient irritation of both lesions and
surrounding uninvolved skin. If irritation develops, calcipotriene cream should be
discontinued.
Reversible elevation of serum calcium has occurred with use of calcipotriene cream. If
elevation in serum calcium outside the normal range should occur, discontinue treatment
until normal calcium levels are restored.
Information for the Patient: Patients using calcipotriene cream should receive the
following information and instructions:
1. This medication is to be used as directed by the physician. It is for external use
only. Avoid contact with the face or eyes. As with any topical medication, patients
should wash hands after application.
2. This medication should not be used for any disorder other than that for which it
was prescribed.
3. Patients should report to their physician any signs of adverse reactions.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Animal studies have not
been conducted to evaluate the carcinogenic potential of calcipotriene. Studies in rats at
doses up to 54 m/kg/day (318 m/m2/day) of calcipotriene indicated no impairment of
fertility or general reproductive performance.
Calcipotriene did not elicit any mutagenic effects in the Ames mutagenicity assay, the
mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test or
the mouse micronucleus test.
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. Increased rabbit maternal and fetal toxicity was noted
at 12 mcg/kg/day (132 mcg/m2/day). Rabbits administered 36 mcg/kg/day (396
mcg/m2/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 mcg/kg/day (318 mcg/m2/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 mcg/m2/day) and rabbit
(17.6 mcg/m2/day) studies are approximately equal to the expected human systemic
exposure level (18.5mcg/m2/day) from dermal application. There are no adequate and
well-controlled studies in pregnant women. Therefore, calcipotriene cream should be
used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: 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 calcipotriene cream is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of calcipotriene cream in pediatric patients have
not been established. Because of a higher ratio of skin surface area to body mass,
children are at greater risk than adults of systemic adverse effects when they are treated
with topical medication.