Risk Factor: CM*
Fetal Risk Summary
Calcitriol is one of three physiologically active forms of vitamin D (see Vitamin D). Calcitriol is teratogenic in rabbits dosed with 0.08 and 0.3 mg/kg (about 2 and 6 times the maximum recommended human dose based on mg/m2 [MRHD]) (1). Defects observed included external and skeletal malformations. The higher dose (0.3 mg/kg/day) given on gestation days 7 to 18 also increased maternal mortality, decreased mean fetal body weight, and reduced the number of newborn surviving to 24 hours. No teratogenic effects were observed in rats treated with doses up to 0.45 mg/kg (about 5 times the MRHD) (1). However, hypercalcemia was measured in the offspring of rats given 0.08 and 0.3 g/kg/day (about 1 and 3 times the MRHD) (1).
The manufacturer cites a case of mild hypercalcemia during the first 2 days of life in an infant who was exposed to a maternal dose of 17 to 36 mg/day (approximately 17 to 36 times the maximum recommended dose) during pregnancy (1). The hypercalcemia resolved by the third day.
[*Risk Factor D if used in doses above the recommended daily allowance.]
Breast Feeding Summary
See Vitamin D.
- Product information. Rocaltrol. Roche Laboratories, 2000.