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Use in Pregnancy: There are limited amount of data from the use of alfacalcidol in pregnant women. Studies in animals have shown reproductive toxicity.
One-Alpha should not be used in pregnancy unless clearly necessary as hypercalcaemia during pregnancy may produce congenital disorder in the offspring. Caution should be exercised in women of childbearing potential.
Use in Lactation: Alfacalcidol is excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from One-Alpha therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Breastfed infants of alfacalcidol-using mothers should be monitored closely for hypercalcaemia.
