Calcitriol Pregnancy and Breastfeeding Warnings

Calcitriol is also known as: Calcijex, Rocaltrol

Calcitriol Pregnancy Warnings

Nonteratogenic effects noted in animals receiving calcitriol at doses approximately 6 times the maximum recommended for human use included increased maternal fatality, decreased fetal body weight, and a reduced number of newborns surviving up to 24 hours. A woman with hypoparathyroidism was successfully treated with calcitriol during pregnancy. Calcitriol was given throughout the pregnancy at a dose of 1.5 to 3 mcg per day without fetal adverse effects. Increases in dose were necessary during the last trimester to combat hypocalcemia, muscle cramps, and paresthesias. Mild hypercalcemia returning to normal by day 3 of life was reported in a neonate of a woman administered 17 mcg to 36 mcg of calcitriol daily (17 to 36 times the maximum recommended dose) during pregnancy. Earlier literature expressed concerns over the development of supravalvular aortic stenosis, craniofacial abnormalities, and dental abnormalities in infants and children with idiopathic hypercalcemia. Whether or not prenatal factors predisposed these children to the development of hypercalcemia is not known. Fifteen hypoparathyroid women receiving 50,000 to 250,000 Intl units of vitamin D2 experienced 27 uneventful births. No cardiovascular or craniofacial abnormalities were reported.

Calcitriol has been assigned to pregnancy category C by the FDA. Animal studies have shown calcitriol to be teratogenic, resulting in external and skeletal abnormalities, when used at doses 4 to 15 times the recommended human dose. There are no controlled data in human pregnancy. Calcitriol should be used during pregnancy only when benefit outweighs the risk.

Calcitriol Breastfeeding Warnings

There are no data on the excretion of calcitriol into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue calcitriol, taking into account the importance of the drug to the mother.

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