Calcitriol Pregnancy and Breastfeeding Warnings
Brand names: Calcijex, Rocaltrol
Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.
Calcitriol Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-There is evidence that maternal calcitriol may enter the fetal circulation.
Animal studies showed external and skeletal abnormalities in some studies, but not others. High doses (about 6 times the maximum human dose) caused maternal mortality, decreased fetal weight, reduced newborn survival, and hypercalcemia in the offspring. Fetuses with supravalvular aortic stenosis have been seen with near fatal doses in animals. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Calcitriol Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-It is presumed that this drug passes into breast milk.
-If used during breastfeeding, monitor the serum calcium levels of the mother and the infant.
See also
References for pregnancy information
- Product Information. Rocaltrol (calcitriol). Roche Laboratories. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Calcijex (calcitriol). Abbott Pharmaceutical. 2016.
References for breastfeeding information
- Product Information. Rocaltrol (calcitriol). Roche Laboratories. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Calcijex (calcitriol). Abbott Pharmaceutical. 2016.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
