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Calcitriol Pregnancy and Breastfeeding Warnings

Calcitriol is also known as: Calcijex, Rocaltrol

Calcitriol Pregnancy Warnings

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.

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.

See references

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 references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Rocaltrol (calcitriol)." Roche Laboratories, Nutley, NJ.
  4. "Product Information. Calcijex (calcitriol)." Abbott Pharmaceutical, Abbott Park, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Rocaltrol (calcitriol)." Roche Laboratories, Nutley, NJ.
  3. "Product Information. Calcijex (calcitriol)." Abbott Pharmaceutical, Abbott Park, IL.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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