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Doxercalciferol Pregnancy and Breastfeeding Warnings

Doxercalciferol is also known as: Hectorol

Medically reviewed by Drugs.com. Last updated on Dec 14, 2018.

Doxercalciferol Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-The limited data on use in pregnant women are insufficient to identify a risk for major birth defects, miscarriage, or other adverse effects with this drug.
-The risk of maternal hypertension, preeclampsia, miscarriage, premature birth polyhydramnios, stillbirth, and low birth weight are increased in patients with chronic kidney disease.

Animal studies showed no adverse effects on fetal development when given during organogenesis at doses up to 20 mcg/kg/day [about 25 times the Maximum Human Recommended Dose (MRHD)] in rats (0.1 mcg/kg/day or less than the MRHD in rabbits). There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Doxercalciferol Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Monitor infants exposed to this drug for hypercalcemia symptoms including seizures, vomiting, constipation, and weight loss.
-Consider monitoring the infant's serum calcium.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Hectorol (doxercalciferol)." Genzyme Corporation, Cambridge, MA.
  2. "Product Information. Hectorol (doxercalciferol)" Genzyme Corporation, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Hectorol (doxercalciferol)" Genzyme Corporation, Cambridge, MA.
  2. "Product Information. Hectorol (doxercalciferol)." Genzyme Corporation, Cambridge, MA.

Further information

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

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