Etelcalcetide Pregnancy and Breastfeeding Warnings

Brand names: Parsabiv

Medically reviewed by Drugs.com. Last updated on Oct 21, 2024.

Etelcalcetide Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no available data in pregnant women; in animal studies, there was reduced fetal growth associated with maternal toxicities of hypocalcemia, tremoring, and reductions in body weight and food consumption.

Administration of this drug at 1.8 times the human exposure to pregnant rats during organogenesis through delivery and weaning revealed a slight increase in perinatal pup mortality, delay in parturition, and transient effects on pup growth. No effect on sexual maturation, neurobehavioral, or reproductive function were seen in the rat offspring. In embryofetal studies in rats and rabbits administered 2.7 and 7 times, respectively, the estimated human dose during organogenesis revealed reduced fetal growth. 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

Etelcalcetide Breastfeeding Warnings

Not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Because of the potential for hypocalcemia in the breastfed infant, this drug is not recommended while breastfeeding.

This drug was found in the milk of lactating rats at levels similar to plasma.

See references

Further information

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