Parsabiv

Parsabiv Use In Pregnancy & Lactation

etelcalcetide

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data from the use of etelcalcetide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.
Breast-feeding: It is unknown whether etelcalcetide is present in human milk. Available data in rats have shown that etelcalcetide is excreted in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Parsabiv therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No data are available on the effect of etelcalcetide on human fertility. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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