Epoetin beta-methoxy polyethylene glycol Pregnancy and Breastfeeding Warnings

Brand names: Mircera

Medically reviewed by Drugs.com. Last updated on May 19, 2023.

Epoetin beta-methoxy polyethylene glycol Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-The limited available data (case and post marketing reports) in pregnant women are insufficient to identify major birth defects, miscarriage, or maternal/fetal adverse effects.
-Pregnancy associated adverse outcomes from chronic kidney disease include hypertension, pre-eclampsia, miscarriage, premature birth, low birth weight, polyhydramnios, and intrauterine growth restriction.
-In animal lactation and pregnancy studies, offspring were adversely affected at doses 17 times the maximum recommended human dose.

Animal studies during gestation, including organogenesis, of 50 mcg/kg [417 times the recommended human dose (RHD)] subcutaneously every 3 days showed bone malformations (missing caudal vertebrae resulting in a thread-like tail in a rat; first digit, metacarpal and phalanx on each forelimb, and pollex absent; fused fourth and fifth cervical vertebrae) and dose-related fetal weight reductions; doses 42 times the RHD and higher every 3 days exaggerated pharmacodynamic effects in dams. Once weekly dosing of up to 167 times the RHD subcutaneously given during pregnancy and lactation did not adversely affect pre- or post-natal pregnancy parameters, natural delivery, or litter observations, but death and significant growth rate reductions were seen in the offspring during lactation and weaning, at 67 and 167 times the RHD. Growth rate reduction in the offspring is evident at 17 times the RHD. No dose group showed remarkable effect on reflex, physical and cognitive development, or reproductive performance in the offspring. No dose was determined that did not adversely affect the dam or offspring. 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 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.

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Epoetin beta-methoxy polyethylene glycol Breastfeeding Warnings

Benefit should outweigh risk.

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

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.
-Endogenous erythropoietin is found in human milk.
-Since this drug appears in animal milk, it is likely to appear in human milk.
-In animal lactation and pregnancy studies, offspring were adversely affected at doses 17 times the maximum recommended human dose.
-Adverse effects were seen in animal trial pups (decreased weight gain, developmental delay, slightly increased mortality, increased pale liver and/or lung incidence, increased abdominal distension post weaning).
-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.
-According to some authorities a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

In animal studies administering three times the recommended human dose during lactation, this drug was found in the milk 4 hours post dose, with maximum concentration reached at 48 hours post dose; the maximum milk concentration was 10-fold lower than the serum concentration. Animal milk concentrations do not necessarily predict human milk concentrations. Once weekly dosing of up to 167 times the RHD subcutaneously given during pregnancy and lactation did not adversely affect pre- or post-natal pregnancy parameters, natural delivery, or litter observations, but death and significant growth rate reductions were seen in the offspring during lactation and weaning at 67 and 167 times the RHD.

See references

Further information

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