Question

I am a breastfeeding mother and i want to know if it is safe to use Nivestim? Is Nivestim safe for nursing mother and child? Does Nivestim extracts into breast milk? Does Nivestim has any long term or short term side effects on infants? Can Nivestim influence milk supply or can Nivestim decrease milk supply in lactating mothers?

Nivestim lactation summary

Nivestim is safe in breastfeeding
  • DrLact safety Score for Nivestim is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Nivestim is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Nivestim does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Nivestim safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Nivestim usage in lactation

Non-glycosylated stimulating factor of granulocyte colonies (G-CSF) which is obtained by recombinant technology.The naturally occurring product is found in breast milk. A very high molecular weight explains the insignificant or no excretion into milk that has been observed both with Lenograstim and Nivestim. Its low oral bioavailability hampers absorption into infant plasma from the breast milk ingested, as for their proteic nature it is degraded in the gastrointestinal tract, not being absorbed. Nivestim is not absorbed by the infant's gut even during the neonatal period or prematurity. The granulocyte colony-stimulating factor has been used in premature newborns, both on prevention and treatment of neonatal sepsis and/or necrotizing enterocolitis without adverse effects being observed among treated infants. The bovine G-CSF is found in the usual diet of meat eaters.

Answer by DrLact: About Nivestim usage in lactation

Nivestim in the pharmaceutical name for granulocyte colony-stimulating factor (G-CSF). PegNivestim is the long-acting form of Nivestim. The excretion of exogenous G-CSF into breastmilk or its effects on breastfed infants have not been well studied. Limited data indicate that Nivestim and a similar G-CSF product, lenograstim, are poorly excreted into breastmilk and are undetectable by 3 days after an injection. Some authors recommend withholding breastfeeding for this period of time.[1] However, Nivestim has been safely given orally to neonates and is not orally absorbed by neonates, so any Nivestim that is excreted into milk is unlikely to adversely affect the breastfed infant.

Nivestim Side Effects in Breastfeeding

Published information on the effects of Nivestim in breastmilk was not found as of the revision date. However, oral Nivestim 20 mcg daily for 5 days has been given to preterm infants with stage I necrotizing enterocolitis (NEC). Nivestim appeared to halt progression to more severe stages of NEC in this small study.[6]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.