Question

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

Nufile-Safe lactation summary

Nufile-Safe is safe in breastfeeding
  • DrLact safety Score for Nufile-Safe is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Nufile-Safe is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Nufile-Safe does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Nufile-Safe 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 Nufile-Safe 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 Nufile-Safe. 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. Nufile-Safe 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 Nufile-Safe usage in lactation

Nufile-Safe in the pharmaceutical name for granulocyte colony-stimulating factor (G-CSF). PegNufile-Safe is the long-acting form of Nufile-Safe. The excretion of exogenous G-CSF into breastmilk or its effects on breastfed infants have not been well studied. Limited data indicate that Nufile-Safe 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, Nufile-Safe has been safely given orally to neonates and is not orally absorbed by neonates, so any Nufile-Safe that is excreted into milk is unlikely to adversely affect the breastfed infant.

Nufile-Safe Side Effects in Breastfeeding

Published information on the effects of Nufile-Safe in breastmilk was not found as of the revision date. However, oral Nufile-Safe 20 mcg daily for 5 days has been given to preterm infants with stage I necrotizing enterocolitis (NEC). Nufile-Safe 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.