Question

I am a breastfeeding mother and i want to know if it is safe to use KRN 8601? Is KRN 8601 safe for nursing mother and child? Does KRN 8601 extracts into breast milk? Does KRN 8601 has any long term or short term side effects on infants? Can KRN 8601 influence milk supply or can KRN 8601 decrease milk supply in lactating mothers?

KRN 8601 lactation summary

KRN 8601 is safe in breastfeeding
  • DrLact safety Score for KRN 8601 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of KRN 8601 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that KRN 8601 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of KRN 8601 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 KRN 8601 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 KRN 8601. 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. KRN 8601 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 KRN 8601 usage in lactation

KRN 8601 in the pharmaceutical name for granulocyte colony-stimulating factor (G-CSF). PegKRN 8601 is the long-acting form of KRN 8601. The excretion of exogenous G-CSF into breastmilk or its effects on breastfed infants have not been well studied. Limited data indicate that KRN 8601 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, KRN 8601 has been safely given orally to neonates and is not orally absorbed by neonates, so any KRN 8601 that is excreted into milk is unlikely to adversely affect the breastfed infant.

KRN 8601 Side Effects in Breastfeeding

Published information on the effects of KRN 8601 in breastmilk was not found as of the revision date. However, oral KRN 8601 20 mcg daily for 5 days has been given to preterm infants with stage I necrotizing enterocolitis (NEC). KRN 8601 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.