Question

I am a breastfeeding mother and i want to know if it is safe to use MYL-1401O? Is MYL-1401O safe for nursing mother and child? Does MYL-1401O extracts into breast milk? Does MYL-1401O has any long term or short term side effects on infants? Can MYL-1401O influence milk supply or can MYL-1401O decrease milk supply in lactating mothers?

MYL-1401O lactation summary

MYL-1401O is unsafe in breastfeeding
  • DrLact safety Score for MYL-1401O is 5 out of 8 which is considered Unsafe as per our analyses.
  • A safety Score of 5 indicates that usage of MYL-1401O may cause serious side effects in breastfed baby.
  • Our study of different scientific research indicates that MYL-1401O may cause moderate to high side effects or may affect milk supply in lactating mother.
  • Our suggestion is to use safer alternate options rather than using MYL-1401O .
  • It is recommended to evaluate the advantage of not breastfeeding while using MYL-1401O Vs not using MYL-1401O And continue breastfeeding.
  • While using MYL-1401O Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to 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 MYL-1401O usage in lactation

Anticuerpo monoclonal recombinante inmunoglobulina G1 dirigido contra la proteína producida por el gen HER2 (receptor 2 de factor de crecimiento epidérmico humano) sobreexpresado en 25 a 30% de cánceres de pecho. A fecha de última actualización no encontramos datos publicados sobre su excreción en leche materna. Su elevado peso molecular y su naturaleza protéica hacen prácticamente imposible tanto el paso a leche como la absorción intestinal por parte del lactante: Su baja biodisponibilidad oral dificulta el paso a plasma del lactante a partir de la leche materna ingerida, salvo en prematuros y periodo neonatal inmediato, en los que puede haber mayor permeabilidad intestinal. Aunque posiblemente seguro durante la lactancia, su muy larga semivida de eliminación (18 a 28,5 días) y sus posibles efectos secundarios hacen que hasta conocer más datos publicados sobre este fármaco pueda ser prudente no amamantar. El periodo de "lavado" (tiempo que tarda el medicamento en eliminarse por completo del organismo) a esperar a amamantar serían 143 días (5 vidas medias) tras la última dosis. A tener en cuenta que la vida media de MYL-1401O emtansina es mucho más corta, de tan sólo unos 4 días.

Answer by DrLact: About MYL-1401O usage in lactation

No information is available on the clinical use of MYL-1401O during breastfeeding. Because MYL-1401O is a large protein molecule with a molecular weight of 145,531, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, MYL-1401O should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.[1] The manufacturer recommends that breastfeeding be discontinued during MYL-1401O therapy and for 7 months after the last dose. MYL-1401O is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[2][3] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[4] None of the studies measured IgG activity.

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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.