Question

I am a breastfeeding mother and i want to know if it is safe to use TMC 435 sodium? Is TMC 435 sodium safe for nursing mother and child? Does TMC 435 sodium extracts into breast milk? Does TMC 435 sodium has any long term or short term side effects on infants? Can TMC 435 sodium influence milk supply or can TMC 435 sodium decrease milk supply in lactating mothers?

TMC 435 sodium lactation summary

TMC 435 sodium usage has low risk in breastfeeding
  • DrLact safety Score for TMC 435 sodium is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of TMC 435 sodium may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that TMC 435 sodium may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of TMC 435 sodium low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using TMC 435 sodium We suggest monitoring 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 TMC 435 sodium usage in lactation

Used alone or in combination with sofosbuvir in the treatment of hepatitis C. Since the last update we have not found published data on its excretion in breast milk. Its pharmacokinetic data (slightly elevated molecular weight and very high percentage of plasma protein binding) make it very unlikely that significant amounts will pass into milk, so that although there is disagreement (Thompson 2016), other experts believe that treatment with Simeprevir, on its own or in combination with Sofosbuvir is not contraindicated during breastfeeding (LactMed 2016, See below the information of these related products:

Synonyms of TMC 435 sodium

TMC 435 sodium salt
Sovriad
UNII-16U7H60184
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.