Question

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

TMC 435 sodium salt lactation summary

TMC 435 sodium salt usage has low risk in breastfeeding
  • DrLact safety Score for TMC 435 sodium salt 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 salt may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that TMC 435 sodium salt may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of TMC 435 sodium salt low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using TMC 435 sodium salt 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 salt 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 salt

TMC 435 sodium
Sovriad
UNII-16U7H60184
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