Question

I am a breastfeeding mother and i want to know if it is safe to use GS 5816? Is GS 5816 safe for nursing mother and child? Does GS 5816 extracts into breast milk? Does GS 5816 has any long term or short term side effects on infants? Can GS 5816 influence milk supply or can GS 5816 decrease milk supply in lactating mothers?

GS 5816 lactation summary

GS 5816 usage has low risk in breastfeeding
  • DrLact safety Score for GS 5816 is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of GS 5816 may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that GS 5816 may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of GS 5816 low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using GS 5816 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 GS 5816 usage in lactation

Usually used 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 (high molecular weight and very high percentage of protein binding) make it very unlikely that significant amounts would pass into breast milk, therefore it would not be necessary to stop breastfeeding when taking this medication on its own or in combination with sofosbuvir (Lactmed 2016). See below the information of these related products:

Answer by DrLact: About GS 5816 usage in lactation

GS 5816 has not been studied in nursing mothers being treated for hepatitis C infection. Because it is greater than 99.5% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. If GS 5816 used alone or in combination with sofosbuvir is required by the mother, it is not a reason to discontinue breastfeeding. Some sources recommend against breastfeeding when GS 5816 is used with ribavirin. Hepatitis C is not transmitted through breastmilk[1][2] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[3][4] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C. Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[1][2]

Synonyms of GS 5816

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.