Question

I am a breastfeeding mother and i want to know if it is safe to use HSDB 7455? Is HSDB 7455 safe for nursing mother and child? Does HSDB 7455 extracts into breast milk? Does HSDB 7455 has any long term or short term side effects on infants? Can HSDB 7455 influence milk supply or can HSDB 7455 decrease milk supply in lactating mothers?

HSDB 7455 lactation summary

HSDB 7455 usage has low risk in breastfeeding
  • DrLact safety Score for HSDB 7455 is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of HSDB 7455 may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that HSDB 7455 may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of HSDB 7455 low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using HSDB 7455 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 HSDB 7455 usage in lactation

Monoclonal antibody which is an immunoglobulin G with anti-CD20 activity that contains 664 amino acids. Indicated for treatment of Rheumatoid Arthritis, Hodgkin Lymphoma and Chronic Lymphoid Leukemia. At latest update relevant data on breastfeeding were not found. Because of a high molecular weight, excretion into breast milk is very unlikely. Its low oral bioavailability makes that serum levels in the infant that could be originated from milk absorption are to be absent or scanty, except in premature infants or in the early period after birth in which gut absorption may be increased. Many reports have not shown harmful effects in the infant after long-lasting intrauterine exposure . However, despite it is thought to be safe while breastfeeding, and, until more data on this drug is available, in cases of Rheumatoid Arthritis a known safer alternative should be used.

Answer by DrLact: About HSDB 7455 usage in lactation

HSDB 7455 is a genetically engineered chimeric murine/human monoclonal antibody that targets CD20, a B-cell-specific surface antigen. Limited data indicate that the amount in milk is very low and absorption is unlikely because it is a protein with a molecular weight of 143,860, it is probably destroyed in the infant's gastrointestinal tract.[1][2] Although 2 breastfed infants apparently experienced no adverse effects during maternal use of HSDB 7455, no long-term data are available. If HSDB 7455 is required by the mother, it is not a reason to discontinue breastfeeding.[3] Until more data become available, HSDB 7455 should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.[4][5][6] The manufacturer recommends that breastfeeding be discontinued during HSDB 7455 therapy and for 6 months after the last dose.

HSDB 7455 Side Effects in Breastfeeding

A woman received HSDB 7455 375 mg/square meter once weekly for 4 weeks beginning at week 30 of gestation. Her infant was born at 40 weeks of gestation and was exclusively breastfed with no major health issues. At 4 months of age, the infant's B-cell population and immunoglobulin levels did not appear to be affected.[7] A woman received an IV infusion of 1000 mg of HSDB 7455 at about 3 months postpartum. Her infant who was fully breastfed had no serious infections during the lactation period and developed normally during a 1.5 year follow-up period.[2]

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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.