I am a breastfeeding mother and i want to know if it is safe to use Omalizumab? Is Omalizumab safe for nursing mother and child? Does Omalizumab extracts into breast milk? Does Omalizumab has any long term or short term side effects on infants? Can Omalizumab influence milk supply or can Omalizumab decrease milk supply in lactating mothers?
- DrLact safety Score for Omalizumab is 3 out of 8 which is considered Low Risk as per our analyses.
- A safety Score of 3 indicates that usage of Omalizumab may cause some minor side effects in breastfed baby.
- Our study of different scientific research indicates that Omalizumab may cause moderate to no side effects in lactating mother.
- Most of scientific studies and research papers declaring usage of Omalizumab low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
- While using Omalizumab 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.
Monoclonal antibody against immunoglobulin E (IgE).It is an immunoglobulin G (IgG) of huge molecular weight that binds with great affinity to IgE, blocking it, forming IgG-IgE complexes of even larger size and molecular weight. Since the last update, we have not found published data on its excretion in breast milk. Its high molecular weight makes its excretion in milk very unlikely. Its low oral bioavailability would hinder its transfer to infant plasma from ingested breast milk since, due to its protein nature, it degrades in the gastrointestinal tract, and is not absorbed, except in premature infants and the immediate neonatal period, when there may be greater intestinal permeability. It is known that in non-human primates (cynomolgus monkeys) it is excreted in very small amounts: levels of omalizumab in milk were 0.15% (EMA 2016) or 1.5% (Grunewald 2015, FDA 2007) with respect to maternal serum concentration. Its use is authorized in children from 6 years of age (EMA 2016, Pediamecum 2015). Other monoclonal antibodies of similar structure and molecular weight (adalimumab, certolizumab, infliximab) are known not to be excreted in breast milk in clinically significant amounts and do not harm the infant, and are therefore considered compatible with breastfeeding. See below the information of these related products:
No information is available on the clinical use of omalizumab during breastfeeding. Because omalizumab is a large protein molecule with a molecular weight of 145,058, 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, omalizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
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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.