Is Glatiramer Safe in Breastfeeding

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

A synthetic polypeptide of 4 amino acids (l-alanine, l-glutamic, l-lysine and l-tyrosine), similar to myelin which is indicated in recurrences of multiple sclerosis (Ziemssen 2001). Its high molecular weight makes it unlikely it will be excreted in breast milk and due to its protein nature it would be destroyed in the stomach of the infant, not absorbed, so its oral bioavailability is practically zero, except in premature babies and in the immediate neonatal period, where there may be greater intestinal permeability (2016 Almas, Cree 2013). No problems have been observed in breastfeeding infants for periods ranging from 1 to 12 months whose mothers were taking glatiramer (Fragoso 2014, Hellwig 2012 and 2011, Fragoso 2010). Glatiramer injected subcutaneously is hydrolyzed locally in amino acids and short peptides, so there are no appreciable levels of glatiramer in plasma. Severe side effects are unusual. For some authors (Fragoso 2014) glatiramer would be the best multiple sclerosis disease-modifying drug to take during breastfeeding. One in 10 neurologists prescribe it during breastfeeding (Coyle 2004).

Glatiramer is the active portion of the drug, glatiramer acetate. No information is available on the excretion of glatiramer acetate into breastmilk. However, data from the manufacturer indicates that after subcutaneous injection, glatiramer undergoes rapid degradation to amino acids and shorter peptides and that it cannot be detected in the plasma, urine or feces.[1] Furthermore, any glatiramer that did reach the breastmilk would probably be destroyed in the infant's gastrointestinal tract and not absorbed, except perhaps in neonates. Limited information indicates that maternal use of glatiramer acetate does not cause any adverse effects in breastfed infants. The Multiple Sclerosis Centre of Excellence on Reproduction and Child Health considers glatiramer to be "moderately safe" to use during breastfeeding.[2] Glatiramer acetate appears to be the preferred disease-modifying agent for treating multiple sclerosis during breastfeeding.[3]

Nine mothers received glatiramer acetate (dosage not stated) during pregnancy and postpartum for multiple sclerosis and breastfed their infants for an average of 3.6 months (range 1 to 12 months). No infections, signs of inadequate digestion or other important ill effects were reported in their breastfed infants during the neonatal period. Follow-up of the infants at 1 year or longer found no neurological or developmental deficits in the infants except for one otherwise normal infant with delayed language development who had been breastfed for 3 months.[4] Three mothers received glatiramer acetate (dosage not stated) for multiple sclerosis during pregnancy and postpartum. All of their infants were exclusively breastfed for 6 months and no noticeable problems were reported in any of them.[5] In data collected from 4 countries, 41 women received glatiramer acetate and 17 women received interferon during pregnancy and postpartum for treatment of multiple sclerosis. Of these, 63% breastfed (extent not stated) their infants for a mean of 8.8 months. No mention was made of adverse reactions in breastfed infants.[6]