Glatiramer use while Breastfeeding
Drugs containing Glatiramer: Copaxone, Glatopa
Glatiramer Levels and Effects while Breastfeeding
Summary of Use during Lactation
No information is available on the excretion of glatiramer 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. 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 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. Glatiramer appears to be the preferred disease-modifying agent for treating multiple sclerosis during breastfeeding.
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Nine mothers received glatiramer (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.
Three mothers received glatiramer (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.
In data collected from 4 countries, 41 women received glatiramer 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.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
Immune Globulin, Interferon Beta
1. Ziemssen T, Neuhaus O, Hohlfeld R. Risk-benefit assessment of glatiramer acetate in multiple sclerosis. Drug Saf. 2001;24:979-90. PMID: 11735654
2. Bove R, Alwan S, Friedman JM et al. Management of multiple sclerosis during pregnancy and the reproductive years: a systematic review. Obstet Gynecol. 2014;124:1157-68. PMID: 25415167
3. Fragoso YD. Glatiramer acetate to treat multiple sclerosis during pregnancy and lactation: A safety evaluation. Expert Opin Drug Saf. 2014;13:1743-8. PMID: 25176273
4. Fragoso YD, Finkelsztejn A, Kaimen-Maciel DR et al. Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series. CNS Drugs. 2010;24:969-76. PMID: 20806993
5. Hellwig K, Gold R. Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J Neurol. 2011;258:502-3. PMID: 20878174
6. Fragoso YD, Boggild M, Macias-Islas MA et al. The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Clin Neurol Neurosurg. 2013;115:154-9. PMID: 22633835
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