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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Glatiramer

Last Revision: June 15, 2020.

Estimated reading time: 2 minutes

CASRN: 28704-27-0

image 135023025 in the ncbi pubchem databaseimage 135228528 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

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. Glatiramer acetate is generally considered safe by most experts and appears to be one of the preferred disease-modifying agents for treating multiple sclerosis during breastfeeding.[2-5]

Drug Levels

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 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.[6]

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.[7]

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.[8]

Thirty-four women with multiple sclerosis who were treated with glatiramer daily during breastfeeding were followed by the German Multiple Sclerosis and Pregnancy Registry. One woman received both interfern beta-1a every other day and glatiramer daily. Most infants were also exposed during pregnancy. Infants were breastfed for an average of 7.8 months (range 0.5 to 19.9 months) during glatiramer therapy. Infants were followed for 1 year and most developed normally; the percentages of infants with developmental delay, courses of antibiotics and hospitalizations did not differ from the reference German population. No conditions attributable to glatiramer were found.[5]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.
Ziemssen T, Neuhaus O, Hohlfeld R. Risk-benefit assessment of glatiramer acetate in multiple sclerosis. Drug Saf. 2001;24:979–90. [PubMed: 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. [PubMed: 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. [PubMed: 25176273]
4.
Thöne J, Thiel S, Gold R, et al. Treatment of multiple sclerosis during pregnancy - safety considerations. Expert Opin Drug Saf. 2017;16:523–34. [PubMed: 28333552]
5.
Ciplea AI, Langer-Gould A, Stahl A, et al. Safety of potential breast milk exposure to IFN-beta or glatiramer acetate: One-year infant outcomes. Neurol Neuroimmunol Neuroinflamm. 2020;7:e757 [PMC free article: PMC7251509] [PubMed: 32434802]
6.
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. [PubMed: 20806993]
7.
Hellwig K, Gold R. Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J Neurol. 2011;258:502–3. [PubMed: 20878174]
8.
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. [PubMed: 22633835]

Substance Identification

Substance Name

Glatiramer

CAS Registry Number

28704-27-0 147245-92-9

Drug Class

Breast Feeding

Lactation

Immunologic Adjuvants

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. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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