Is Glatiramer Acetate compatible with breastfeeding? Do we have alternatives for Glatiramer Acetate?

Glatiramer Acetate

October 11, 2017 (Low Risk)

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).

Alternatives

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Writings

  • Γκλατιραμέρη οξική (Greek)
  • Глатирамер Ацетат (Cyrillic)
  • 酢酸グラチラマー (Japanese)
  • C254H422N70O72 (Molecular formula)
  • l-Glutamic acid polymer with l-alanine, l-lysine and l-tyrosine, acetate (Chemical name)
  • L03AX13 (ATC Code/s)

Drug trade names

References

  1. Alroughani R, Altintas A, Al Jumah M, Sahraian M, Alsharoqi I, AlTahan A, Daif A, Dahdaleh M, Deleu D, Fernandez O, Grigoriadis N, Inshasi J, Karabudak R, Taha K, Totolyan N, Yamout BI, Zakaria M, Bohlega S. Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks. Mult Scler Int. 2016Abstract Full text (link to original source) Full text (in our servers)
  2. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016Abstract Full text (link to original source) Full text (in our servers)
  3. Fragoso YD. Glatiramer acetate to treat multiple sclerosis during pregnancy and lactation: a safety evaluation. Expert Opin Drug Saf. 2014Abstract
  4. Fragoso YD, Boggild M, Macias-Islas MA, Carra A, Schaerer KD, Aguayo A, de Almeida SM, Alvarenga MP, Alvarenga RM, Alves-Leon SV, Arruda WO, Brooks JB, Comini-Frota ER, Ferreira ML, Finkelsztejn A, Finkelsztejn JM, de Freitas LD, Gallina AS, da Gama PD, Georgetto S, Giacomo MC, Gomes S, et al. The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Clin Neurol Neurosurg. 2013Abstract
  5. Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler. 2013Abstract Full text (link to original source) Full text (in our servers)
  6. Hellwig K, Haghikia A, Rockhoff M, Gold R. Multiple sclerosis and pregnancy: experience from a nationwide database in Germany. Ther Adv Neurol Disord. 2012Abstract Full text (link to original source) Full text (in our servers)
  7. Hellwig K, Gold R. Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J Neurol. 2011Abstract
  8. Fragoso YD, Finkelsztejn A, Kaimen-Maciel DR, Grzesiuk AK, Gallina AS, Lopes J, Morales NM, Alves-Leon SV, de Almeida SM. Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series. CNS Drugs. 2010Abstract
  9. Coyle PK, Christie S, Fodor P, Fuchs K, Giesser B, Gutierrez A, Lynn J, Weinstock-Guttman B, Pardo L; Women Neurologists MS Initiative. Multiple sclerosis gender issues: clinical practices of women neurologists. Mult Scler. 2004Abstract
  10. Ziemssen T, Neuhaus O, Hohlfeld R. Risk-benefit assessment of glatiramer acetate in multiple sclerosis. Drug Saf. 2001Abstract