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Articles

Safety in Lactation: Other immunomodulating drugs

21 September 2020Several drugs in this section (dimethyl fumerate, interferon beta, fingolimod, glatiramer, natalizumab) are used in multiple sclerosis (MS) but are not normally interchangeable as they…

Evidence to support the interchangeability of hybrid generic glatiramer (Brabio®) with the original branded version (Copaxone®)

11 January 2019Glatiramer is licensed for the treatment of relapsing forms of multiple sclerosis (MS). A generic version (Brabio®) has recently been launched in the UK which…
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Lactation Safety Information

Yes
Limited published evidence of safety
Low levels of glatiramer anticipated in milk due to the drug’s properties
Glatiramer is broken down into amino acids and other peptides which present no risk to the infant
18 September 2020

New Medicines

GA Depot Relapsing multiple sclerosis (MS) - depot injection formulation

Information

GA Depot
New formulation
Mapi Pharma
Mapi Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Glatiramer acetate acts on innate immune cells, including monocytes, dendritic cells and B cells, which in turn modulate adaptive functions of B and T cells inducing anti-inflammatory and regulatory cytokine secretion.
Prevalence of MS recorded in the UK from 1990 to 2010 increased by about 2.4% per year, reaching 285.8 per 100 000 in women and 113.1 per 100 000 in men by 2010. There was a consistent decrease in incidence of MS reaching 11.52 per 100,000 per year in women and 4.84 per 100,000 per year in men by 2010 [1].
Relapsing multiple sclerosis (MS) - depot injection formulation
Intramuscular