Glatiramer Acetate - MS Research Australia

Glatiramer Acetate

Glatiramer Acetate

Administration Route: Injection
Injection site:
Frequency: Three times a week
TGA approval date: Dec 2003
PBS listed: Yes
Mechanism of action The mechanism of action is not clear. Administration of glatiramer acetate shifts the population of T cells from proinflammatory Th1 cells to regulatory Th2 cells that suppress the inflammatory response.Given its resemblance to myelin basic protein, glatiramer acetate may also act as a decoy, diverting an autoimmune response against myelin.
%reduction in relapse rate, impact of progression 29% RRR in annual relapes rate,33% RRR for new Gad Lesions, 31% RRR new T2 lesions, 11% RRR Brain atrophy, 12% RRR disability
Pregnancy Category B1
Safe in Pregnancy Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Breastfeeding (information predominatly from  LACTMED database) 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.[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 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 appears to be the preferred disease-modifying agent for treating multiple sclerosis during breastfeeding.[3]
Monitoring requirements No monitoring required
Potential side effects (not a comprehensive list) Skin site reactions, immediate post-injection reaction, lipoatrophy.
Manufacturer Teva
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