Glatiramer Acetate
- Atc Codes:L03AX13
- CAS Codes:147245-92-9
- PHARMGKB ID:147245-92-9
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
Brand Names
Europe
Austria: Copaxone; Belgium: Copaxone; Bulgaria: Copaxone; Cyprus: Copaxone; Czech Republic: Copaxone; Denmark: Copaxone; Estonia: Copaxone; Finland: Copaxone; France: Copaxone; Germany: Copaxone; Greece: Copaxone; Hungary: Copaxone; Ireland: Copaxone; Italy: Copaxone; Latvia: Copaxone; Lithuania: Copaxone; Luxembourg: Copaxone; Malta: Copaxone; Netherlands: Copaxone; Poland: Copaxone; Portugal: Copaxone; Romania: Copaxone; Slovakia: Copaxone; Slovenia: Copaxone; Spain: Copaxone; Sweden: Copaxone; UK: Copaxone.
North America
Canada: Copaxone; USA: Copaxone.
Latin America
Argentina: Copaxone; Brazil: Copaxone; Mexico: Copaxone.
Drug combinations
Chemistry
Glatiramer Acetate: (C~5~H~9~NO~4~ C~3~H~7~NO~2~ C~6~H~14~N~2~O~2~ C~9~H~11~NO~3~)~x~ xC~2~H~4~O~2~. The molar fraction of each aa residue ranges as follows: L-Glu 0.129-0.153, L-Ala 0.392-0.462, L-Tyr 0.086-0.100, and L-Lys 0.300-0.374. L-Glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate. CAS-147245-92-9 (1997).
Pharmacologic Category
Biologic Response Modifiers. (ATC-Code: L03AX13).
Mechanism of action
Glatiramer acetate is a mixture of synthetic polypeptides consisting of L-glutamic acid, L-alanine, L-tyrosine, and L-lysine in a fixed molar ratio. Mechanism of action not fully elucidated. Appears to modify immune processes responsible for pathogenesis of multiple sclerosis. Induces and activates drug-specific suppressor T-cells which migrate into CNS and down-regulate immune response (e.g. inflammation) to myelin antigens in periphery.
Therapeutic use
Treatment to reduce frequency of relapses in relapsing-remitting multiple sclerosis. May be useful in patients who do not respond adequately to or who do not tolerate interferon-β.
Pregnancy and lactiation implications
Adverse events not observed in animal studies. There are no adequate, well-controlled studies in pregnant women. Use in pregnancy only if clearly necessary. Excretion in breast milk unknown (use caution).
Unlabeled use
Contraindications
Hypersensitivity to glatiramer acetate, mannitol, or any component of the formulation.
Warnings and precautions
Anaphylaxis accompanied by anti-glatiramer IgE antibodies reported rarely. Possible modification of immune response and interference with useful immune function. Development of IgG antibodies to glatiramer reported in most patients. Injection site reactions reported (anxiety, chest pain or tightness, constriction of the throat, dyspnea, flushing, lipoatrophy, palpitations, skin necrosis, and urticaria). Transient chest pain reported, generally >1 month after initiation of therapy. For SubQ use only, not for I.V. administration.