Glatiramer Acetate (3 brand names, 2 dosage forms, 1 route)
Available dosage forms: INJECTABLE, FOR SOLUTION.
Routes of administration: SUBCUTANEOUS.
Brand Names
- COPAXONE
- GLATIRAMER ACETATE
- GLATOPA
Boxed Warning
Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions (5.1)]. COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis. If an anaphylactic reaction occurs, treatment with COPAXONE must be immediately discontinued. Unless a clear alternative etiology is identified, COPAXONE must be permanently discontinued [see Contraindications (4) and Warnings and Precautions (5.1)].
Indications and Usage
COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Contraindications
COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)].
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Anaphylactic Reactions [see Warnings and Precautions (5.1)] Immediate Post-Injection Reaction [see Warnings and Precautions (5.2)] Chest Pain [see Warnings and Precautions (5.3)] Lipoatrophy and Skin Necrosis [see Warnings and Precautions (5.4)] Potential Effects on Immune Response [see Warnings and Precautions (5.5)] Hepatic Injury [see Warnings and Precautions (5.6)]
Mechanism of Action
The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses. There is no evidence that glatiramer acetate does this, but this has not been systematically evaluated [see Warnings and Precautions (5.5)].