GLATIRAMER ACETATE

Immunomodulator (MS)

Brand names: Glatopa, Copaxone

Subcutaneous

Mechanism of Action

12.1 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

Indications

1 INDICATIONS AND USAGE Glatopa 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. Glatopa is indicated for the treatment of relapsing-forms of multiple sclerosis (MS)

to include clinically isolated syndrome

Contraindications

• 4 CONTRAINDICATIONS Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Known hypersensitivity to glatiramer acetate or mannitol ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting ( 5
There is no evidence that glatiramer acetate injection does this, but there has not been a systematic evaluation of this risk
No IgE type antibodies could be detected in any of the 94 sera tested; nevertheless, anaphylaxis can be associated with the administration of most any foreign substance, and therefore, this risk cannot be excluded

Known Side Effects

9 documented side effects by frequency

Injection Site Pain

>10%

Drug Not Working

1-10%

Injection Site Reaction

1-10%

Fatigue

1-10%

Shortness of Breath

1-10%

Falls

1-10%

Nausea

0.1-1%

Dizziness

0.1-1%

Headache

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous