No

Biological, Miscellaneous

Relapsing-remitting type multiple sclerosis; studies indicate that it reduces the frequency of attacks and the severity of disability; appears to be most effective for patients with minimal disability

B

Previous hypersensitivity to any component of the copolymer formulation

>10%:

Cardiovascular: Chest pain (26%)

Local: Pain

1% to 10%:

Cardiovascular: Chest tightness, flushing, tachycardia, vasodilitation

Central nervous system: Anxiety, depression, dizziness

Dermatologic: Erythema (4%), urticaria

Hematologic: Transient eosinophilia

Local: Injection site reactions (6.5%)

Neuromuscular & skeletal: Tremor

Respiratory: Dyspnea

Miscellaneous: Diaphoresis, unintended pregnancy

Well tolerated; no serious toxicities can be anticipated

Reconstituted product contains no preservative, use immediately; store unreconstituted product in refrigerator at 2°C to 8°C (36°F to 46°F); diluent may be stored at room temperature

Glatiramer is a mixture of random polymers of four amino acids; L-alanine, L-glutamic acid, L-lysine and L-tyrosine, the resulting mixture is antigenically similar to myelin basic protein, which is an important component of the myelin sheath of nerves; glatiramer is thought to suppress T-lymphocytes specific for a myelin antigen, it is also proposed that glatiramer interferes with the antigen-presenting function of certain immune cells opposing pathogenic T-cell function

Adults: S.C.: 20 mg daily

May cause anxiety or depression

None reported

No information available to require special precautions

No effects or complications reported

It is essential to provide the patient with proper handling and reconstitution instruction, since they will most likely have to self-administer the drug for an extended period

Injection: Single-use vials containing 20 mg of glatiramer and 40 mg mannitol; packaged in 2 mL vials along with 1 mL vial of diluent (sterile water for injection)