glatiramer (Copaxone, Glatopa)

• Glatiramer acetate injection (glatiramer) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
• Glatiramer's mechanism of action is not completely understood. Available data suggests that it may work by modifying immune processes by suppressing T-cells (white blood cells of the immune system) that cause inflammation and destruction of nerves in patients with MS . Glatiramer does not cure MS. It decreases the number of MS flares and lesions in the brain.
• The FDA approved glatiramer in December, 1996.

What brand names are available for glatiramer-injection?

Copaxone, Glatopa

Is glatiramer available as a generic drug?

Yes

Do I need a prescription for glatiramer?

Yes

Glatiramer is used for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Common side effects include:

• Injection site pain
• Injection site redness
• Injection site inflammation
• Injection site itching
• Injection site lump
• Shortness of breath
• Itching
• Rash
• Diarrhea
• Lymphadenopathy
• Injection site welt
• Weakness
• Joint pain
• Anxiety
• Nausea
• Flu symptoms

Other side effects include:

• Infections
• Weight gain
• Facial swelling

Possible serious side effects include:

• Palpitations
• Chest pain
• Blood clots
• Skin necrosis (death)
• Increased heart rate
• Vaginal fungal infection
• Allergic reactions

• The recommended dose for treating relapsing forms of MS is 20 mg injected under the skin daily or 40 mg injected under the skin 3 times a week (at least 48 hours apart).

• Drug interactions between glatiramer and other drugs have not been evaluated.
• Available information does not suggest that glatiramer significantly interacts with other MS drugs. However, use of glatiramer with other drugs that also suppress the immune system may increase the risk of serious infection.

• Glatiramer has not been adequately studied in pregnant women.
• It is not known if glatiramer acetate is excreted in human milk.

What preparations of glatiramer-injection are available?

Solution for injection: 20 mg/ml, 40 mg/ml in a single dose, prefilled syringe.

How should I keep glatiramer-injection stored?

• Glatiramer should be stored refrigerated at 2 C to 8 C (36 F to 46 F).
• It also may be stored at room temperature, 15 C to 30 C (59 F to 86 F) for one month if needed.
• Frozen syringes should be discarded.