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Indications and Usage
Glatiramer is indicated for the treatment of relapsing multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Dosage and Administration
Recommended doses of glatiramer are for subcutaneous use only. Do not administer intravenously. Dosing regimen depends on the product strength selected. The recommended dosage is:
Glatiramer 20 mg/mL: administered once daily
Glatiramer 40 mg/mL: administered 3 times a week, at least 48 hours apart
Glatiramer 20 mg/mL and Glatiramer 40 mg/mL are not interchangeable.
Instructions for Use Remove a blister-packed prefilled syringe from the refrigerated carton. Let the prefilled syringe sit at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration before administration. The solution in the syringe should be clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard syringe.
Subcutaneous self-injection sites include the arms, abdomen, buttocks, and thighs. Prefilled syringes are for single use only. Discard unused portion.
Dosage Forms and Strength
Injection: 20 mg per milliliter in single-dose prefilled syringe with white plunger. For subcutaneous use only.
Injection: 40 mg per milliliter in single-dose prefilled syringe with blue plunger. For subcutaneous use only.
Contraindications
Glatiramer is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Glatiramer may cause serious side effects, including:
Immediate post-injection reactions. Serious side effects can occur at any time during treatment, after or within minutes of glatiramer injection. Call your doctor right away if you have any of the following symptoms of a post-injection reaction, including:
Redness (flushing) in the cheeks or other parts of the body
Chest pain
Fast heartbeat
Anxiety
Breathing problems or tightness in the throat
Swelling, rash, hives, or itching
If you have symptoms of an immediate post-injection reaction, do not give yourself more shots until your doctor tells you to.
Chest pain. Chest pain may be part of the immediate reaction after the injection, or it may be itself. This type of chest pain usually lasts a few minutes and may start about 1 month after you start using glatiramer. If you have chest pain while taking glatiramer, call your doctor right away.
Cause damage to your skin. When you take glatiramer, the fatty tissue under the skin's surface is damaged (lipoatrophy), and rarely, death of the skin tissue (necrosis) occurs. Damage to the fatty tissue under the skin may cause "dimples" at the injection site that may not go away. You can reduce your chance of these problems by:
Follow your doctor's instructions for using glatiramer
Choose a different injection area each time you give glatiramer. See Step 4, "Choose Your Injection Area" in the Instructions for Use.
Liver problems. Liver problems, including liver failure, may occur with glatiramer. Call your healthcare provider right away if you have the following symptoms:
Nausea
Loss of appetite
Tiredness
Dark urine and pale stools
Yellowing of the white parts of the skin or eyes
Bleeding more easily than usual
Confusion
Drowsiness
The most common side effects of glatiramer include:
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Skin problems at the injection site include:
Redness
Pain
Swelling
Itching
Bumps
Rush
Shortness of breath
Flushing (vasodilation)
How should I store glatiramer?
Store glatiramer in the refrigerator between 2°C and 8°C.
When you cannot refrigerate glatiramer, you can store it at room temperature between 15°C and 30°C for up to 1 month.
Protect glatiramer from light or heat.
Do not freeze glatiramer syringes. If the syringe freezes, discard it in a sharps disposal container.