A Complex Drug, But Not a Biologic

A biologic is a protein derived from living material used to treat or cure a disease. Because the polypeptides that make up Glatiramer Acetate (GA) are manufactured in the lab, it is not classified as a biologic.4

The mechanism(s) by which GA exerts its effects in patients with MS are not fully understood. GA is a mixture of synthetic polypeptides composed of four amino acids. Given subcutaneously, GA is readily absorbed, and most of a dose is quickly degraded into smaller fragments in the subcutaneous compartment. GA is believed to induce the regulatory cells that inhibit the immunological damage process that occurs in MS.2

PATIENT MEDICATION INFORMATION

GLATIRAMER ACETATE INJECTION 20 mg/mL (once-daily) is used to treat patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including those who have experienced one episode of nervous system symptoms and who have abnormalities on their brain scan that may be the first signs of Multiple Sclerosis.

GLATIRAMER ACETATE INJECTION is not a cure. Patients treated with GLATIRAMER ACETATE INJECTION experience fewer relapses (flare-ups of the disease).

Do not use GLATIRAMER ACETATE INJECTION if: you are allergic to glatiramer or mannitol or the solution in the pre-filled syringe is cloudy, leaking or contains any particles.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GLATIRAMER ACETATE INJECTION.

Talk about any health conditions or problems you may have, including if you: have heart disease; have a history of developing severe allergic reactions; have chronic obstructive pulmonary disease (COPD); have asthma; have kidney and or liver problems; are pregnant, planning to become pregnant, or if you become pregnant while you are using this medication; are nursing; are under 18 years of age.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

These are not all the possible side effects you may feel when taking GLATIRAMER ACETATE INJECTION. If you experience any side effects not listed here, contact your healthcare professional. The most common side effects of GLATIRAMER ACETATE INJECTION are: skin reactions at the injection site including redness, pain, inflammation, itching, swelling, lumps; permanent “dent” under the skin at the injection site, caused by damage to the fatty tissue at that site; rash; hives; headache; a feeling of worry, nervousness, unease (anxiety).

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by: Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice

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