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About Glatiramer Acetate Injection

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About Glatiramer Acetate Injection

What Is Glatiramer Acetate?

Glatiramer acetate is a prescription medication that can be injected subcutaneously to treat relapsing forms of multiple sclerosis (MS).

Every dose of glatiramer acetate is composed of a complex mixture of polypeptides containing four naturally occurring amino acids:

  • L-glutamate
  • L-lysine
  • L-alanine
  • L-tyrosine

Some scientists think that MS may result when the body’s immune system attacks the myelin sheath that surrounds and protects nerve cell axons.1 Although the mechanism of action of glatiramer acetate is not fully known, there is evidence that it may help reduce MS relapses by interrupting this immune system attack.1

What Is Mylan’s Glatiramer Acetate Injection?

Mylan’s Glatiramer Acetate Injection is an FDA-approved therapeutic equivalent to Copaxone® (glatiramer acetate injection), available in two dose strengths.

  • 40 mg/mL for 3-times-a-week injection
  • 20 mg/mL for once-daily injection


This means that Mylan’s Glatiramer Acetate Injection may be substitued for the equivalent dose of Copaxone® and may be expected to have a comparable safety and efficacy profile.2

Like Copaxone®, Mylan’s Glatiramer Acetate Injection is available by prescription only, for injection under the skin.3

Track Injections on Your Mobile Device

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Download the Mylan Smart Injection Tracker app and track your Glatiramer Acetate Injections on your mobile device. Track the injection sites you’ve used and get alerts for missed entries.

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A Complex Drug, But Not a Biologic

You may have seen Mylan’s Glatiramer Acetate Injection incorrectly referred to as a biologic in articles or posts on the web.

According to the FDA, a biologic is a protein derived from living material used to treat or cure disease. Because the polypeptides that make up glatiramer acetate are manufactured in the lab, it is not classified as a biologic.4

INDICATION

GLATIRAMER ACETATE INJECTION is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS).

IMPORTANT SAFETY INFORMATION

Do not take GLATIRAMER ACETATE INJECTION if you are allergic to glatiramer acetate or mannitol.

Some patients report a short-term reaction right after injecting glatiramer acetate.  This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and do not require specific treatment.  There have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, call the emergency phone numbers in your area.

Call your doctor right away if you develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, do not give yourself any more injections until your doctor tells you to begin again.

Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain should only last a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment.

A permanent indentation under the skin (lipoatrophy and, rarely, death of your skin tissue also referred to as necrosis) at the injection site may occur due to local destruction of fat tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes.

The most common side effects in studies of glatiramer acetate are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of GLATIRAMER ACETATE INJECTION. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects that you have while taking GLATIRAMER ACETATE INJECTION.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, Patient Information Leaflet, and Instructions for Use for Glatiramer Acetate Injection 20 mg/mL or Glatiramer Acetate Injection 40 mg/mL.