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Indication

Glatopa^® (glatiramer acetate injection) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

Do not take Glatopa^® if you are allergic to glatiramer acetate, mannitol, or any of the ingredients in Glatopa.

Some patients report a short-term reaction right after or within minutes after injecting glatiramer acetate. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain, fast heartbeat, anxiety, and trouble breathing. These symptoms generally appear within seconds to minutes of an injection, last about 15 minutes, and do not require specific treatment. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, call the emergency phone number 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. Tell your doctor if you experience chest pain that lasts for a long time or feels very intense.

A permanent indentation under the skin (lipoatrophy) or, rarely, 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 injection 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. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects you have while taking Glatopa.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for Glatopa.