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About Glatiramer
Injection Training
FAQs
MS Resources
Safety Information
Prescribing Info

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⚠ IMPORTANT SAFETY INFORMATION — Read before using this medication.

Glatiramer Acetate Injection, for subcutaneous use

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. It is not known if glatiramer acetate injection is safe and effective in children under 18 years of age.

What is the most important information I should know about glatiramer acetate injection?

Serious allergic reactions (anaphylactic reactions). Serious allergic reactions that may be life-threatening or lead to death may happen any time after you start using glatiramer acetate injection, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of use. Stop using glatiramer acetate injection and get emergency help right away if you have: widespread rash; swelling of the face, eyelids, lips, mouth, throat, or tongue; sudden shortness of breath, difficulty breathing, or wheezing; uncontrolled shaking (convulsions); trouble swallowing or speaking; or fainting, feeling dizzy or faint. Do not take glatiramer acetate injection if you are allergic to glatiramer acetate or mannitol.

Serious side effects may happen right after or within minutes of injection at any time during treatment, including flushing, chest pain, fast heartbeat, anxiety, breathing problems, or swelling/rash/hives/itching.

Chest pain may occur as part of a post-injection reaction or by itself and can begin around 1 month after starting treatment. Call your healthcare provider right away if you experience chest pain.

Damage to your skin (lipoatrophy and, rarely, necrosis) can occur at injection sites. Rotate injection areas each use to reduce this risk.

Liver problems, including liver failure, can occur. Call your healthcare provider right away if you have nausea, loss of appetite, tiredness, dark urine, pale stools, yellowing of skin or eyes, easy bruising, confusion, or sleepiness.

The most common side effects are injection site reactions (redness, pain, swelling, lumps, itching), rash, shortness of breath, flushing, and chest pain. These are not all possible side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Ajenat Pharmaceuticals, LLC at +1-727-234-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Boxed WARNING and Medication Guide, for Glatiramer Acetate Injection 20 mg/mL or 40 mg/mL.

Please see Full Prescribing Information:

GLATIRAMER ACETATE INJECTION 20 mg/mL

GLATIRAMER ACETATE INJECTION 40 mg/mL

GlatiramerAcetateInjections.com

Ajenat Pharmaceuticals, LLC Tampa, FL 33602

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