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Glatiramer Acetate Injection

Important Safety Information

Glatiramer Acetate Injection, for subcutaneous use

Glatiramer acetate injection is a prescription medicine that is 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.

Store glatiramer acetate injection in the refrigerator between 36°F to 46°F (2°C to 8°C).

When you are not able to refrigerate glatiramer acetate injection, you may store it for up to 1 month at room temperature between 59°F to 86°F (15°C to 30°C).

Protect glatiramer acetate injection from light or high temperature.

Do not freeze glatiramer acetate syringes. If a syringe freezes, throw it away in a sharps disposal container.

Keep glatiramer acetate injection and all medicines out of the reach of children.

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. These reactions may happen right after your first dose up to years after starting treatment with glatiramer acetate injection, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of using glatiramer acetate injection. Some signs and symptoms may be the same as those of an immediate post-injection. See What are the possible side effects of glatiramer acetate injection?

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
  • fainting, feeling dizzy or faint

What is glatiramer acetate injection?

Glatiramer acetate injection is a prescription medicine that is 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.

Do not take glatiramer acetate injection:

If you are allergic to glatiramer acetate or mannitol. Serious allergic reactions including life-threatening or anaphylactic reactions that can lead to death have happened. See the end of this leaflet for a complete list of the ingredients in glatiramer acetate injection.

Before you use glatiramer acetate injection, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. Talk to your healthcare provider who will advise if you should take glatiramer acetate injection during your pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if glatiramer acetate passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using glatiramer acetate injection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Glatiramer acetate injection may affect the way other medicines work, and other medicines may affect how glatiramer acetate injection works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use glatiramer acetate injection?

  • For detailed instructions, see the Instructions for Use at the end of this leaflet for complete information on how to use glatiramer acetate injection.
  • Your healthcare provider will tell you how much glatiramer acetate injection to use and when to use it.
  • Glatiramer acetate injection is given by injection under your skin (subcutaneously).
  • Use glatiramer acetate injection exactly as your healthcare provider tells you to use it.
  • Since every body type is different, talk with your healthcare provider about the injection areas that are best for you.
  • You should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. This might be at your doctor’s office or with a visiting home health nurse who will teach you how to give your glatiramer acetate injections.
  • Check with your healthcare provider when you fill or refill your medicine to make sure the autoinjector you have is meant to be used with your glatiramer acetate products. If you use the wrong autoinjector, you might not get the correct dose of your medicine. Contact the manufacturer of your glatiramer acetate product to find out if there is an autoinjector that is meant to be used with your glatiramer acetate product.

Read your Instructions for Use and talk to your healthcare provider about the best way for you to use glatiramer acetate injection.

What are the possible side effects of glatiramer acetate injection?

Glatiramer acetate injection may cause serious side effects, including:

  • Immediate Post-Injection Reactions. Serious side effects may happen right after or within minutes after you inject glatiramer acetate injection at any time during your course of treatment. Some signs and symptoms may be the same as those of a serious allergic reaction (anaphylaxis). See What is the most important information I should know about glatiramer acetate injection? Call your healthcare provider right away if you have any of these immediate post- injection reaction symptoms including:
  • redness to your cheeks or other parts of the body (flushing)
  • chest pain
  • fast heart beat
  • anxiety
  • breathing problems or tightness in your throat
  • swelling, rash, hives, or itching

If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a healthcare provider tells you to.

  • Chest Pain. You can have chest pain as part of an immediate post-injection reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around 1 month after you start using glatiramer acetate injection. Call your healthcare provider right away if you have chest pain while using glatiramer acetate injection.
  • Damage to your skin. Damage to the fatty tissue just under your skin’s surface (lipoatrophy) and, rarely, death of your skin tissue (necrosis) can happen when you use glatiramer acetate injection. Damage to the fatty tissue under your skin can cause a “dent” at the injection site that may not go away. You can reduce your chance of developing these problems by:
    • following your healthcare provider’s instructions for how to use glatiramer acetate injection
    • choosing a different injection area each time you use glatiramer acetate injection. See Step 4 in the Instructions for Use, “Choose your injection area”.
  • Liver problems. Liver problems, including liver failure, can occur with glatiramer acetate injection. Call your healthcare provider right away if you have symptoms, such as:
    • nausea
    • loss of appetite
    • tiredness
    • dark colored urine and pale stools
    • yellowing of your skin or the white part of your eye
    • bleeding more easily than normal
    • confusion
    • sleepiness

The most common side effects of glatiramer acetate injection are:

  • skin problems at your injection site including:
    • redness
    • pain
    • swelling
    • lumps
    • itching
  • rash
  • shortness of breath
  • flushing (vasodilation)
  • chest pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of glatiramer acetate injection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about 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.