IMPORTANT SAFETY INFORMATION

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.

IMPORTANT SAFETY INFORMATION

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 reaction. 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:

MORE LESS

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.

IMPORTANT SAFETY INFORMATION

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 reaction. 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

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.

Be sure to talk to your healthcare provider if you are pregnant or plan to become pregnant for them to advise if you should take glatiramer acetate during your pregnancy. Be sure to tell your healthcare provider about all of your medications.

Serious side effects may happen right after or within minutes after you inject GLATIRAMER ACETATE INJECTION at any time during your course of treatment. Call your doctor 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 heartbeat; anxiety; breathing problems or tightness in your throat; or swelling, rash, hives, or itching. If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.

Chest pain may occur either as part of the immediate post-injection reaction or by itself. This type of chest pain usually lasts a few minutes or can begin around 1 month after you start using GLATIRAMER ACETATE INJECTION. Call your doctor right away if you experience chest pain.

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

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, or sleepiness.

Some glatiramer acetate products can be used with an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time. 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 product. If you use the wrong autoinjector, you might not get the correct dose of your medicine.

The most common side effects in studies of GLATIRAMER ACETATE INJECTION are skin problems at your injection site, including redness, pain, swelling, itching, or a lump at the site of injection, rash, shortness of breath, flushing (vasodilation), and chest pain. These are not all 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.

Please see Full Prescribing Information, including Boxed WARNING and Medication Guide for GLATIRAMER ACETATE INJECTION 20 mg/mL or GLATIRAMER ACETATE INJECTION 40 mg/mL.

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.



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IMPORTANT SAFETY INFORMATION

MORE LESS

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.

IMPORTANT SAFETY INFORMATION

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 reaction. 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

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.

Be sure to talk to your healthcare provider if you are pregnant or plan to become pregnant for them to advise if you should take glatiramer acetate during your pregnancy. Be sure to tell your healthcare provider about all of your medications.

Serious side effects may happen right after or within minutes after you inject GLATIRAMER ACETATE INJECTION at any time during your course of treatment. Call your doctor 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 heartbeat; anxiety; breathing problems or tightness in your throat; or swelling, rash, hives, or itching. If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.

Chest pain may occur either as part of the immediate post-injection reaction or by itself. This type of chest pain usually lasts a few minutes or can begin around 1 month after you start using GLATIRAMER ACETATE INJECTION. Call your doctor right away if you experience chest pain.

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

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, or sleepiness.

Some glatiramer acetate products can be used with an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time. 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 product. If you use the wrong autoinjector, you might not get the correct dose of your medicine.

The most common side effects in studies of GLATIRAMER ACETATE INJECTION are skin problems at your injection site, including redness, pain, swelling, itching, or a lump at the site of injection, rash, shortness of breath, flushing (vasodilation), and chest pain. These are not all 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.

Please see Full Prescribing Information, including Boxed WARNING and Medication Guide for GLATIRAMER ACETATE INJECTION 20 mg/mL or GLATIRAMER ACETATE INJECTION 40 mg/mL.

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.