Serious allergic reactions (anaphylactic reactions) that may be life-threatening or lead to death may happen any time after you start using COPAXONE. These reactions may happen right after your first dose up to years after starting treatment with COPAXONE, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of using COPAXONE. Some signs and symptoms may be the same as those of an immediate post-injection reaction. See What are the possible side effects of COPAXONE?
COPAXONE 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 COPAXONE is safe and effective in children under 18 years of age.
What is the most important information I should know about COPAXONE?
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 COPAXONE. These reactions may happen right after your first dose up to years after starting treatment with COPAXONE, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of using COPAXONE. Some signs and symptoms may be the same as those of an immediate post-injection reaction. See What are the possible side effects of COPAXONE?
Stop using COPAXONE 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 COPAXONE:
What should I tell my healthcare provider before taking COPAXONE?
Before you use COPAXONE, 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 COPAXONE during your pregnancy.
are breastfeeding or plan to breastfeed. It is not known if COPAXONE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using COPAXONE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
COPAXONE may affect the way other medicines work, and other medicines may affect how COPAXONE 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.
What are the possible side effects of COPAXONE?
COPAXONE may cause serious side effects, including:
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 COPAXONE. Call your healthcare provider right away if you have chest pain while using COPAXONE.
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 COPAXONE. 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:
Liver problems. Liver problems, including liver failure, can occur with COPAXONE. Call your healthcare provider right away if you have symptoms, such as:
The most common side effects of COPAXONE are:
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 COPAXONE. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 .
Please read the accompanying Medication Guide .
