What is glatiramer acetate?
Glatiramer acetate (brand name Copaxone, Glatopa, and generics) is used to treat relapsing forms of multiple sclerosis (MS) in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).
Glatiramer acetate’s mechanism of action is not fully understood but it is thought to modify immune processes responsible for the development of MS and act locally rather than causing broad immune suppression. Glatiramer acetate injection contains a combination of the acetate salts of four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. These amino acids resemble the myelin protein surrounding nerve fibers and are thought to act as a decoy to divert an immune attack away from your myelin (see How does Copaxone work for multiple sclerosis?). Glatiramer acetate will not cure MS, but it can make relapses occur less often.
Glatiramer acetate belongs to the drug class immunomodulatory agents. It may also be called an immunostimulant.
Glatiramer acetate gained FDA approval on December 20, 1996, under the brand name Copaxone. Generic glatiramer acetate is available and manufacturers include Mylan, Synthon Pharms Inc., and Sandoz (under the name Glatopa).
Glatiramer acetate side effects
The most common side effects of glatiramer acetate are:
- skin problems at your injection site, such as redness, lumps, pain, itching, or swelling
- rash
- shortness of breath
- flushing (vasodilation)
- chest pain.
Serious side effects and warnings
Glatiramer acetate has a Boxed Warning for serious allergic reactions that may occur minutes or years after starting this medicine.
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. These reactions may happen right after your first dose up to years after starting treatment, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of using glatiramer acetate. Some signs and symptoms may be the same as those of an immediate post-injection reaction. Stop using this medicine 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.
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. 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)
- breathing problems or tightness in your throat
- chest pain
- fast heartbeat
- 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-glatiramer acetate 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. 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. 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
- choosing a different injection area each time you use glatiramer acetate.
Liver problems. Liver problems, including liver failure, can occur with glatiramer acetate. Call your healthcare provider right away if you have symptoms, such as:
- nausea
- yellowing of your skin or the white part of your eye
- loss of appetite
- tiredness
- bleeding more easily than normal
- dark-colored urine and pale stools
- confusion
- sleepiness.
It is not known if glatiramer acetate is safe and effective in children aged less than 18 years. Glatiramer acetate is not approved for use by anyone younger than 18 years old.