COPAXONE® (glatiramer acetate injection) is indicated for the reduction
of the frequency of relapses in relapsing-remitting multiple sclerosis, including
patients who have experienced a first clinical episode and have MRI features consistent
with multiple sclerosis.
Additional Safety Information About COPAXONE®
The most common side effects of COPAXONE® are redness, pain, swelling,
itching, or a lump at the site of injection, flushing, rash, shortness of breath,
and chest pain. These reactions are usually mild and seldom require professional
treatment. Be sure to tell your doctor about any side effects.
Some patients report a short-term reaction right after injecting COPAXONE®.
This reaction can involve flushing (feeling of warmth and/or redness), chest tightness
or pain with heart palpitations, anxiety, and trouble breathing. These symptoms
generally appear within minutes of an injection, last about 15 minutes, and go away
by themselves without further problems.
A permanent indentation under the skin at the injection site may occur, due to a
local destruction of fat tissue. Be sure to follow proper injection technique and
inform your doctor of any skin changes.
After you inject COPAXONE®, call your doctor right away if you develop
hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing,
severe pain at the injection site or other uncomfortable changes in your general
health. Do not give yourself any more injections until your doctor tells you to
begin again.
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.