| COPAXONE®: Descriptives1 |
|
Method of administration |
Subcutaneous (under the skin) injection |
| Indication |
For the reduction of relapses in relapsing-remitting multiple sclerosis |
|
Needle size |
½" length |
|
Delivery Information |
Prefilled syringes–premixed and ready to use |
|
Injection aid(s) |
autoject® 2 for glass syringe |
|
Pregnancy category |
Category B
(when
administered to pregnant animals, there was no detected harm to the fetus)
|
|
Black box warning |
No |
*As suggested by current data.
| COPAXONE®: Side effects/reactions1 |
| Clinically significant difference in flu-like symptoms when compared to placebo (an inactive substance) |
No |
| Fatigue/Malaise (bodily discomfort) increased while on therapy |
No |
| Warning for use in people with depression |
No |
| Warning for use in people with suicidal thoughts |
No |
| Warning or precaution for liver impairment |
No |
| Recommended monitoring of liver function or complete blood count |
No |
| Associated with localized skin reactions |
Yes |
| Associated with neutralizing antibodies2 (proteins produced by the body that may decrease the effectiveness of therapy) |
No |
Additional important information about COPAXONE®
The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. 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.
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