Before Initiation of Therapy :
- Negative pregnancy test and counsel with regards to contraception
Monitoring During Therapy :
- Examine skin periodically for evidence of lipoatrophy.
Immediate Post-Injection Reaction :
Approximately 14% of Multiple Sclerosis patients
exposed to Copaxone in 4 placebo-controlled studies reported a post-injection reaction
immediately following subcutaneous injection of Copaxone compared to 2% for placebo
treated patients. An immediate post-injection reaction is a constellation of symptoms occurring
immediately after injection that includes at least two of the following:
- chest pain
- constriction of the throat and urticaria
These symptoms were invariably transient, self-limited, did
not require specific treatment and in general, arose several months after initiation of treatment,
although they may occur earlier in the course of treatment.
At Injection Sites :
localized lipoatrophy and, rarely, injection site skin necrosis have been
reported during clinical trials and post-marketing experience.
Lipoatrophy may occur after treatment onset (sometimes as early as several months) and may be
permanent. There is no known therapy for lipoatrophy. To assist in possibly minimizing these
events the patient should be advised to follow proper injection technique and to rotate injection
areas and sites on a regular basis