THERAPY

Copaxone

Glatiramer Acetate

Protocols

Before Initiation of Therapy :

  • Negative pregnancy test and counsel with regards to contraception

Monitoring During Therapy :

  • Examine skin periodically for evidence of lipoatrophy.

     

Product Monograph

Specific Concerns

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:

  • ‍flushing
  • ‍chest pain
  • ‍palpitations
  • ‍anxiety
  • ‍dyspnea
  • ‍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