Anaphylactic Reactions

Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. 

• Life-threatening and fatal anaphylaxis has been reported with COPAXONE [see Adverse Reactions (6.2)]. COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis [see Contraindications (4)]. Anaphylaxis can occur at any time following initiation of COPAXONE therapy, from as early as after the first dose, up to years after initiation of treatment. Anaphylaxis occurred within an hour of a COPAXONE injection in most of the reported cases.
• Some signs and symptoms of anaphylactic reactions may overlap with those of immediate post-injection reactions [see Warnings and Precautions (5.2)]. All patients receiving treatment with COPAXONE and caregivers should be informed about the signs and symptoms of anaphylactic reactions, and that they must seek immediate emergency medical care in case of experiencing such symptoms. If an anaphylactic reaction occurs, treatment with COPAXONE must be immediately discontinued. Unless a clear alternative etiology is identified, COPAXONE must be permanently discontinued [see Contraindications (4)].