Anaphylactic Reactions

Cases of life-threatening and fatal anaphylaxis have been reported with glatiramer acetate. 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 glatiramer acetate[6.2)]. Glatiramer acetateis contraindicated in patients with a history of hypersensitivity reactions to glatiramer acetate, including anaphylaxis [4]. Anaphylaxis can occur at any time following initiation of glatiramer acetatetherapy, from as early as after the first dose, up to years after initiation of treatment. Anaphylaxis occurred within an hour of a glatiramer acetateinjection in most of the reported cases.
• Some signs and symptoms of anaphylactic reactions may overlap with those of immediate post-injection reactions [5.2]. All patients receiving treatment with glatiramer acetate 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 glatiramer acetatemust be immediately discontinued. Unless a clear alternative etiology is identified, glatiramer acetatemust be permanently discontinued [4].