Copaxone Special Precautions

COPAXONE PEN should only be administered subcutaneously.
COPAXONE PEN should not be administered by intravenous or intramuscular routes.
The treating physician should explain to the patient that a reaction associated with at least one of the following symptoms may occur within minutes of a COPAXONE PEN injection: vasodilatation (flushing), chest pain, dyspnoea, palpitations or tachycardia (see Adverse Reactions). The majority of these symptoms is short-lived and resolves spontaneously without any sequelae. Should a severe adverse event occur, the patient must immediately stop COPAXONE PEN treatment and contact his/her physician or any emergency doctor. Symptomatic treatment may be instituted at the discretion of the physician.
There is no evidence to suggest that any particular patient groups are at special risk of these reactions. Nevertheless, caution should be exercised when administering COPAXONE PEN to patients with pre-existing cardiac disorders. These patients should be followed up regularly during treatment.
Convulsions and/or anaphylactoid or allergic reactions have been reportedly rarely. Serious hypersensitivity reactions (e.g. bronchospasm, anaphylaxis or urticaria) may rarely occur. If reactions are severe, appropriate treatment should be instituted and COPAXONE PEN should be discontinued.
Glatiramer acetate-reactive antibodies were detected in patients' sera during daily chronic treatment with glatiramer acetate. Maximal levels were attained after an average treatment duration of 3-4 months and, thereafter, declined and stabilised at a level slightly higher than baseline.
There is no evidence to suggest that these glatiramer acetate-reactive antibodies are neutralising or that their formation is likely to affect the clinical efficacy of glatiramer acetate.
In patients with renal impairment, renal function should be monitored while they are treated with COPAXONE PEN. Whilst there is no evidence of glomerular deposition of immune complexes in patients, the possibility cannot be excluded.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.