BRABIO

The initiation of glatiramer acetate treatment should be supervised by a neurologist or a physician experienced in the treatment of MS. Posology The recommended dosage in adults is 40 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection three times a week with at least 48 hours apart.

At the present time, it is not known for how long the patient should be treated. A decision concerning long term treatment should be made on an individual basis by the treating physician. 4). Elderly Glatiramer acetate has not been specifically studied in the elderly.

Paediatric population The safety and efficacy of glatiramer acetate in children and adolescents has not been established. There is not enough information available on the use of glatiramer acetate 40 mg/ml TIW in children and adolescents below 18 years of age to make any recommendation for its use.

Therefore, glatiramer acetate 40 mg/ml TIW should not be used in this population. Method of administration Brabio is for subcutaneous use. Patients should be instructed in self-injection techniques and should be supervised by a health- care professional the first time they self-inject and for 30 minutes after.

A different site should be chosen for every injection, so this will reduce the chances of any irritation or pain at the site of the injection. Sites for self-injection include the abdomen, arms, hips and thighs. The MyJECT device is available should the patients want to make their injection with an injection device.

The MyJECT device is an autoinjector to be used with Brabio pre-filled syringes and it has not been tested with other pre-filled syringes. The MyJECT device should be used as recommended in the information provided by the device manufacturer.

Most glatiramer acetate safety data were accumulated for glatiramer acetate 20 mg/ml administered as a subcutaneous injection once daily. This section presents accumulated safety data from four placebo- controlled trials with glatiramer acetate 20 mg/ml administered once daily, and from one placebo- controlled trial with glatiramer acetate 40 mg/ml administered three times a week.

A direct comparison of the safety between glatiramer acetate 20 mg/ml (administered daily) and 40 mg/ml (administered three times per week) in the same study has not been performed. Glatiramer acetate 20 mg/ml (administered once daily) In all clinical trials with glatiramer acetate 20 mg/ml, injection-site reactions were seen to be the most frequent adverse reactions and were reported by the majority of patients receiving glatiramer acetate.

In controlled studies, the proportion of patients reporting these reactions, at least once, was higher following treatment with glatiramer acetate 20 mg/ml (70%) than placebo injections (37%). The most commonly reported injection-site reactions, in clinical trials and in post-marketing experience, were erythema, pain, mass, pruritus, oedema, inflammation, hypersensitivity and rare occurrences of lipoatrophy and skin necrosis.

4). This reaction may occur within minutes of a glatiramer acetate injection. At least one component of this immediate post-injection reaction was reported at least once by 31% of patients receiving glatiramer acetate 20 mg/ml compared to 13% of patients receiving placebo.

Adverse reactions identified from clinical trials and post marketing experience are presented in the table below. Data from clinical trials was derived from four pivotal, double-blind, placebo-controlled clinical trials with a total of 512 patients treated with glatiramer acetate 20 mg/day and 509 patients treated with placebo for up to 36 months.

Glatiramer acetate should only be administered subcutaneously. Glatiramer acetate should not be administered by intravenous or intramuscular routes. 8). 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 glatiramer acetate 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 for these reactions.

Nevertheless, caution should be exercised when administering glatiramer acetate to patients with pre-existing cardiac disorders. These patients should be followed up regularly during treatment. 8). Cases with fatal outcome have been reported.

Some signs and symptoms of anaphylactic reactions may overlap with post-injection reactions. 8). 3). 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.

Rare cases of severe liver injury have been observed (including hepatitis with jaundice, liver failure, and in isolated cases liver transplantation). Liver injury occurred from days to years after initiating treatment with glatiramer acetate.

Most instances of severe liver injury resolved with discontinuation of treatment. In some cases, these reactions have occurred in the presence of excessive alcohol consumption, existing or history of liver injury and use of other potentially hepatotoxic medication.

Patients should be regularly monitored for signs of hepatic injury and instructed to seek immediate medical attention in case of symptoms of liver injury. In case of clinically significant liver injury, discontinuation of glatiramer acetate should be considered.

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