REPLAGAL Concentrate solution for infusion Ref.[6098] Active ingredients: Agalsidase alfa

Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.

Posology

Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes.

Special populations

Elderly patients

Studies in patients over the age of 65 have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established.

Patients with hepatic impairment

No studies have been performed in patients with hepatic impairment.

Patients with renal impairment

No dose adjustment is necessary in patients with renal impairment.

The presence of extensive renal damage (eGFR <60mL/min) may limit the renal response to enzyme replacement therapy. Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended.

Paediatric Population

The safety and efficacy of Replagal in children aged 0-6 years has not yet been established. Currently available data are described in section 5.1 but no recommendation on posology can be made.

In clinical studies of children (7-18 years) who received Replagal 0.2 mg/kg every other week, no unexpected safety issues were encountered (see section 5.1).

Method of administration

For instructions on dilution of the medicinal product before administration, see section 6.6.

Administer the infusion solution over a period of 40 minutes using an intravenous line with an integral filter.

Do not infuse Replagal concomitantly in the same intravenous line with other agents.

In clinical trials doses up to 0.4 mg/kg weekly were used, and their safety profile was not different from the recommended dose of 0.2 mg/kg biweekly.

Shelf life: 2 years.

Chemical and physical in use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C–8°C).

3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap. Pack sizes of 1, 4 or 10 vials.

Not all pack sizes may be marketed.

• Calculate the dose and number of Replagal vials needed.
• Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative or bacteriostatic agent; aseptic technique must be observed. Once diluted, the solution should be mixed gently but not shaken.
• Since no preservative is present, it is recommended that administration is started as soon as possible after dilution.
• The solution should be inspected visually for particulate matter and discolouration prior to administration.
• For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.