REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML [SIN16197P]

Product Info

REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML

[SIN16197P]

Indication

4.1 Therapeutic indications

REPLAGAL is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).

Dosing

4.2 Posology and method of administration

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.

REPLAGAL home infusion, and administration by the patient in presence of a responsible adult or administration by the patient’s caregiver (self-administration), may be considered for patients who are tolerating their infusions well. The decision to have a patient move to home infusion and/or self-administration should be made after evaluation and recommendation by the treating physician.

Approriate training should be given by the treating physician and/or nurse to the patient and/or caregiver prior to initiation of self-administration. Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional. Self-administration should be closely followed by the treating physician.

Any patients experiencing adverse events during the home infusion/self-administration need to immediately stop the infusion process and seek the attention of a healthcare professional. Subsequent infusions may need to occur in a clinical setting.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.