- Approval Id
- 7596325ef4f1dba5
- Drug Name
- REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML
- Product Name
- REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML
- Approval Number
- SIN16197P
- Approval Date
- 2021-05-17
- Registrant
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Licence Holder
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- **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.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **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).
- 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_.
- Atc Code
- A16AB03
- Atc Item Name
- agalsidase alfa
- Pharma Manufacturer Name
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Company Detail Path
- /organization/cb7f295348c72082/takeda-pharmaceuticals-asia-pacific-pte-ltd
