MYOZYME® (ALGLUCOSIDASE ALFA) 50MG POWDER FOR SOLUTION FOR INFUSION [SIN13543P]

Product Info

MYOZYME® (ALGLUCOSIDASE ALFA) 50MG POWDER FOR SOLUTION FOR INFUSION

[SIN13543P]

Therapeutic indications
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).
Myozyme is indicated in adults and paediatric patients of all ages.

Posology and method of administration
Myozyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases.
Posology
The recommended dose regimen of alglucosidase alfa is 20 mg/kg body weight administered once every 2 weeks.
Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease.
Paediatric and older people
There is no evidence for special considerations when Myozyme is administered to paediatric patients of all ages or older people.
Patients with renal and hepatic impairment
The safety and efficacy of Myozyme in patients with renal or hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients.

Method of administration
Myozyme should be administered as an intravenous infusion.
Infusions should be administered incrementally. It is recommended that the infusion begin at an initial rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30 minutes if there are no signs of infusion associated reactions (IARs) until a maximum rate of 7 mg/kg/h is reached. IARs are described in section Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
For instructions on reconstitution and dilution of the medicinal product before administration, see section Special precautions for disposal and other handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients, when rechallenge was unsuccessful (see sections Special warnings and precautions for use and Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).