Active Ingredient: Imiglucerase
Imiglucerase is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.
The non-neurological manifestations of Gaucher disease include one or more of the following conditions:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
15 - 60 [iU] per kg of body weight
From 15 To 60 [iU] per kg of body weight once every 14 day(s)
60 [iU] per kg of body weight
Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of all clinical manifestations of the disease. Once individual patient response for all relevant clinical manifestations is well- established, dosages and frequency of administration may be adjusted with the goal to either maintain already reached optimal parameters for all clinical manifestations or further improve those clinical parameters which have not yet been normalised.
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease. Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy and continued use has either stopped progression of or improved bone disease. Administration of doses as low as 15 U/kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters. The usual frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
After reconstitution and dilution, the preparation is administered by intravenous infusion. At initial infusions, imiglucerase should be administered at a rate not exceeding 0.5 unit per kg body weight per minute. At subsequent administrations, infusion rate may be increased but should not exceed 1 unit per kg body weight per minute.
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