CEREZYME
IMIGLUCERASE · by SANOFI-AVENTIS
Composition
Inf: Each vial contains Imiglucerase 400 unit powder for reconstitution for infusion
Indications & Dosage
Non-neurological manifestations of type I and type III Gauchers disease (specialist use only): BY IV INF: Adult: Initially 60 units/kg every 2 weeks; maintenance dose to be adjusted according to response, 15 units/kg once every 2 weeks may improve haematological parameters and organomegaly.
Administration
For IV infusion give intermittently in Sodium chloride 0.9%; initially reconstitute with water for injections (400 units in 10.2 ml) to give 40 units/ml solution; dilute requisite dose with infusion fluid to a final volume of 100–200 ml and give initial dose at a rate not exceeding 0.5 units/kg/minute, subsequent doses to be given at a rate not exceeding 1 unit/kg/minute; administer within 3 hours after reconstitution.
Contraindications
Life threatening hypersensitivity (anaphylactic reaction) to the substance
Precautions
Monitor for immunoglobulin G (IgG) antibodies to imiglucerase. Whenstabilised,monitorallparametersandresponseto treatment at intervals of 6–12 months.
Pregnancy
Use with caution, treatment should not be withheld
Lactation
Avoid breast feeding during treatment
Side Effects
Abdominal cramps, angioedema, cough, dyspnoea, hypersensitivity, skin reactions, arthralgia, back pain, chest discomfort, chills, cyanosis, diarrhoea, dizziness, fatigue, fever, flushing, headache, hypotension, nausea, paraesthesia, tachycardia, vomiting