Cerezyme Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Imiglucerase

Indications/Uses

Long-term enzyme replacement therapy in patients w/ confirmed diagnosis of non-neuronopathic (type 1) or chronic neuronopathic (type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease which include ≥1 of the following conditions: anaemia after exclusion of other causes eg, Fe deficiency; thrombocytopenia; bone disease after exclusion of other causes eg, vit D deficiency; hepatomegaly or splenomegaly.

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Dosage/Direction for Use

IV At initial infusions, administer at a rate not exceeding 0.5 U/kg/min. At subsequent infusions, rate may be increased but should not exceed 1 U/kg/min. Individualise dose based on comprehensive evaluation of all clinical manifestations of the disease. Initial doses of 60 U/kg once every 2 wk have shown improvement in haematological & visceral parameters w/in 6 mth of therapy & continued use has either stopped progression of or improved bone disease. Administration of doses as low as 15 U/kg once every 2 wk has been shown to improve haematological parameters & organomegaly, but not bone parameters.

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Overdosage

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Contraindications

Hypersensitivity.

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Special Precautions

Periodically monitor for IgG Ab formation in patients suspected of decreased response to treatment. Higher risk of hypersensitivity reactions in patients w/ Ab to imiglucerase. Immediately discontinue infusion if severe allergic-type hypersensitivity reactions occur. Caution in patients who have developed Abs or symptoms of hypersensitivity to alglucerase. Contains 41 mg Na per vial & administered in 0.9% NaCl IV soln; to be taken into consideration by patients on controlled Na diet. Assess risk & benefit of treatment in pregnant Gaucher patients & those intending to become pregnant. Treatment-naïve women should consider commencing therapy prior to conception. Women receiving Cerezyme should consider continuation of treatment throughout pregnancy. Not known whether imiglucerase is excreted in human milk, however, it is likely to be digested in the child's GIT. Efficacy on neurological symptoms of chronic neuronopathic Gaucher patients has not been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dyspnoea, coughing; hypersensitivity reactions; urticaria/angioedema, pruritus, rash.

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Caution For Usage

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Storage

View Cerezyme storage conditions for details to ensure optimal shelf-life.

Description

View Cerezyme description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Other Agents Affecting Metabolism

ATC Classification

A16AB02 - imiglucerase ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Cerezyme powd for conc for soln for infusion (vial) 400 U

Packing/Price

1's

Cerezyme

imiglucerase

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare