Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Supply shortage of Cerezyme more severe than expected

The supply shortage of Genzyme’s Cerezyme (imiglucerase), reported by the European Medicines Agency (EMEA) earlier this year (PJ Online, 10 July 2009), is more severe than previously thought

The supply shortage of Genzyme’s Cerezyme (imiglucerase), reported by the European Medicines Agency (EMEA) earlier this year, is more severe than previously thought.

The agency’s Committee for Medicinal Products for Human Use has agreed new temporary treatment recommendations: only patients at greatest need of treatment — infants, children and adolescents, and adults with severe, life-threatening progression of Gaucher’s disease — will receive Cerezyme, and then at a reduced dose, until the supply situation is resolved (see Panel below).

Genzyme is sending information to all Cerezyme prescribers on how to select patients for dose reduction, switch to alternative treatment or suspend treatment. The company has also said that the stock-sparing measures will have no impact on supplies to ongoing clinical trials.

The shortage has been caused by the shutting down of the production site for Cerezyme and Fabrazyme (agalsidase beta) in the US because of viral contamination.

The production site bioreactors have been cleaned and manufacture of both medicines has resumed. However, Genzyme has informed the EMEA that the existing stocks of Cerezyme are lower than previously reported.

The EMEA expects the temporary recommendations to continue until the end of 2009. The temporary treatment recommendations for Fabrazyme issued in June 2009 remain unchanged.

Updated recommendations during the supply shortage

  • Infants, children and adolescents should receive Cerezyme at a reduceddose or at a reduced infusion frequency. However, no patient should betreated at a dose lower than 15 U/kg body weight every two weeks, oralternative treatment should be considered.
  • Adults with severe, life-threatening disease progression shouldreceive Cerezyme at a reduced dose or at a reduced infusion frequency.No patient should be treated at a dose lower than 15 U/kg every fourweeks, or alternative treatment should be considered.
  • In adults without severe, life-threatening disease, alternativetreatment, such as miglustat, should be considered or treatment shouldbe interrupted.
  • Adults who demonstrate progression to severe, life-threateningdisease should restart the original treatment with Cerezyme.
  • All patients should be monitored for changes in haemoglobin,platelets and chitotriosidase levels, as appropriate, at baseline andtwice a month thereafter.

Citation: The Pharmaceutical Journal URI: 10975871

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Strategic Medicines Management

    Strategic Medicines Management

    A practical guide to influencing the availability of medicines, and policies of their use. Focuses on the strategic elements of medicines management.

    £33.00Buy now
  • Introduction to Clinical Pharmaceutics (An)

    Introduction to Clinical Pharmaceutics (An)

    This unique textbook covers the role of basic pharmaceutics in clinical outcomes and in explaining the behaviour of medicines in the body.

    £27.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.