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Cerezyme (imiglucerase for injection) - Supply and Recommendations for Restarting Cerezyme - For Health Professionals

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Contact: Marketed Health Products Directorate (MHPD)

Health Canada Endorsed Important Safety Information on Cerezyme (imiglucerase for injection)

December 21, 2009

Subject: Cerezyme^® (imiglucerase for injection) Supply and Recommendations for Restarting Cerezyme

Dear Health Care Professional,

In January 2010 Genzyme Canada expects to begin shipping Cerezyme to all patients who have experienced treatment interruptions. It is recommended to order as single infusions of the pre-shortage dose. Short delays in order fulfillment may occur in the first three months of 2010. This plan is based upon the best available current projections for the production and release of Cerezyme and may be subject to change, as with any plan involving biological protein therapeutics.

The U.S. Cerezyme Stakeholders Working Group (CSWG) has developed a treatment guidance to provide recommendations for restarting Cerezyme in a manner that is as safe and as simple as possible. The full guidance can be viewed on the  National Gaucher Foundation's Web site and the general recommendations contained therein are outlined as follows.

Because Gaucher disease is a highly heterogeneous and multi-systemic disorder, patients should be evaluated by their physician prior to restarting Cerezyme in order to establish their current clinical status and guide clinical decisions. All appropriate clinical, laboratory and radiologic evaluations should be considered. Recommendations for evaluation and monitoring have been previously published by international experts in Gaucher disease (Semin Hematol. 2004 October; 41(4 Suppl 5):15 - 22; Eur J Pediatr. 2004 February; 163(2):58 - 66).

Dose

Any adjustments in dose should be made based on the treating physician's clinical assessment of each patient prior to restarting treatment, and according to the approved Product Monograph.

Short-term adjustments which increase the dosing interval might also be considered, especially for those patients whose Cerezyme infusions were less than 2 weeks apart prior to the shortage period.

Infusion Rate

Any adjustments in infusion rate should be made based on the treating physician's clinical assessment of each patient prior to restarting treatment, and in accordance with the Product Monograph for Cerezyme which notes that "Cerezyme^® (imiglucerase for injection) is administered by intravenous infusion over 1-2 hours."

For patients with a history of infusion-associated reactions (pruritus, flushing, rash, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension), physicians may decide to begin the infusion at a slower rate and gradually increase the rate during the infusion, as tolerated. Cerezyme infusions should be supervised by an appropriately trained person throughout the duration of the infusion.

Site of Service

In general, patients with no recent history of infusion-associated reactions may resume Cerezyme infusions at their previous site of service. Patients who resume infusions at home should be supervised by an appropriately trained person throughout the duration of the Cerezyme infusion in accordance with the approved Product Monograph.

In general, for patients with a history of severe or recent infusion-associated reactions, re-starting Cerezyme in a hospital or clinic setting should be considered.

For the remainder of 2009, uninterrupted treatment for the most vulnerable patients (those currently receiving Cerezyme) will continue. This group includes children ≤ 18 years old, patients with type 3 disease and adults who are receiving treatment through the Canadian Cerezyme Emergency Access Program (CEAP).

The CEAP will remain open for new (treatment-naïve) patients who meet the CEAP criteria. Genzyme Canada will notify the Canadian Gaucher community when the Cerezyme supply becomes adequate for other new patients to begin treatment.

Clinical data collected during the period of Cerezyme shortage may yield important medical information on the effects of dose reduction and treatment interruption. Physicians who have previously enrolled their patients in the ICGG Gaucher Registry should collect data from these patients and enter those data into the Registry. The combined data from many patients may provide valuable answers to these important unanswered questions about dose reduction and treatment interruption.

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious reactions related to restarting infusions of CEREZYME or other serious or unexpected adverse reactions in patients receiving CEREZYME should be reported to Genzyme Canada Inc. or Health Canada at the following addresses:

This letter is posted on the Health Canada Web site, as well as the  Genzyme Canada Inc. Web site.

For more information or to discuss any concerns, please contact your local Genzyme representative or Genzyme Medical Information at 1-800-745-4447 or medinfo@genzyme.com. Once again, we greatly appreciate your understanding and dedication to helping the Gaucher community through this challenging period.

Sincerely,

original signed by

Brian Lewis
General Manager
Genzyme Canada Inc.