Archived - Cerezyme (imiglucerase for injection) - Supply and Recommendations for Restarting Cerezyme - For the Public

Starting date:

December 21, 2009

Posting date:

December 29, 2009

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000726

This is duplicated text of a letter from Genzyme Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - 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

Cerezyme is used to treat patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease resulting in one or more of the following conditions:

• anaemia
• low platelet count
• bone disease
• enlarged liver or spleen

As a result of an interruption in production, Genzyme Canada advised the Canadian Gaucher community on June 29, 2009 of a treatment guidance designed to conserve the supply of Cerezyme in order to protect the most vulnerable patients. This guidance was established by the international Cerezyme Stakeholders Working Group (a group of Gaucher community stakeholders including medical experts and patient advocates).

In January 2010, Genzyme Canada will begin shipping Cerezyme to all Canadian patients who have had to stop receiving their Cerezyme treatment. Genzyme will fulfill orders one infusion at a time for each patient. Healthcare providers have been informed of this and provided with recommendations for resuming treatment. Patients should contact their doctors to arrange to restart treatment in 2010. Your doctor should determine how and where to restart Cerezyme based on your present condition and how you have tolerated Cerezyme^® infusions in the past. For some patients with a history of infusion reactions, this may imply restarting Cerezyme in a hospital or clinic setting.

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:

Genzyme Canada Inc.

800-2700 Matheson Blvd. East

Mississauga, Ontario  L4W 4V9

Telephone: 1-905-625-0011

Fax: 1-905-625-7811

Any suspected adverse reaction can also be reported to:

Canada Vigilance Program

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701D

Ottawa, Ontario, K1A 0K9

Telephone: 613-957-0337 or Fax: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Telephone: 1-866-234-2345

Fax: 1-866-678-6789

CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

For any additional information, please contact Genzyme Medical Information at 1-800-745-4447 or medinfo@genzyme.com.

Sincerely,

original signed by

Brian Lewis

General Manager

Genzyme Canada Inc.