PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information
Regarding WinRho(R) SDF (Rho(D) Immune Globulin (Human))

SUBJECT: Association of WinRho(R) SDF (Rho(D) Immune Globulin (Human)) with Intravascular Hemolysis in the Treatment of Immune Thrombocytopenic Purpura (ITP)

TORONTO and WINNIPEG, March 26 /CNW/ - Cangene Corporation, in consultation with Health Canada, is informing Canadian patients and healthcare professionals of important new safety information concerning the use of WinRho(R) SDF (Rho (D) Immune Globulin (Human)) for the treatment of immune thrombocytopenic purpura, also called immune thrombocytopenia, or ITP. WinRho(R) SDF belongs to a group of biological medicines derived from human plasma known as immunoglobulins. It is administered in hospitals by infusion through the veins.

There have been rare reports of a serious side effect, called intravascular hemolysis (IVH), following WinRho(R) SDF treatment for ITP. IVH occurs when red blood cells are broken down in the blood vessels, which can cause serious illness. Symptoms of IVH can occur hours to days after WinRho(R) SDF treatment. If you experience any of the following symptoms after receiving WinRho(R) SDF, you should call your doctor immediately:

    
    -   back pain,
    -   discoloured or darkened urine,
    -   decreased urine production,
    -   jaundice (yellow colour in skin or eyes),
    -   swelling,
    -   shortness of breath.
    

Between March 1995 and March 2009 worldwide there were 180 serious case reports of suspected and/or confirmed IVH reported to the manufacturer, Cangene Corporation. Of these, 58 case reports were considered definite IVH, and, although other factors were involved, 17 of these patients died. Thirteen of the patients who died were older than 65, and 15 of them also had other medical conditions which may have made the outcome worse. In Canada, 11 cases of suspected IVH have been reported to Health Canada. Two of these patients died.

New exclusion criteria (known as contraindications) and instructions for patient monitoring have been added to the WinRho(R) SDF prescribing information. The following patients SHOULD NOT be treated with WinRho(R) SDF for ITP:

    
    -   Patients who have leukemia or lymphoma (blood cancers)
    -   Patients who have infections with Epstein-Barr virus or with
        hepatitis C
    -   Patients who are older than 65 and who have other conditions which
        make them more likely to develop hemolysis, or to develop further
        health problems resulting from hemolysis
    -   Patients who may be likely to develop hemolysis, as a result of
        diseases such as autoimmune hemolytic anemia (Evan's Syndrome),
        Systemic Lupus Erythematosus (SLE) or anti-phospholipid antibody
        syndrome (APS)
    

In addition, patients receiving WinRho(R) SDF for ITP should be monitored by their healthcare providers for 8 hours after receiving their treatment, and their urine should be tested for the presence of blood before the infusion and 2, 4 and 8 hours after the infusion.

Managing marketed health product-related adverse reactions depends on health care 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 serious cases of IVH or other serious or unexpected adverse reactions in patients receiving WinRho(R) SDF for any reason should be reported to Cangene Corporation or Health Canada:

    
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    ANY SUSPECTED ADVERSE REACTION CAN BE REPORTED VIA TELEPHONE, FAX OR
    EMAIL TO:

    Safety Surveillance Officer
    Cangene Corporation Pharmacovigilance Unit
    155 Innovation Drive
    Winnipeg, MB R3T 5Y3
    Tel: [phone]
    Fax: [phone]
    Cell: 204-295-2935 (24 hour access)
    Toll free number (for USA and Canada) 800-768-2304 (24 hour access)
    E-mail: [email protected]

    Canada Vigilance Program
    Marketed Health Products Directorate
    HEALTH CANADA
    Address Locator 0701C
    Ottawa, ON K1A 0K9
    Tel: [phone] or Fax: [phone]
    To report an Adverse Reaction, consumers and Health Professionals may
    call toll free:
    Tel: [phone]
    Fax: [phone]
    [email protected]

    The AR Reporting Form and the AR Guidelines can be found on the Health
    Canada website or in The Canadian Compendium of Pharmaceuticals and
    Specialties
    

http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_e.html

http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guide-ldir_e.html

    
    FOR OTHER INQUIRIES, PLEASE CONTACT HEALTH CANADA AT:

    Marketed Health Products Directorate (MHPD)
    [email protected]
    Tel: [phone]
    Fax: [phone]
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    Sincerely,

    original signed by

    Maurice Généreux M.D.
    Medical Director
    Cangene Corporation
    

For further information: Should you have any questions regarding the use of WinRho(R) SDF, please contact Cangene Medical Affairs/Pharmacovigilance at 1-800-768-2304 (toll-free) or via email at [email protected] or [email protected]