For the Public - Association of WinRho SDF [Rho(D) Immune Globulin (Human)] with Intravascular Hemolysis in the treatment of Immune Thrombocytopenic Purpura

Starting date:

January 24, 2006

Posting date:

January 26, 2006

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000481

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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Contact : MHPD DPSC

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on WinRho^® SDF (Rh_o (D) Immune Globulin (Human))

January 24, 2006

Subject: Association of WinRho^® SDF (Rh_o (D) Immune Globulin (Human)) with Intravascular Hemolysis in the treatment of Immune Thrombocytopenic Purpura (ITP)

Cangene Corporation, in collaboration with Health Canada, is informing healthcare professionals in Canadian hospitals of important new safety information concerning WinRho^® SDF (Rh_o (D) Immune Globulin (Human)).

WinRho^® SDF belongs to a group of biological medicines derived from human plasma known as immunoglobulins. Immunoglobulins are used to treat patients with Idiopathic Thrombocytopenic Purpura (ITP). It is administered in hospitals by infusion through the veins.

• Among patients treated with WinRho^® SDF for ITP there have been rare reports of a potentially serious reaction called Intravascular Hemolysis in which red blood cells are broken down in the blood vessels.
• Potentially serious complications of intravascular hemolysis, including significant reductions in the number of red blood cells, impaired kidney function and clotting inside the blood vessels, leading in some cases to death, have been reported rarely in patients receiving WinRho^® SDF

Symptoms of intravascular hemolysis and its complications can vary in severity with most occurring within hours, but in some cases days, of administration. The symptoms may include:

• generalized weakness
• lightheadedness
• back pain
• discoloured urine or darkened urine
• jaundice
• decreased urine production
• swelling
• sudden weight gain
• shortness of breath

Should a patient be experiencing any of these symptoms following treatment with WinRho^® SDF, consult your specialist immediately to confirm the diagnosis and determine if any treatment is necessary.

Pharmacovigilance Unit

Cangene Corporation

26 Henlow Bay

Winnipeg, Manitoba

Canada R3Y IG4

Tel: 1-800-768-2304

Fax: 1-800-768-2281

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

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

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR 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

Tel: (613) 954-6522

Fax: (613) 952-7738

Should you have any questions regarding the use of WinRho^® SDF, please contact Cangene Medical Affairs at 1-204-275-4368.

Sincerely,

original signed by

Maurice Généreux M.D.

Medical Director

Cangene Corporation