WinRho SDF (Rh_o(D) Immune Globulin (Human)) - Association with Intravascular Hemolysis in the Treatment of Immune Thrombocytopenic Purpura (ITP) - Important New Prescribing Information - For the Public

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Contact: Marketed Health Products Directorate

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.

This is duplicated text of a letter from Cangene Corporation.
Contact the company for a copy of any references, attachments or enclosures.

public communication
Health Canada Endorsed Important Safety Information on WinRho SDF (Rh_o (D) Immune Globulin (Human))

March 22, 2010

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 consultation with Health Canada, is informing Canadian patients and healthcare professionals of important new safety information concerning the use of WinRho^® SDF (Rh_o(D) Immune Globulin (Human)) for the treatment of immune thrombocytopenic purpura, also called immune thrombocytopenia, or ITP. WinRho^® 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^® 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^® SDF treatment. If you experience any of the following symptoms after receiving WinRho^® 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^® SDF prescribing information. The following patients should not be treated with WinRho^® 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^® 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^® SDF for any reason should be reported to Cangene Corporation or Health Canada:

Safety Surveillance Officer
Cangene Corporation Pharmacovigilance Unit
155 Innovation Drive
Winnipeg, MB R3T 5Y3
Telephone: 204-275-4509
Fax: 204-275-4330
Cellular: 204-295-2935 (24 hour access)
Toll free number (for USA and Canada) 1-800-768-2304 (24 hour access)
E-mail: pharmacovigilance@cangene.com

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
CanadaVigilance@hc-sc.gc.ca

To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789

Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Should you have any questions regarding the use of WinRho^® SDF, please contact Cangene Medical Affairs/Pharmacovigilance at 1-800-768-2304 (toll-free) or via email at pharmacovigilance@cangene.com or medicalaffairs@cangene.com.

Sincerely,

original signed by

Maurice Généreux M.D.
Medical Director
Cangene Corporation