WinRho SDF (Rho(D) Immune Globulin (Human)) - Association with Intravascular Hemolysis in the Treatment of Immune Thrombocytopenic Purpura (ITP) - Important New Prescribing Information - Notice to Hospitals

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

Notice to Hospitals
Health Canada Endorsed Important Safety Information on WinRho SDF (Rho(D) Immune Globulin (Human))

March 22, 2010

To: Hospital Chief of Medical Staff

Please distribute to the Blood Bank and the relevant Departments of Hematology and Internal Medicine as well as other involved professional staff and POST THIS NOTICE IN YOUR INSTITUTION.

Subject: Association of WinRho^® SDF (Rho(D) Immune Globulin (Human)) with Intravascular Hemolysis in the Treatment of Immune Thrombocytopenic Purpura (ITP) -Important New Prescribing Information

Cangene Corporation, in consultation with Health Canada, wishes to inform healthcare professionals of changes to the prescribing information, including new contraindications and conditions for use, for the treatment of ITP with WinRho^® SDF.

In post-marketing surveillance of WinRho^® SDF from March 1995 to March 2009 Cangene Corporation reported a total of 180 serious case reports of suspected and/or confirmed cases of IVH worldwide. Of the 180 serious case reports, 58 were considered definite IVH, 59 were probable IVH and 47 were possible IVH. Seventeen of the 58 definite IVH cases reported fatal outcome. Thirteen of the patients with fatal outcome were over 65 years of age and in 15 out of those 17 fatal cases, the patients had a history of serious underlying co-morbid diseases that are considered to have induced or exacerbated pathological conditions leading to fatal outcomes. Eleven reports of suspected WinRho^® SDF - related hemolytic reaction have been received by Health Canada. Of these, two had a fatal outcome.

A disproportionate number of IVH cases have been reported in patients with ITP secondary to hematological malignancies such as leukemia or lymphoma, or active viral infections with HCV and EBV. Elderly patients (over 65 years) with co-morbidities are more likely to experience complications from hemolysis, including fatal outcomes. WinRho^® SDF should not be used to treat ITP in these patients.

Physicians are advised that if a patient has evidence of hemolysis (reticulocytosis greater than 3%) prior to ITP treatment, or is at high risk for hemolysis (positive DAT not attributed to previous immune globulin administration), alternate therapies must be used.

Patients should be kept under observation in a health care setting for a period of 8 hours after receiving WinRho^® SDF for the treatment of ITP. Absence of signs and/or symptoms of IVH within eight hours does not indicate that IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho^® SDF administration, post treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect). Physicians should discuss the risks and benefits of WinRho^® SDF and alert patients who are being treated for ITP about the signs and/or symptoms of IVH.

These changes do not apply to patients receiving WinRho^® SDF for the prevention of Rh immunization. Healthcare professionals are reminded to consult the Canadian Product Monograph for full prescribing information.

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 indication should be reported to Cangene Corporation or Health Canada:

Cangene Corporation is committed to providing updated information to healthcare professionals to ensure WinRho^® SDF is used safely and effectively. Should you have any questions regarding the use of WinRho^® SDF, please contact Cangene Medical Affairs at 1-800-768-2304.

original signed by

Maurice Généreux M.D.
Medical Director
Cangene Corporation