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RITUXAN (rituximab) - Hepatitis B Virus (HBV) Recurrence in Patients: Updates on Screening and Management - For Health Professionals

Starting date:
July 29, 2013
Posting date:
July 29, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-34765

This is duplicated text of a letter from Hoffmann-La Roche Limited. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on RITUXAN® (rituximab)

July 29, 2013

Dear Health Care Professional:

Subject: Hepatitis B Virus (HBV) Reactivation in Patients Treated with RITUXAN® (rituximab): Updates on Screening and Management

Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important updates to the recommendations for screening and management of hepatitis B virus reactivation in patients treated with RITUXAN.

RITUXAN is an anti-CD20 monoclonal antibody indicated in the treatment of Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

  • Use of RITUXAN has been shown to be associated with reactivation of hepatitis B virus in seropositive patients.
  • It is advised that all patients be screened for hepatitis B virus (HBV) before initiation of treatment with RITUXAN.
  • RITUXAN is not to be used in patients with active hepatitis B viral disease.
  • Prior to starting treatment in HBV seropositive patients, consultation with a liver disease expert is recommended to determine ongoing monitoring of HBV reactivation and its management.

Further Information

The use of RITUXAN has been associated with HBV reactivation in patients with positive HBV surface antigen (HBsAg+ve) and in those with negative HBV surface antigen plus positive anti-HB core antibody (HBsAg-ve/HBcAb+ve), particularly when administered in combination with steroids or chemotherapy.

The existing information on hepatitis B virus reactivation in the current Product Monograph for RITUXAN is being updated to reflect the new recommendations for screening, monitoring and management of the disease.

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 case of hepatitis B reactivation or other serious or unexpected adverse reactions in patients receiving RITUXAN should be reported to Roche or Health Canada.

Hoffmann-La Roche Limited
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or fax at: 905-542-5864
or email to: mississauga.drug_safety@roche.com

To correct your mailing address or fax number, contact Hoffmann-La Roche Limited.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffectTM Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

For other health product inquires related to this communication, 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 or require additional information regarding the use of RITUXAN, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388, Monday to Friday, between 8:30 a.m. and 4:30 p.m. (Eastern Standard Time).

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited