RITUXAN (rituximab) - Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome - For Health Professionals

Starting date:
February 20, 2013
Posting date:
February 25, 2013
Type of communication:
Dear Healthcare Professional Letter
Source of recall:
Health Canada
New safety information
Healthcare Professionals
Identification number:

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)

February 20, 2013

Dear Health Care Professional:

Subject: Association of RITUXAN® (rituximab) with Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS)

Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important new safety information associated with RITUXAN.

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

  • Cases of Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been very rarely reported in the post-marketing setting, in patients who have used RITUXAN for the treatment of haematological malignancies and autoimmune disorders.
  • Some of the cases of Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) have been fatal.
  • In case of the occurrence of severe skin reactions, RITUXAN treatment should be discontinued. The decision to re-administer RITUXAN must be carefully assessed based on the individual patient’s benefit–risk profile.

Further Information

Cases of Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome have been reported to occur very rarely (2/100,000), in patients with haematological malignancies and autoimmune disorders, with first time use or with subsequent infusions. Four of the cases had a close temporal association to RITUXAN treatment occurring on, or the day following dosing. One of the cases had a fatal outcome.

In several of the cases in patients with autoimmune disorders, other treatments known to be possibly associated with Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome were administered concomitantly with RITUXAN therapy.

In patients with haematological malignancies, information on severe bullous skin reactions including fatal cases of Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome is already included in the RITUXAN Product Monograph. Based on the new safety information in autoimmune indications, Roche will be working with Health Canada to implement appropriate revisions to the Product Monograph.

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 Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome 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 MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 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