Archived - Important Safety Information on RITUXAN (rituximab) - Hoffmann-La Roche Limited - For the Public

Starting date:

August 8, 2007

Posting date:

August 13, 2007

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000596

This is duplicated text of a letter from Hoffmann-La Roche Ltd.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication

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

August 8, 2007

Subject: Association of RITUXAN^® (rituximab) with Progressive Multifocal Leukoencephalopathy (PML) in patients with Systemic Lupus Erythematosus (SLE) and vasculitis

Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning RITUXAN (rituximab).

RITUXAN is authorized in Canada for the treatment of non-Hodgkin's lymphoma (a cancer of the lymph nodes) and rheumatoid arthritis (an inflammatory disease of the joints).

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare and sometimes fatal disorder, caused by a virus which causes progressive damage or inflammation of the brain. It occurs almost exclusively in people with severe immune deficiency, who are more susceptible to disease.

Two (2) deaths from PML have been reported in patients with SLE treated with RITUXAN. Both of these patients had longstanding SLE and were given multiple courses of medications that suppress the immune system (the body's system of defenses against disease) before receiving RITUXAN. One (1) case was also reported in a patient with vasculitis (inflammation of the blood vessels) treated with RITUXAN. This patient received multiple courses of medications that suppress the immune system before and during RITUXAN treatment. All cases occurred within 12 months of the last RITUXAN infusion and none of them occurred in Canada. A direct cause and effect between RITUXAN and these events has not been established, but cannot be ruled out.

PML has also been reported in patients with SLE or vasculitis receiving other medications that suppress the immune system without being given RITUXAN at the same time. Very rare cases (less than one case per 10,000 treated patients) have also been seen in patients with lymphoma receiving RITUXAN, although most of them were also receiving other medications that suppress the immune system.

In Canada, RITUXAN is not authorized for use in the treatment of patients with autoimmune diseases other than rheumatoid arthritis.

Hoffmann-La Roche Limited has sent a letter to healthcare professionals informing them of this new safety information. A copy of the healthcare professional letter and this communication are available on the Health Canada Website.

The prescribing information for RITUXAN has been revised to include more information on the cases of PML with RITUXAN.

Some examples of signs and symptoms of PML are:

• memory loss
• difficulty thinking, confusion
• loss of vision
• difficulty walking or speaking
• seizures
• loss of balance or coordination.

If you develop any of the above or any other unusual signs or symptoms, please contact your doctor or healthcare professional immediately.

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 or unexpected adverse reactions in patients receiving RITUXAN should be reported to Hoffmann-La Roche Limited, or Health Canada at the following addresses:

Hoffmann-La Roche Limited

Drug Safety Department

2455 Meadowpine Boulevard

Mississauga, ON 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

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

Sincerely,

Original signed by

Lorenzo Biondi

Vice President, Medical and Regulatory Affairs

Hoffmann-La Roche Limited