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Association of Raptiva (efalizumab) with serious infections, including progressive multifocal leukoencephalopathy in patients with psoriasis - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

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 EMD Serono Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on Raptiva (efalizumab)

December 22, 2008

Subject: Association of RAPTIVA^® (efalizumab) with Serious Infections,
 including Progressive Multifocal Leukoencephalopathy in Patients
 with Psoriasis

EMD Serono Canada Inc., in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning RAPTIVA (efalizumab).

RAPTIVA is authorized for the treatment of psoriasis in adult patients (18 years or older).

Risk of Serious Infections, including Progressive Multifocal Leukoencephalopathy (PML)

Raptiva works by suppressing the body’s immune response to reduce psoriasis inflammation.  However, by diminishing the body's natural defense system, it can also increase the risk of serious infections in some patients. 

Infections, some serious and leading to hospitalizations or deaths, have been observed in patients treated with RAPTIVA. These infections have included the invasion of the bloodstream or other body tissues by bacteria, fungi or viruses, some of which involve the brain and/or the spinal cord. 

PML is a rare and sometimes fatal, brain disorder, caused by the reactivation of a latent virus which results in progressive damage or inflammation of the brain. The offensive virus which can be found in up to 80% of healthy adults usually stays harmless, in a dormant form in healthy individuals. PML occurs almost exclusively in people with severe immune deficiency, who as a result are rendered more susceptible to infection. There are no known interventions that can reliably prevent or adequately treat PML.

Two (2) deaths from PML have been reported in the United States in patients who were being treated with RAPTIVA for longstanding psoriasis. Both cases occurred in patients aged 70 or older who received RAPTIVA continuously for approximately 4 years. One of the affected patients had also received another medication that suppresses the immune system for a short time, 3 years prior to the diagnosis of PML. These patients were diagnosed with PML approximately 4 years after starting RAPTIVA. A direct cause and effect between RAPTIVA and these events has not been established, but cannot be ruled out.

It is estimated that approximately 46,000 patients have been treated with RAPTIVA worldwide, since it was first authorized. These two are the first confirmed cases of PML associated with RAPTIVA.

Signs and symptoms of PML may include:
Sudden change or difficulty thinking, difficulty walking, or speaking, or other behavioural changes, weakness, loss of balance or coordination, visual impairment, partial paralysis of one side of the body, or seizures.
Other serious infections may manifest as fever, weakness, cough, flu-like symptoms, warm, red or painful skin or open sores on your body.

If you develop any of the above or any other unusual signs or symptoms, please contact your doctor or healthcare professional immediately. Do not change or stop your treatment without first speaking to your doctor.

The prescribing information for RAPTIVA will be revised to include more information on serious infections including PML.

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 occurrence of serious and/or unexpected adverse reactions in patients receiving RAPTIVA should be reported to EMD Serono Canada Inc., or Health Canada at the following addresses:

Should you have any questions regarding the use of RAPTIVA, please call the EMD Serono Medical Information/Drug Safety Department at 1-888-737-6668 x5160.

original signed by

Dr. Horia Ijacu
Medical Director, Marketed Products
EMD Serono Canada