Print | Need Larger Text? | Share

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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 43 K)

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.

Health Canada Endorsed Important Safety Information on Raptiva (efalizumab)

December 22, 2008

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

Dear Health Care Professional,

EMD Serono Canada Inc., in collaboration with Health Canada, would like to inform you of important new safety information regarding the risk of serious infections, including progressive multifocal leukoencephalopathy (PML), in patients receiving RAPTIVA^® (efalizumab).

RAPTIVA is an immunomodulating, humanized monoclonal antibody and is currently authorized for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is estimated that approximately 46,000 patients have been administered RAPTIVA worldwide, since this drug was first authorized.

Infections, some serious and leading to hospitalizations or deaths, have been observed in patients treated with RAPTIVA. These infections have included bacterial sepsis, viral meningitis, shingles, invasive fungal disease, John Cunningham (JC) virus infection leading to PML, and other opportunistic infections. 

PML is a rare, progressive, demyelinating disease of the central nervous system that can lead to death or severe disability. PML is caused by reactivation of the (JC) virus, which usually resides and stays dormant in latent form in up to 80% of healthy adults. The JC virus typically only causes PML in immune compromised patients. The factors leading to activation of the latent infection are not fully understood, although abnormalities in T cells have been described as important for viral reactivation.

There have been reported cases of PML associated with other systemic therapies used for psoriasis, although the affected patients were being treated for conditions other than psoriasis. PML has also been observed in HIV positive patients, immune suppressed cancer patients, transplantation patients and patients with autoimmune diseases.

There have been two reports in the United States, of JC virus infection with resultant PML and death in patients who had been treated with RAPTIVA for plaque psoriasis. Both of these patients had longstanding psoriasis and one of them had received a total of two short courses of another immunosuppressive drug, before and during RAPTIVA therapy. Both these patients were diagnosed with PML approximately 4 years after continuous treatment with RAPTIVA.  In both cases, PML was diagnosed based on the detection of JC viral DNA in the cerebro-spinal fluid, clinical symptoms, and magnetic resonance imaging (MRI) findings. There are no other cases of confirmed PML in RAPTIVA treated patients in the worldwide safety database.

EMD Serono Canada was also informed of a fatal case of suspected PML in a patient with chronic plaque psoriasis who developed progressive degenerative neurologic symptoms, after being treated with RAPTIVA for longer than 3 years. However, a final diagnosis was not made and PML was not confirmed in that patient.

There are no known interventions that can reliably prevent or adequately treat PML.

As a result:

• The Canadian Product Monograph will be updated to include a boxed warning on the risk of serious infections, including PML in patients receiving RAPTIVA. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of serious infection during and after treatment with RAPTIVA. If a patient develops a serious infection, RAPTIVA should be discontinued and appropriate therapy instituted.
  
  
• Physicians should consider PML in any patient being treated with RAPTIVA who presents with new onset neurologic manifestations. In patients who develop PML, RAPTIVA should be permanently discontinued and appropriate treatment should be instituted. Consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
  
  
• Worsening of psoriasis can occur upon discontinuation of RAPTIVA. Following discontinuation, patients should be closely monitored and appropriate psoriasis treatment instituted as necessary. 

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