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Title: Efalizumab Associated With Serious Infections, Progressive Multifocal Leukoencephalopathy

"Efalizumab Associated With Serious Infections, Progressive Multifocal Leukoencephalopathy"

OTTAWA, Ontario -- December 31, 2008 -- EMD Serono Canada Inc., in collaboration with Health Canada, is informing healthcare professions of important new safety information regarding the risk of serious infections, including progressive multifocal leukoencephalopathy (PML), in patients receiving efalizumab (Raptiva). Efalizumab has the potential to increase the risk of infection and/or reactivate latent, or chronic infections. During post-market experience, serious bacterial, viral, fungal and opportunistic infections have been reported. Some of these infections have been fatal. Two cases of fatal PML have been reported in the US in association with the use of efalizumab for the treatment of plaque psoriasis. Both cases occurred in patients aged 70 years or older, who received efalizumab continuously for approximately 4 years. Physicians treating patients with efalizumab should consider PML in any patient who presents with new onset neurologic manifestations. Efalizumab should be permanently discontinued in patients who develop PML, and appropriate treatment should be instituted. Infections, some serious and leading to hospitalisations or deaths, have been observed in patients treated with efalizumab. These infections have included bacterial sepsis, viral meningitis, shingles, invasive fungal disease, John Cunningham (JC) virus infection leading to PML, and other opportunistic infections. 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 2 reports in the US of JC virus infection with resultant PML and death in patients who had been treated with efalizumab for plaque psoriasis. Both of these patients had longstanding psoriasis and 1 of them had received a total of 2 short courses of another immunosuppressive drug, before and during efalizumab therapy. Both these patients were diagnosed with PML approximately 4 years after continuous treatment with efalizumab. 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 efalizumab 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 efalizumab for longer than 3 years. However, a final diagnosis was not made and PML was not confirmed in that patient. The Canadian Product Monograph will be updated to include a boxed warning on the risk of serious infections, including PML in patients receiving efalizumab. 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 efalizumab. If a patient develops a serious infection, efalizumab should be discontinued and appropriate therapy instituted. Consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated. Worsening of psoriasis can occur upon discontinuation of efalizumab. Following discontinuation, patients should be closely monitored and appropriate psoriasis treatment instituted as necessary. 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: EMD Serono Canada Inc., 2695 North Sheridan Way, Suite 200 Mississauga ON L5K 2N6 Tel: 1-888-737-6668 ext. 5160 Fax: 905-919-0292 E-mail: drugsafetycanada@merckserono.net HEALTH CANADA Canada Vigilance Program Address Locator: 0701C Ottawa, Ontario, K1A 0K9 Telephone: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Telephone: 866-234-2345 Fax: 866-678-6789 CanadaVigilance@hc-sc.gc.ca SOURCE: Health Canada

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