About Tysabri? (natalizumab)

About Tysabri?

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In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program.

In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS.

Serious adverse events that occurred in MS patients treated with TYSABRI included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the rate of other serious and non-serious adverse events, including the overall rate of infections, was balanced between treatment groups. Herpes infections were slightly more common in MS patients treated with TYSABRI. The most common adverse reactions (incidence = 10%) in MS patients were headache, fatigue, arthralgia, urinary infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, and rash.

Serious adverse events that occurred in CD patients receiving TYSABRI included intestinal obstruction, hypersensitivity reactions, abscesses, gastroenteritis, intestinal adhesions and gallstones. In CD trials, the rate of infections was slightly higher in patients treated with TYSABRI than those receiving placebo. However, the incidence of serious infections was comparable between groups. Serious opportunistic and other atypical infections have been uncommonly observed in patients treated with TYSABRI, more so in CD patients than those suffering from MS. Some of these patients were receiving concurrent immunosuppressants. One of the 3 previously reported cases of PML was seen in a CD patient. The most common adverse reactions (incidence = 10%) in CD patients were headache, upper respiratory tract infection, nausea, and fatigue.

For more information about TYSABRI please visit http://www.tysabri.com∞, http://www.biogenidec.com∞ or http://www.elan.com∞, or call 1-800-456-2255
http://www.medilexicon.com/medicalnews.php?newsid=59906∞

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