Dear Healthcare Provider Letter - Avastin (May 2013)

Roche

Subject: Direct Healthcare Professional Communication on Cases of Necrotising Fasciitis
Reported with Avastin®
15th May 2013

Dear Healthcare Provider,

Roche Products Ltd. would like to inform you of the following safety information regarding the use of Avastin® (bevacizumab):

Summary
 Necrotising fasciitis, including fatal cases, has been reported in patients receiving Avastin in both clinical trials and in the post-marketing setting.
 It is recommended that Avastin is discontinued and appropriate therapy initiated promptly upon diagnosis of necrotising fasciitis.
The information in this letter has been agreed with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA).

Further information on the safety concern
Necrotising fasciitis is a rare but life-threatening infection of the soft tissue, characterized by rapidly spreading necrosis of superficial fascia and subcutaneous tissue. Immuno-compromised patients are at a higher risk of developing necrotising fasciitis.
The reported cases of necrotising fasciitis in Roche clinical trials and global safety database occurred in patients with several different types of cancer. Regarding associated medical conditions, the majority of the patients had gastrointestinal perforation, fistula formation or wound healing complications preceding the development of necrotising fasciitis. Some of these patients died due to complications of necrotising fasciitis.....