Letter from Roche to health care professionals dated December 16, 2008. Related to off- label uses in ophtalmology of bevacizumab (Avastin):
Reports of Eye Inflammation, Endophthalmitis, and Toxic Anterior Segment Syndrome (TASS) Following Off-label Intravitreal Use of AVASTIN® (bevacizumab)
Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of important new safety information regarding off-label intravitreal use of AVASTIN (bevacizumab).
AVASTIN is a recombinant humanized monoclonal antibody that is directed against the vascular endothelial growth factor (VEGF). It is authorized for intravenous administration in the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine based cancer chemotherapy.
Use of AVASTIN in the ophthalmology setting has neither been reviewed nor authorized by Health Canada.
As of November 26, 2008, Roche has been made aware of 25 spontaneously reported Canadian cases of eye inflammation, endophthalmitis, blurred vision, and floaters, some of which have been described as Toxic Anterior Segment Syndrome (TASS), in patients who were administered aliquots of AVASTIN Lot B3002B028 intravitreally. This is currently the subject of further investigations. All analytical release data has been reviewed by Roche for this manufactured lot and all test parameters were well within limits established for the authorized use of AVASTIN.
A review of adverse event reports received in 2008 does not indicate any unusual reporting pattern associated with this lot or any other particular lot of AVASTIN distributed in Canada when used for the authorized indication.
TASS is a sterile postoperative inflammatory reaction caused by a non-infectious substance that enters the anterior segment of the eye and results in toxic damage to intraocular tissues1.
Roche has neither studied nor sought authorization for the use of Avastin in the ophthalmology setting. The current production methods, formulation and dosages for AVASTIN were developed specifically for intravenous use in the oncology setting.
Source: Reports of Eye Inflammation, Endophthalmitis, and Toxic Anterior Segment Syndrome (TASS) Following Off-label Intravitreal Use of Avastin (bevacizumab) – For Health Professionals. Health Canada
Comments are closed.