Genentech is warning healthcare providers of 36 reports of intraocular adverse events following the off-label intravitreal use of Avastin (bevacizumab) injection. Twenty five of these events occurred in patients who were administered aliquots from vials of Avastin lot B3002B028 intravitreally, which was not distributed in the U.S.
Avastin is approved for the first-line or second-line treatment of metastatic colorectal cancer (MCRC) in combination with intravenous 5-FU (fluorouracil) based chemotherapy. Avastin is also approved for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel.
For more information call (800) 821-8590 or visit www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm126434.pdf.