Genentech Inc. has changed the labeling information for Avastin (bevacizumab) to warn physicians about reported cases of a rare brain-capillary leak syndrome and nasal septum deviation.
Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.
Cases of confirmed and possible reversible posterior leukoencephalopathy syndrome have been reported in patients receiving Avastin at a rate of less than 0.1% in clinical trials. The rare disorder is associated with hypertension, fluid retention, and the cytotoxic effects of immunosuppressive drugs on vascular endothelium.
The syndrome can present as headache, seizures, visual disturbance, and altered mental function. If patients develop the disorder, discontinue Avastin and initiate treatment of hypertension.
Resolution of improvement usually occurs in a few days. It is unknown whether it is safe to reinitiate Avastin therapy in patients who have experienced this disorder.
Prescribing information has also been changed to reflect seven cases of nasal septum deviation, reported as postmarketing events.
For more information, contact Genentech Inc. by calling 800-821-8590. To report any serious adverse events suspected to be associated with the use of Avastin, contact the company by calling 888-835-2555 or contact the Food and Drug Administration's MedWatch reporting system by visiting www.accessdata.fda.gov/scripts/medwatch