Important Safety Information

Patients treated with targeted therapies, including Avastin, may experience side effects. In clinical trials, some patients treated with Avastin experienced serious side effects, including:

Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a potentially serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, these events occurred throughout the course of treatment, and in some cases, resulted in fatality. Avastin therapy should be permanently stopped in people with GI perforation.

Wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Avastin therapy should be permanently stopped in patients with wound healing problems that require medical treatment. The appropriate waiting time between stopping treatment with Avastin and having surgery has not been determined.

Severe bleeding: Some people receiving Avastin with chemotherapy for lung cancer experienced coughing up blood (hemoptysis). In some cases, this event resulted in fatality. People with recent hemoptysis should not receive Avastin.

In clinical trials, additional serious side effects seen across different cancer types include a higher risk of stroke or heart problems (blood clots and congestive heart failure), in some cases resulting in fatality, compared with people taking chemotherapy alone. Some people experienced a condition that causes reduced white blood cell counts that may increase the chance of infection (neutropenia). Some people experienced the formation of an abnormal passage from parts of the body to another part (non-GI fistula formation), in some cases resulting in fatality. Severe high blood pressure, kidney problems, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome) were also experienced by some people taking Avastin with chemotherapy.
Patients receiving Avastin should have their blood pressure monitored every 2-3 weeks.

Avastin may cause problems getting pregnant. If you are pregnant or thinking of becoming pregnant, talk to your doctor about the potential risks of loss of pregnancy or the potential risk of Avastin to the fetus. Nursing mothers should not breast-feed while receiving Avastin, or for a short period of time after treatment is finished

In the first-line metastatic colorectal cancer trial, the most common serious adverse events which increased by more than 2% for Avastin plus chemotherapy (IFL) versus chemotherapy alone were weakness, abdominal pain, pain, high blood pressure, blood clots, a brief loss of consciousness, diarrhea, constipation, and reduced white blood cell counts.

In the second-line metastatic colorectal cancer trial, the most common serious adverse events which increased by more than 2% for Avastin plus chemotherapy (FOLFOX4) versus chemotherapy alone were diarrhea, nausea, vomiting, dehydration, blockage of the bowel, numbness and tingling in fingers and toes, nervous system disturbances, tiredness, abdominal pain, headache, high blood pressure, and severe bleeding.

Please see accompanying full Product Information, including Boxed WARNINGS, for additional safety information.