Important Safety Information

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.

Surgery and 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. Surgery and wound healing problems occurred more often in people who received Avastin. Avastin therapy should not be started for at least 28 days after surgery or until the surgical wound is fully healed. The length of time between stopping Avastin and having elective surgery without the risk of having wound healing problems has not been determined. Stop treatment with Avastin at least 28 days before elective surgery and in people with wound healing problems that require medical treatment.

Severe bleeding: Treatment with Avastin can result in serious bleeding, including coughing up blood, gastrointestinal bleeding, bleeding in the brain, nosebleeds, and vaginal bleeding. These events occurred up to five-fold more often in people who received Avastin, and in some cases resulted in fatality. Across cancer types, 1.2% to 4.6% of people who received Avastin experienced grade 3 or higher bleeding events. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Permanently stop treatment with Avastin if serious bleeding occurs (ie, requiring medical attention).

In clinical trials for different cancer types, additional serious side effects that occurred in more people who received Avastin than those in the comparison group were the formation of an abnormal passage from parts of the body to another part (non-GI fistula formation), stroke or heart problems, severe high blood pressure, nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), too much protein in the urine and kidney problems, and infusion reactions.

The most common grade 3-5 (not blood-related) and 4-5 (blood-related) events that occurred in more people who received Avastin than the comparison group were reduced white blood cell counts that may lead to infection, tiredness, high blood pressure, bleeding, weakness, abdominal pain, pain, blood clots, including those in the deep veins of the body or in the veins of the stomach, a brief loss of consciousness, diarrhea, constipation, nausea, vomiting, dehydration, blocking of the bowel, nervous system disturbances, headache, infection, too much protein in the urine, and stroke.

Common side effects that occurred in more than 10% of people who received Avastin for different cancer types were nosebleeds, headache, high blood pressure, irritation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, and inflammation of the skin (exfoliative dermatitis).

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