Avastin is used with intravenous 5-FU based chemotherapy (IFL) as the first-treatment for patients with metastatic colon cancer (cancer of the colon or rectum that has spread to other areas of the body). IFL is a commonly used chemotherapy (medicine used to kill cancer cells) combination containing irinotecan, 5-fluorouracil (5-FU), and leucovorin for the treatment of colon cancer.

Avastin will not cure colorectal cancer that has spread. Overall, patients given Avastin plus intravenous 5-FU based chemotherapy had more tumors that shrank and survived about five months longer than patients given only intravenous 5-FU based chemotherapy. In addition, the average time before tumors restarted growing or new tumors appeared was four months longer than patients who were given only intravenous 5-FU based chemotherapy.

Special Warning(s) with Avastin:

• Avastin may cause gastrointestinal perforation (holes in the stomach, intestines or colon) requiring surgery to repair.
• Avastin may impair wound healing or cause wounds to open up. Avastin should not be started for at least 28 days following major surgery and full wound healing, and should be stopped before a scheduled surgery.
• Some patients with non–small cell lung cancer (for which Avastin is not approved) treated with chemotherapy and Avastin had bleeding from the lung tumor, spitting up of blood, leading to death.
• Avastin may cause a severe increase in blood pressure so patients receiving Avastin should have their blood pressure checked regularly.
• Avastin may cause proteinuria (protein in the urine, a sign of kidney damage).
• Avastin may cause congestive heart failure (failure of the heart to pump blood well).

General Precautions with Avastin:

• Avastin should be used with caution in patients who are allergic to Avastin or to any of the ingredients in Avastin

• Avastin may cause severe infusion reactions such as trouble breathing during the first or later doses