What is Avastin used for?

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.

• 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).

• 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

Tell your health care provider if you:

• have or had liver or kidney problems
• have high blood pressure
• have congestive heart failure or other heart problems
• are pregnant, are trying to become pregnant, or are breast-feeding
• if you have recently had surgery or are planning to have surgery

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Avastin works or Avastin may affect how your other medicines work.

(This list is NOT a complete list of side effects reported with Avastin. Your health care provider can discuss with you a more complete list of side effects.)

Serious side effects include of Avastin treatment include:

• gastrointestinal perforation
• impaired wound healing
• severe bleeding
• a dangerously high increase in blood pressure
• kidney damage
• congestive heart failure

More common side effects of Avastin treatment include:

• tiredness and weakness
• stomach pain
• headache
• high blood pressure
• diarrhea
• nausea and vomiting
• loss of appetite
• mouth sores
• constipation
• lung infections
• nose bleeds
• shortness of breath
• decreased white blood cells
• skin peeling
• protein in the urine

For more detailed information about Avastin, ask your health care provider or pharmacist.

U.S. Food and Drug Administration