What is Avastin?

Avastin is approved for:

• Metastatic colorectal cancer (mCRC) for first- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy. It is also approved to treat mCRC for second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin
  • Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.
• Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease
• Metastatic kidney cancer (mRCC) when used with interferon alfa
• Glioblastoma (GBM) when taken alone in adult patients whose cancer has progressed after prior treatment. The effectiveness of Avastin in GBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people previously treated for GBM

Possible Serious Side Effects

Everyone reacts differently to Avastin therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not.

Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if you have symptoms related to these side effects.

The most serious side effects (not common, but sometimes fatal):

• Gastrointestinal (GI) perforation. A hole that develops in your stomach or intestine. Symptoms include pain in the abdomen, nausea, vomiting, constipation, or fever
• Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
• Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, do not take Avastin

Other possible serious side effects:

• Abnormal passage in the body. This forms from one part of the body to another and can sometimes be fatal
• Stroke or heart problems. These include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
• Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
• Nervous system and vision problems. Symptoms include high blood pressure, headache, seizure, sluggishness, confusion, and blindness
• Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
• Infusion reactions. These may include difficulty breathing, chest pain, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
• Fertility issues for women. Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children

Additional Safety Information

The most common side effects of Avastin are:

Nosebleeds Headache High blood pressure Inflammation of the nose Too much protein in the urine Taste change

Dry skin Rectal bleeding Tear production disorder Back pain Inflammation of the skin

Avastin is not right for everyone. Talk to your doctor if you:

• Are pregnant, may be pregnant, or are breast-feeding. Avastin may harm the fetus or a child that is nursing. If you stop Avastin, you should keep using birth control for at least 6 months after your last dose before trying to become pregnant
• Are undergoing surgery. Don’t take Avastin for at least 28 days before or after surgery and until surgical wounds are fully healed

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.