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
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 there are any signs of side effects.
Most serious side effects (not common, but sometimes fatal):
- GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your 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, be sure to tell your doctor
Other possible serious side effects
- 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
- Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
- Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include trouble breathing, chest pain, and sweating. Your doctor or nurse will monitor you for signs of infusion reactions
- Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
- A passage between two organs. This type of passage—known as a fistula—does not form normally and can sometimes be fatal
- Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness
Additional safety information
The most common side effects of Avastin are high blood pressure, too much protein in the urine, nosebleeds, rectal bleeding, back pain, headache, taste change, dry skin, inflammation of the skin, inflammation of the nose, and watery eyes.
Avastin is not for everyone. Talk to your doctor if you are:
- Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
- Breast-feeding, pregnant, or planning to become pregnant. Avastin may harm a nursing child or a baby in the womb. Also, Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children. If you stop Avastin, you should keep using birth control for at least 6 months before trying to become pregnant
If you have any questions about your condition or treatment, talk to your doctor.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see full Product Information, including Serious Side Effects, for additional important safety information.
Avastin® and the Access Solutions logo are registered trademarks of Genentech, Inc.