Indication

Avastin, in combination with carboplatin and paclitaxel (chemotherapy), is approved by the FDA for first-line treatment of people newly diagnosed with a common form of NSCLC (unresectable, locally advanced, recurrent, or metastatic non-squamous, non-small cell lung cancer).

Possible Serious Side Effects and Additional Important Safety Information

What is the most important safety information I should know about Avastin?

Avastin can result in the development of a potentially serious, and sometimes fatal, side effect called gastrointestinal (GI) perforation. GI perforation is the development of a hole in the stomach, small intestine, or large intestine. Symptoms may include abdominal pain, nausea, vomiting, constipation, and fever. Avastin therapy should be stopped if GI perforation occurs.

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. Stop Avastin for at least 28 days before voluntary surgery. Do not start Avastin for at least 28 days after surgery and until the surgical wound is fully healed. Avastin therapy should be stopped in patients who experience slow or incomplete wound healing.

Treatment with Avastin can result in serious and sometimes fatal bleeding. This includes coughing up blood, bleeding in the stomach, vomiting blood, bleeding in the brain, nosebleeds, and vaginal bleeding. People who have recently coughed up blood or have serious bleeding should not receive Avastin.

What are the additional possible serious side effects of Avastin?

Serious side effects with Avastin include:

• The formation of an abnormal passage from parts of the body to another part, sometimes fatal. Stop Avastin therapy if this occurs
• Stroke or heart problems, which can be fatal. Heart problems include blood clots, mini-stroke, heart attack, and chest pain. Stop Avastin therapy if these occur
• Too much protein in the urine, which may lead to kidney problems, sometimes fatal. Your doctor will monitor your protein level and may stop Avastin therapy if your level is too high
• High blood pressure. Your doctor will monitor your blood pressure and may start you on medications to control your blood pressure. Temporarily stop Avastin if not controlled with medications. Avastin should be stopped if blood pressure severely spikes or if disturbance of the brain from high blood pressure occurs
• Nervous system and vision disturbances. Symptoms may include high blood pressure, headache, seizure, sluggishness, confusion, and blindness. Stop Avastin therapy if these symptoms occur
• Infusion reactions. These may include high blood pressure or severe high blood pressure that may lead to stroke, difficulty breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headaches, tremors, and excessive sweating. Stop Avastin therapy if severe infusion reactions occur

What are the most common side effects of Avastin?

The most common side effects of Avastin that occurred at >10% and at least twice the control rate include 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, and inflammation of the skin.

What should I do if I am pregnant or thinking of becoming pregnant?

You should not take Avastin while you are pregnant. If you stop Avastin, you should use a contraceptive for at least 6 months after your last dose before attempting to become pregnant.

What should I tell my health care provider before taking Avastin?

Avastin therapy may not be appropriate for certain people. Talk to your doctor if you:

• Are pregnant or think you may be pregnant, or are planning to become pregnant. Based on animal data, Avastin may harm the fetus
• Are breast-feeding. Avastin may pass into your breast milk
• Are undergoing surgery. Avastin should not be given for at least 28 days after surgery and until the surgical wound is fully healed
• Are under the age of 18. The safety and efficacy of Avastin in children have not been evaluated

Please see full Product Information, including Serious Side Effects, for additional important safety information.