How Avastin May Affect Your Cancer

Avastin is a first-of-its-kind cancer therapy that is approved with carboplatin and paclitaxel (chemotherapy) to help you live longer. This combination of treatments provides 2 distinct ways of attacking your cancer. Carboplatin and paclitaxel (chemotherapy) work by attempting to destroy cancer cells by stopping them from growing or dividing. Avastin works by starving the tumor of what it needs to grow and spread. Because Avastin and carboplatin and paclitaxel (chemotherapy) attack cancer in different ways, they are given together for a combined fight to help control your cancer and extend survival.

On average, people in clinical trials receiving Avastin plus carboplatin and paclitaxel (chemotherapy) were more likely to

Live longer than those who received carboplatin and paclitaxel (chemotherapy) alone
Have a longer time before their tumors grew than those who received carboplatin and paclitaxel (chemotherapy) alone

These benefits were seen when Avastin was continued for as long as the disease was controlled, or until side effects became unmanageable.

While people benefited from combined treatment with Avastin plus carboplatin and paclitaxel (chemotherapy), there were also some side effects because both therapies may affect normal cells. It is important that you discuss with your health care team how to manage these or any other side effects of your cancer treatment.

What is the safety information for Avastin in advanced NSCLC?

In the advanced non-small cell lung cancer trial, the most common life-threatening to fatal side effects that increased by 2% or more in people who received Avastin vs those in the comparison group were reduced white blood cell counts (27% vs 17%), tiredness (16% vs 13%), high blood pressure (8% vs 0.7%), infection without reduced white blood cell counts (7% vs 3%), blood clots in the veins of the body (5% vs 3%), fever with reduced white blood cell counts (5% vs 2%), inflammation of the lungs (5% vs 3%), infection with severe or life-threatening reduced white blood cell counts (4% vs 2%), low sodium levels in the blood that could lead to seizure or coma (4% vs 1%), headache (3% vs 1%), and too much protein in the urine (3% vs 0%).

Next Page: How Will I Receive Avastin?

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).

Serious Side Effects

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.

Please click here for additional important safety information.

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.