Possible Serious Side Effects of Avastin Across Cancer Types

It is important to know that your body can react differently based on the type of cancer being treated and the type of therapy given.

In addition to advanced NSCLC, Avastin is also used to treat additional cancer types, including the diseases listed below. For information about possible side effects specific to Avastin and carboplatin and paclitaxel (chemotherapy) in the treatment of advanced NSCLC, click here.

Your health care team will talk to you about what to expect and how you can work with them to help manage the side effects of a therapy.

Across all trials, treatment with Avastin was permanently stopped in 8.4% to 21% of people because of side effects. Side effects seen across cancer types, some of which resulted in fatality, are as follows:

• Severe, and sometimes fatal, gastrointestinal (GI) perforation (the development of a hole in the stomach, small intestine, or large intestine) occurred more often in people who received Avastin therapy and was seen in 0.3% to 2.4% of those people
  • Most of the cases occurred within the first 50 days of starting Avastin therapy
  • Common signs of GI perforation include abdominal pain, nausea, vomiting, constipation, and fever
  • Avastin should be permanently stopped if GI perforation occurs
• Severe, and sometimes fatal, surgery and wound healing problems occurred more often in people who received Avastin therapy
  • Avastin should be stopped for at least 28 days before voluntary surgery. The length of time between stopping Avastin and having voluntary surgery without the risk of having surgery and wound healing problems has not been determined
  • Avastin should not be given for at least 28 days after major surgery and until the surgical wound is fully healed
  • Avastin should be permanently stopped if surgery and wound healing problems needing medical attention occur
  • The estimated length of time for Avastin to lose one half its initial effectiveness in the body (approximately 20 days) should be considered
• Avastin can cause 2 different types of bleeding: minor bleeding, most commonly mild nosebleeds, and serious, sometimes fatal, bleeding events
  • Severe, and sometimes fatal, bleeding occurred in 1.2% to 4.6% of people who received Avastin therapy
  • Serious bleeding included coughing up blood, bleeding in the stomach, vomiting blood, bleeding in the brain, nosebleeds, and vaginal bleeding. These events occurred up to 5 times more often in people who received Avastin compared to people who received chemotherapy alone
  • People who have recently coughed up blood (greater than or equal to half a teaspoon of red blood) or with serious bleeding should not receive Avastin
  • Avastin should be permanently stopped if severe bleeding occurs
• Severe, and sometimes fatal, non-GI fistula formation (the development of an abnormal passage outside the GI tract) was seen in 0.3% or less of people who received Avastin. Avastin should be permanently stopped if a fistula formation involving an internal organ occurs
• Severe, and sometimes fatal, stroke or heart problems were seen in 2.4% of people who received Avastin therapy
  • Heart problems included blood clots, mini-stroke, heart attack, and chest pain
  • Avastin should be permanently stopped if severe stroke or heart problems occur
• Severe to life-threatening high blood pressure was seen in 5% to 18% of people who received Avastin therapy
  • During treatment with Avastin, blood pressure should be monitored every 2 to 3 weeks
  • People who develop high blood pressure on Avastin may require more frequent monitoring, and those who stop Avastin treatment at their doctor's direction should continue to be monitored regularly
  • Avastin should be temporarily stopped in people with severe high blood pressure that is not controlled with medical treatment. Avastin should be stopped if blood pressure severely spikes or if disturbance of the brain from high blood pressure occurs
• Less than 0.1% of people who received Avastin therapy in clinical trials experienced nervous system and vision disturbances, known as RPLS (reversible posterior leukoencephalopathy syndrome)
  • Symptoms may include high blood pressure, headache, seizure, sluggishness, confusion, and blindness
  • Avastin should be permanently stopped if RPLS develops. Symptoms usually go away or improve within days, although some people have experienced ongoing nervous system disturbances. The safety of restarting Avastin therapy in people who have experienced RPLS is not known
• Too much protein in the urine, which led to serious kidney problems, was seen in less than 1% of people who received Avastin therapy
• Because Avastin is given as an infusion, infusion reactions may occur. In clinical trials, infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3% of people, and severe reactions occurred in 0.2% of people. Your doctor or nurse will monitor you for signs of an infusion reaction that may include high blood pressure, 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. The infusion should be stopped and medical treatment should be given if a severe infusion reaction occurs

Common side effects across all cancer types

Common side effects that occurred in more than 10% of people who received Avastin for different cancer types were 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 (exfoliative dermatitis).

What other safety information should I know?

Avastin may impair fertility. If you are pregnant or thinking of becoming pregnant, talk with your doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least 6 months following the last dose of Avastin. Nursing mothers should not breast-feed while receiving Avastin, or for a short period of time after treatment is finished.