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Treatment for MCRC with Avastin Download

How Avastin May Affect Your Cancer

Avastin is a first-of-its-kind cancer therapy that is approved with IV 5-FU–based chemotherapy for first- or-second-line treatment of MCRC to help you live longer. This combination of treatments provides 2 distinct ways of attacking your cancer. IV 5-FU–based chemotherapy works 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 IV 5-FU–based 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 IV 5-FU–based chemotherapy were more likely to

  • Live longer than those who received chemotherapy alone
  • Have a longer time before their tumors grew than those who received chemotherapy alone
  • Have their tumors shrink by 50% or more, compared with those who received chemotherapy alone

While people benefited from combined treatment with Avastin plus IV 5-FU–based 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 MCRC?

In the first-line metastatic colorectal cancer trial, the most common severe to life-threatening side effects that increased by 2% or more in people who received Avastin plus IFL (chemotherapy) vs IFL (chemotherapy) alone were weakness (10% vs 7%), abdominal pain (8% vs 5%), pain (8% vs 5%), high blood pressure (12% vs 2%), blood clots in the veins of the body (9% vs 5%), blood clots inside the abdomen (3% vs 1%), a brief loss of consciousness (3% vs 1%), diarrhea (34% vs 25%), constipation (4% vs 2%), reduced white blood cell counts (37% vs 31%), and reduced white blood cell counts that may increase the chance of infection (21% vs 14%).

In the second-line metastatic colorectal cancer trial, the most common severe to life-threatening and fatal side effects that increased by 2% or more in people who received Avastin plus FOLFOX4 (chemotherapy) vs FOLFOX4 (chemotherapy) alone were diarrhea (18% vs 13%), nausea (12% vs 5%), vomiting (11% vs 4%), dehydration (10% vs 5%), blockage of the bowel (4% vs 1%), numbness and tingling in fingers and toes (17% vs 9%), nervous system disturbances (5% vs 3%), tiredness (19% vs 13%), abdominal pain (8% vs 5%), headache (3% vs 0%), high blood pressure (9% vs 2%), and severe bleeding (5% vs 1%).

Indication

Avastin, in combination with intravenous 5-FU–based chemotherapy, is approved by the FDA for first- or second-line treatment of people with metastatic cancer of the colon or rectum.

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 intravenous 5-FU–based chemotherapy, is approved by the FDA for first- or second-line treatment of people with metastatic cancer of the colon or rectum.

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:

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: