Possible Side Effects of Avastin & IV 5-FU–Based Chemotherapy in the Treatment of MCRC

Possible serious side effects in first-line and second-line treatment of MCRC

People receiving Avastin plus IV 5-FU–based chemotherapy for first-line or second-line treatment of MCRC may experience some of the following serious side effects. Some of these have been fatal.

15% of people who received Avastin plus IV 5-FU–based chemotherapy for the first-line treatment of MCRC experienced wound healing problems after surgery
Nosebleeds were seen in 35% of people who received Avastin plus IFL (chemotherapy)
- All nosebleeds but one were mild and did not require medical treatment
Mild to moderate bleeding events seen in people who received Avastin plus IV 5-FU–based chemotherapy for the first-line treatment of MCRC included gastrointestinal tract bleeding (24%), minor gum bleeding (2%), and vaginal bleeding (4%)
Severe to life-threatening blood clots, including those in the deep veins of the body or in the veins of the stomach, were seen in 15.1% of people who received Avastin plus IV 5-FU–based chemotherapy for the first-line treatment of MCRC
- Of these people, 14% received a blood thinner. Of those, 21% had a second blood clot
Severely reduced white blood cell counts were seen in 21% of people who received Avastin plus IV 5-FU–based chemotherapy for the first-line treatment of MCRC
Too much protein in the urine, which may be a sign of kidney problems, was seen in 0.7% to 7.4% of people across several cancer types
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%)

Side effects of IV 5-FU–based chemotherapy

Some different side effects you may experience are associated with the IV 5-FU–based chemotherapy part of your treatment. These include loss of appetite, mouth sores, low blood cell counts, sensitivity to sunlight, and a syndrome of hand and foot redness that is sometimes accompanied by blistering or skin peeling.

If any of the above side effects occur, your doctor can help you manage them.

Avastin therapy may not be right for everyone. Check with your doctor if you think any of the listed conditions apply to you or if you are experiencing any of these serious side effects.

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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:

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.