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What are the benefits and risks of Avastin for metastatic colorectal cancer (mCRC)?

Avastin is approved to treat metastatic colorectal cancer, or mCRC, for first or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy. Avastin is also approved as a second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy, after cancer progresses following a first-line treatment that includes Avastin.

Keep in mind that Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor
  • In clinical studies, Avastin was shown to extend the life of patients with metastatic colorectal cancer when taken with IV 5-FU–based chemotherapy
  • Studies have also shown that there are some serious side effects that may occur with Avastin
Benefits and risks for patients who started on Avastin for an initial treatment

In studies, when patients took Avastin and IV 5-FU–based chemotherapy* for 1st or 2nd line treatment instead of chemotherapy alone:

The length of time people lived without their tumors growing or spreading increased significantly
More people saw their tumors shrink

Individual results may vary.

*
IV 5-FU–based chemotherapy for first and second-line treatment; fluoropyrimidine-based chemotherapy after cancer progresses following a first-line treatment that includes Avastin.


Possible serious side effects

Everyone reacts differently to Avastin therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

What are the side effects of Avastin in mCRC?

See the tables below for select side effects that increased by 2% or more in patients who added Avastin to IV 5-FU–based chemotherapy.

Side effects of Avastin and IV 5-FU–based chemotherapy: first-line

Severe to life-threatening side effects Chemo Alone Chemo + Avastin
Reduced white blood cell count 31% 37%
Diarrhea 25% 34%
Reduced white blood cell count that may increase the chance of infection 14% 21%
High blood pressure 2% 12%
Weakness 7% 10%
Blood clots in the veins of the body 5% 9%
Abdominal pain 5% 8%
Pain 5% 8%
Constipation 2% 4%
Blood clots inside the abdomen 1% 3%
A brief loss of consciousness 1% 3%

Side effects of Avastin and IV 5-FU–based chemotherapy: second-line

Severe to life-threatening and fatal side effects Chemo Alone Chemo + Avastin
Tiredness 13% 19%
Diarrhea 13% 18%
Nausea 5% 12%
Numbness and tingling in fingers and toes 9% 17%
Vomiting 4% 11%
Dehydration 5% 10%
High blood pressure 2% 9%
Abdominal pain 5% 8%
Nervous system disturbances 3% 5%
Severe bleeding 1% 5%
Blockage of the bowel 1% 4%
Headache 0% 3%
If my doctor changes my chemotherapy, how may Avastin continue to help?

If your chemotherapy treatment changes, continuing Avastin with a different chemotherapy may help extend the time you live without your tumor growing or spreading.

In a clinical study,* patients who continued on Avastin with this chemotherapy instead of chemotherapy alone:

  • Extended the time they live without their tumors growing or spreading
  • Lived longer

Individual results may vary.

*
Patients in this study took fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after their cancer progressed on an initial treatment that included Avastin.

Side effects of Avastin and IV 5-FU–based chemotherapy: first-line

Severe to life-threatening side effects Chemo Alone Chemo + Avastin
Reduced white blood cell count 31% 37%
Diarrhea 25% 34%
Reduced white blood cell count that may increase the chance of infection 14% 21%
High blood pressure 2% 12%
Weakness 7% 10%
Blood clots in the veins of the body 5% 9%
Abdominal pain 5% 8%
Pain 5% 8%
Constipation 2% 4%
Blood clots inside the abdomen 1% 3%
A brief loss of consciousness 1% 3%

Side effects of Avastin and IV 5-FU–based chemotherapy: second-line

Severe to life-threatening and fatal side effects Chemo Alone Chemo + Avastin
Tiredness 13% 19%
Diarrhea 13% 18%
Nausea 5% 12%
Numbness and tingling in fingers and toes 9% 17%
Vomiting 4% 11%
Dehydration 5% 10%
High blood pressure 2% 9%
Abdominal pain 5% 8%
Nervous system disturbances 3% 5%
Severe bleeding 1% 5%
Blockage of the bowel 1% 4%
Headache 0% 3%

When Avastin was used in second-line mCRC patients whose cancer had progressed on an initial treatment that included Avastin, the side effects were consistent with those seen in first- and second-line mCRC.

Important Safety Information

What is Avastin approved for?

Metastatic Colorectal Cancer (mCRC) Avastin is approved to treat metastatic colorectal cancer (mCRC) for:

  • First- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy
  • Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin

Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

  • Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
  • Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
  • A passage between two organs. This type of passage—known as a fistula—does not form normally and can sometimes be fatal
  • Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Rectal bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Avastin is not for everyone

Talk to your doctor if you are:

  • Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
  • Breast-feeding or pregnant. Avastin may harm a nursing child or a baby in the womb
  • Planning to become pregnant. Taking Avastin could cause a woman's ovaries to stop working and may impair her ability to have children. If you stop Avastin, you should keep using birth control for at least 6 months before trying to become pregnant

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.You may also report side effects to Genentech at 1-888-835-2555.

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

Questions about Avastin?
Call our 24 hour nurse support line: 1-877-428-2784

Glioblastoma (GBM) Avastin is approved to treat glioblastoma (GBM) when taken alone in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM). The effectiveness of Avastin in rGBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people with rGBM.

Metastatic Colorectal Cancer (mCRC) Avastin is approved to treat metastatic colorectal cancer (mCRC) for:

  • First- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy
  • Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin

Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

Non–Small Cell Lung Cancer (NSCLC) Avastin, in combination with carboplatin and paclitaxel, is approved to treat advanced nonsquamous non–small cell lung cancer (NSCLC) in people who have not received chemotherapy for their advanced disease.

Metastatic Kidney Cancer (mRCC) Avastin, used with interferon alfa, is approved to treat metastatic kidney cancer (mRCC).

Important Safety Information

What is Avastin approved for?

Metastatic Colorectal Cancer (mCRC) Avastin is approved to treat metastatic colorectal cancer (mCRC) for:

  • First- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy
  • Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin

Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

  • Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
  • Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
  • A passage between two organs. This type of passage—known as a fistula—does not form normally and can sometimes be fatal
  • Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Rectal bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Avastin is not for everyone

Talk to your doctor if you are:

  • Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
  • Breast-feeding or pregnant. Avastin may harm a nursing child or a baby in the womb
  • Planning to become pregnant. Taking Avastin could cause a woman's ovaries to stop working and may impair her ability to have children. If you stop Avastin, you should keep using birth control for at least 6 months before trying to become pregnant

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.You may also report side effects to Genentech at 1-888-835-2555.

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

Questions about Avastin? 24 hour nurse support line: 1-877-428-2784

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