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Important Safety Information

What is Avastin approved for?

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).

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?

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).

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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