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What are the possible side effects of 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 these 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 other possible serious side effects?

% = Percentage of patients who had this side effect in clinical studies across different cancers

Severe high blood pressure
18%
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
7%
These may be caused by too much protein in the urine and can sometimes be fatal
Infusion reactions
3%
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
2.6%
These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
Abnormal passage in the body
2%
This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
Nervous system and vision problems
0.5%
Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

What are the 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
Pregnant, or think you are pregnant
Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant
Planning to become pregnant
Taking Avastin could cause a woman's ovaries to stop working and may impair her ability to have children
Breastfeeding
Breastfeeding while on Avastin may harm your baby and is therefore not recommended

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


Side effects of Avastin in mCRC

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

% = Percentage of patients who had this side effect in clinical studies across different cancers

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

% = Percentage of patients who had this side effect in clinical studies across different cancers

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, no new safety signals were observed. The side effects were consistent with those seen in first- and second-line mCRC.

Side effects of Avastin in advanced NSCLC

What are the side effects of Avastin in advanced NSCLC?

See the table below for select side effects that increased by 2% or more in patients who added Avastin to carboplatin and paclitaxel (chemotherapy).

% = Percentage of patients who had this side effect in clinical studies across different cancers

Life-threatening to fatal side effects Chemo Alone Chemo + Avastin
Lower than normal white blood cell count
17%
27%
Tiredness
13%
16%
High blood pressure
0.7%
8%
Infection without lower than normal white blood cell count
3%
7%
Blood clots in the veins
3%
5%
Lung inflammation
3%
5%
Fever with reduced white blood cell count
2%
5%
Infection with lower than normal white blood cell count
2%
4%
Abnormally low sodium that could lead to seizure or coma
1%
4%
Headache
1%
3%
Too much protein in the urine
0%
3%
Side effects of Avastin in mRCC

What are the side effects of Avastin in mRCC?

See the table below for select side effects that increased by 2% or more in patients who added Avastin to interferon alfa.

Side effects of Avastin in mRCC

% = Percentage of patients who had this side effect in clinical studies across different cancers

Severe to fatal side effects Interferon Alfa Alone Interferon Alfa + Avastin
Fatigue
8%
13%
Weakness
7%
10%
Too much protein in the urine
0%
7%
High blood pressure
1%
6%
Bleeding
0.3%
5%
Side effects of Avastin in CC

What are the serious side effects of Avastin in CC?

A blood clot in the veins
10.6%
This may lead to mini-stroke, heart attack, and chest pain, which could be fatal.
Abnormal passage in the body
Up to 8.3%
This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal.
  • 8.3% of patients developed a fistula between an organ in the digestive system and the vagina
  • 1.8% developed a fistula between 2 non-digestive organs

Serious side effects of Avastin in cervical cancer

Select serious side effects that increased by 2% or more in patients who added Avastin to chemotherapy:

Life-threatening to fatal side effects Chemo Alone Chemo + Avastin
Tiredness
9.9%
14.2%
Abdominal pain
9.9%
11.9%
High blood pressure
0.5%
11.5%
Blood clot formation
2.7%
8.3%
Urinary tract infections
6.3%
8.3%
Lower than normal white blood cell count:
Neutropenia
4.1%
7.8%
Lymphopenia
3.2%
6.0%
Low potassium
4.5%
7.3%
Diarrhea
2.7%
5.5%
Back pain
3.2%
5.5%
Pain in the lower part of your abdomen
1.4%
5.5%
Dehydration
0.5%
4.1%
Abnormal opening at or near the anus
0%
3.7%
Abnormally low sodium that could lead to seizure or coma
1.4%
3.7%
Skin infection
0.5%
3.2%
Pain at the anus or rectum
0%
2.8%
Side effects of Avastin in prOC

What are the side effects of Avastin in prOC?

The most common severe to life-threatening side effects that increased by 2% or more in people who received Avastin plus chemotherapy (compared with those receiving chemotherapy alone):

Side effects Chemo Alone Chemo + Avastin
High blood pressure
1.1%
6.7%
Hand-foot syndrome
1.7%
4.5%

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.

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).

Advanced Cervical Cancer (CC) Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix.

Platinum-Resistant Ovarian Cancer (prOC) Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments.

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 these 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

  • Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
  • 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
  • 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
  • Pregnant, or think you are pregnant. Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant
  • Planning to become pregnant. Taking Avastin could cause a woman's ovaries to stop working and may impair her ability to have children
  • Breastfeeding. Breastfeeding while on Avastin may harm your baby and is therefore not recommended

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 nurse support line 7 days a week: 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).

Advanced Cervical Cancer (CC) Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix.

Platinum-Resistant Ovarian Cancer (prOC) Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments.

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.

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).

Advanced Cervical Cancer (CC) Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix.

Platinum-Resistant Ovarian Cancer (prOC) Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments.

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 these 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

  • Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
  • 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
  • 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
  • Pregnant, or think you are pregnant. Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant
  • Planning to become pregnant. Taking Avastin could cause a woman's ovaries to stop working and may impair her ability to have children
  • Breastfeeding. Breastfeeding while on Avastin may harm your baby and is therefore not recommended

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? 7 days a week nurse support line: 1‑877‑428‑2784

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