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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 you have symptoms related to these side effects.
The most serious side effects (not common, but sometimes fatal):
- Gastrointestinal (GI) perforation. A hole that develops in your stomach or intestine. Symptoms include pain in the 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; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, do not take Avastin
Other possible serious side effects:
- Abnormal passage in the body. This forms from one part of the body to another and can sometimes be fatal
- Stroke or heart problems. These include blood clots, mini-stroke, heart attack, and chest pain. These 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
- Nervous system and vision problems. Symptoms include high blood pressure, headache, seizure, sluggishness, confusion, and blindness
- Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
- Infusion reactions. These may include difficulty breathing, chest pain, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
- Fertility issues for women. Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
Glossary
A
- Abdomen:
- The area of the body that contains the pancreas, stomach, intestines, liver, gallbladder, and other organs.
- Adenocarcinoma:
- Cancer that begins in the cells that line certain internal organs. In NSCLC, it is usually found in the tissues of the lungs.
- Advanced nonsquamous non–small cell lung cancer (NSCLC):
- Nonsquamous non–small cell lung cancer that has spread to nearby areas.
- Angiogenesis:
- The growth of new blood vessels, a process that is critical to the growth and spread of cancer.
- Anti-angiogenesis:
- Preventing the growth of new blood vessels by blocking a protein released by tumors.
B
- Bronchi:
- The 2 main air passages leading from the windpipe (trachea) in the lungs. The bronchi provide passages for air to move in and out of the lungs.
C
- Chemotherapy:
- A type of treatment for cancer that is given either by mouth or infusion into a vein. Chemotherapy kills cancer cells by interfering with the tumor cell's ability to grow and reproduce. It affects all cells in your body that divide quickly, including some healthy cells.
- Clinical trial:
- A research study conducted with patients, designed to evaluate the safety and effectiveness of a new drug, usually in comparison with a standard treatment. If a drug is proven to work well in a clinical trial, it may become an FDA-approved new therapy that can help many people.
F
- First-line treatment:
- Initial treatment used to reduce a cancer. First-line therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains.
- FOLFOX4:
- An abbreviation for a type of combination chemotherapy that is used to treat colorectal cancer. It includes the chemotherapy drugs 5-fluorouracil, leucovorin, and oxaliplatin.
I
- IFL:
- An abbreviation for a type of combination chemotherapy that is used to treat colorectal cancer. It includes the chemotherapy drugs irinotecan, 5-fluorouracil, and leucovorin.
- Interferon alfa:
- A protein that the body normally makes in small amounts to fight infections and other diseases. It helps stop cancer cells from making new cancer cells and can slow cancer growth.
- Intravenous 5-FU–based chemotherapy (IV 5-FU):
- An abbreviation for a type of combination chemotherapy that is used to treat colorectal cancer. It includes the chemotherapy drugs 5-fluorouracil and leucovorin.
L
- Large cell undifferentiated carcinoma:
- A group of cancers in which the cells are large and look abnormal when viewed under a microscope.
- Lymph system:
- The tissues and organs that produce, store, and carry white blood cells that fight infections and other diseases.
M
- Metastatic colorectal cancer (mCRC):
- Colon or rectal cancer that has spread to other parts of the body.
- Metastasis:
- The spread of cancer from the primary site or origin to distant sites in the body.
- Metastatic kidney cancer (mRCC):
- Cancer that forms in the tissues of the kidneys and has spread to other places in the body.
P
- Pleural effusion:
- A collection of fluid, usually containing cancer cells, in the space between the lining of the lung (pleura) and the chest wall.
- Primary tumor:
- The original tumor. For example, a primary breast tumor is one that originally develops in the breast, as opposed to a metastatic tumor, which would develop in a different location as a result of the spreading of the primary tumor cells.
R
- Risk factor:
- Something that may increase the chance of developing a disease..
S
- Second-line treatment:
- Treatment that is given when initial treatment (first-line therapy) doesn't work, or stops working.
- Squamous cell carcinoma:
- Cancer that begins in squamous cells, which are found in the tissue that forms the surface of the skin, the lining of hollow organs of the body, and the passages of the respiratory and digestive tracts.
T
- Tumor:
- An abnormal lump or mass of tissue, which can be cancerous (malignant) or noncancerous (benign).
- Tumor-starving therapy:
- A therapy that starves tumors from what they need to grow and spread. Avastin is designed to starve tumors by blocking a protein, VEGF, which is produced by normal cells and overproduced by cancer cells.
V
- Vascular endothelial growth factor (VEGF):
- A protein made by cells that causes the formation of new blood vessels.
What Does Avastin Treat?
Avastin is approved for:
- Metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU–based chemotherapy for metastatic cancer
- Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease
- Metastatic kidney cancer (mRCC) when used with interferon alfa
- Glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment. The effectiveness of Avastin in GBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people previously treated for GBM
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 you have symptoms related to these side effects.
The most serious side effects (not common, but sometimes fatal):
- Gastrointestinal (GI) perforation. A hole that develops in your stomach or intestine. Symptoms include pain in the 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; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, do not take Avastin
Other possible serious side effects:
- Abnormal passage in the body. This forms from one part of the body to another and can sometimes be fatal
- Stroke or heart problems. These include blood clots, mini-stroke, heart attack, and chest pain. These 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
- Nervous system and vision problems. Symptoms include high blood pressure, headache, seizure, sluggishness, confusion, and blindness
- Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
- Infusion reactions. These may include difficulty breathing, chest pain, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
- Fertility issues for women. Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
Additional Safety Information
The most common side effects of Avastin are:
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Avastin is not right for everyone. Talk to your doctor if you:
- Are pregnant, may be pregnant, or are breast-feeding. Avastin may harm the fetus or a child that is nursing. If you stop Avastin, you should keep using birth control for at least 6 months after your last dose before trying to become pregnant
- Are undergoing surgery. Don’t take Avastin for at least 28 days before or after surgery and until surgical wounds are fully healed
If you have any questions about your condition or treatment, talk to your doctor.
Please see full Product Information, including Serious Side Effects, for additional important safety information.
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