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Bevacizumab Injection

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IMPORTANT WARNING:

Posted 04/21/2007 Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). This multicenter, nonrandomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Bevacizumab (Avastin). There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the bevacizumab maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using bevacizumab and chemotherapy alone or with concurrent radiation treatment.

Bevacizumab is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with bevacizumab. Genentech intends to revise the bevacizumab package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with bevacizumab. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avastin, http://www.fda.gov/medwatch/safety/2007/Avastin_DHCP_TEF_Final_April2007.pdf and http://www.fda.gov/medwatch/safety/2007/Avastin_PI_apr07.pdf.

IMPORTANT WARNING:

Bevacizumab may cause you to develop a hole in the wall of your stomach or intestine. This is a serious and possibly life-threatening condition. If you experience any of the following symptoms, call your doctor immediately: stomach pain, constipation, nausea, vomiting, or fever.

Bevacizumab may slow the healing of wounds, such as cuts made by a doctor during surgery. In some cases, bevacizumab may cause a wound that has closed to split open. This is a serious and possibly life-threatening condition. If you experience this problem, call your doctor immediately. Tell your doctor if you have recently had surgery or if you plan to have surgery. If you have recently had surgery, you should not use bevacizumab until at least 28 days have passed and until the area has completed healed. If you are scheduled to have surgery, your doctor will stop your treatment with bevacizumab at least several weeks before the surgery.

Bevacizumab may cause severe, life-threatening bleeding in the lungs of people who are using bevacizumab along with chemotherapy to treat lung cancer. Tell your doctor if you have recently coughed up blood or if you cough up blood at any time during your treatment.

Talk to your doctor about the risks of using bevacizumab.

Why is this medication prescribed?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Bevacizumab is used with chemotherapy to treat cancer of the colon (large intestine) or rectum that has spread to other parts of the body. Bevacizumab is also used with chemotherapy to treat certain types of lung cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.

How should this medicine be used?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Bevacizumab comes as a solution to administer slowly into a vein. Bevacizumab is administered by a doctor or nurse in a medical office, infusion center, or hospital. Bevacizumab is usually given once every 2 weeks to treat cancer of the colon or rectum and once every 3 weeks to treat lung cancer.

It should take 90 minutes for you to receive your first dose of bevacizumab. A doctor or nurse will watch you closely to see how your body reacts to bevacizumab. If you do not have any serious problems when you receive your first dose of bevacizumab, it will usually take 30 to 60 minutes for you to receive each of your remaining doses of the medication.

Other uses for this medicine

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Bevacizumab is also sometimes used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities) and other types of cancer. Talk to your doctor about the risks of using bevacizumab to treat your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What storage conditions are needed for this medicine?

Bevacizumab will be stored in the medical office, infusion center, or hospital.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

headache

What other information should I know?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor. Your doctor will check your blood pressure and test your urine regularly during your treatment with bevacizumab.

Brand names

Avastin®

Notes:

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EditText of this page (last edited February 29, 2008)