Bevacizumab Injection (patient information)

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.

ANOTHER 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 this medication is prescribed
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 this medication should 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.

Special precautions
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.

Before receiving bevacizumab:
 * tell your doctor and pharmacist if you are allergic to bevacizumab or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulants (blood thinners) such as warfarin (Coumadin) and irinotecan (Camptosar). Also *tell your doctor if you are taking or if you have ever taken an anthracycline (a type of chemotherapy used for breast cancer and some types of leukemia) such as daunorubicin (Cerubidine), doxorubicin (Adriamycin, Rubex), epirubicin (Ellence), or idarubicin (Idamycin). *Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor if you have ever been treated with radiation therapy to the left side of your chest, and if you have or have ever had cancer that spread to your brain or spine, high blood pressure, or any condition that affects your heart or blood vessels (tubes that move blood between the heart and other parts of the body).
 * tell your doctor if you are pregnant or plan to become pregnant. Bevacizumab may harm the fetus and increase the risk of a pregnancy loss. You should use birth control to prevent pregnancy during your treatment with bevacizumab and for some time after you stop using the medication. If you become pregnant while using bevacizumab, call your doctor.
 * tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with bevacizumab and for some time after you stop using the medication.

Before receiving bevacizumab:


 * tell your doctor and pharmacist if you are allergic to bevacizumab or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulants (blood thinners) such as warfarin (Coumadin) and irinotecan (Camptosar). Also *tell your doctor if you are taking or if you have ever taken an anthracycline (a type of chemotherapy used for breast cancer and some types of leukemia) such as daunorubicin (Cerubidine), doxorubicin (Adriamycin, Rubex), epirubicin (Ellence), or idarubicin (Idamycin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor if you have ever been treated with radiation therapy to the left side of your chest, and if you have or have ever had cancer that spread to your brain or spine, high blood pressure, or any condition that affects your heart or blood vessels (tubes that move blood between the heart and other parts of the body).
 * tell your doctor if you are pregnant or plan to become pregnant. Bevacizumab may harm the fetus and increase the risk of a pregnancy loss. You should use birth control to prevent pregnancy during your treatment with bevacizumab and for some time after you stop using the medication. If you become pregnant while using bevacizumab, call your doctor.
 * tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with bevacizumab and for some time after you stop using the medication.

Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose
If you miss an appointment to receive a dose of bevacizumab, call your doctor as soon as possible.

Minor Side Effects
Bevacizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * dizziness
 * fainting
 * nosebleeds
 * bleeding gums
 * weakness
 * loss of appetite
 * heartburn
 * change in ability to taste food
 * diarrhea
 * weight loss
 * dry mouth
 * sores on the skin or in the mouth
 * voice changes

Severe Side Effects
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:


 * nosebleeds that cause dizziness or fainting or that do not stop after 10 to 15 minutes
 * unusual bruising or bleeding
 * black or bloody stools
 * bright red blood in stools
 * vomit that is bloody or looks like coffee grounds
 * severe vaginal bleeding
 * headache
 * neck pain
 * low or difficult speech
 * dizziness or faintness
 * weakness or numbness of an arm or leg
 * chest pain
 * pain in the arms, neck, or upper back
 * shortness of breath
 * seizures
 * extreme tiredness
 * confusion
 * change in vision or loss of vision
 * sore throat, fever, chills, and other signs of infection
 * swelling of the face, eyes, stomach, hands, feet, ankles, or lower legs
 * unexplained weight gain
 * foamy urine
 * dry, hacking cough
 * pain, tenderness, warmth, redness, or swelling in one leg only
 * redness, itching, or scaling of the skin

Bevacizumab may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

Storage conditions needed for this medication
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
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®